Ophthalmology Update - Cleveland Clinic

O ne of the nation’s most important clinical

trials in exudative age-related macular

degeneration — the Comparison of AMD

Treatments Trials (CATT) — is led by Daniel F. Martin,

MD, Chairman of Cleveland Clinic’s Cole Eye Institute.

Now, a researcher at Cole Eye Institute has received a

two-year, $900,000 National Eye Institute challenge

grant for an innovative, first-of-its kind project aimed

at studying the genetic makeup of the majority of the

1,208 CATT participants.

AMD genotype MAy preDict response

CATT is designed to determine the relative efficacy

of two drugs — ranibizumab (Lucentis®) and bevaci-

zumab (Avastin®) — for the treatment of age-related

macular degeneration.

The work of Stephanie A. Hagstrom, PhD, will define

the AMD genotype in CATT patients to reveal which

genetic traits make a patient more likely to have a

favorable response to each treatment, both of which

block vascular endothelial growth factor (VEGF), an

important driver of retinal angiogenesis.

“We hope to correlate specific single nucleotide

polymorphisms (SNPs) with a patient’s response to

anti-VEGF therapy. It is possible that patients with

the major AMD risk genotypes will not respond to

treatment as well as patients who have other genetic

variants,” Dr. Hagstrom says.

Looking AheAD to personALizeD MeDicine

“We hope the results from this pharmacogenetic

study will allow ophthalmologists to offer personal-

ized medicine based on a patient’s underlying genetic

background,” she adds.

CATT began enrolling patients with newly diagnosed,

untreated neovascular AMD in February 2008. Patients

were randomly assigned to one of four treatment arms:

ranibizumab given monthly, bevacizumab given monthly,

ranibizumab given PRN or bevacizumab given PRN.

Genetics of AMD Being Studied by Researchers at Cole Eye Institute

Cole Eye Institute Spring 2011

Ophthalmology Update

Continued on page 2

Stephanie A. Hagstrom, phD

Ocular Inflammation Can Signal Underlying Systemic Disease

page 6

AMD: Combination Therapy Is More Convenient, but Not Superior

page 3

Case Study: Cole Eye Special-ists Join Fetal Care Center Team

page 4

Research Seeks to Elucidate Causes of Acute Retinal Necrosis

page 8

Also Inside: Clinical Trials and Basic Research; Cole Eye CME, Distinguished Lecture Series & Grand Rounds

2 ophthalmology Update | spring 2011

All patients are evaluated every four weeks at one

of the 44 participating clinical centers. The primary

outcomes measures are visual acuity at one year and

at two years.

At LeAst 35 snps to be genotypeD

Dr. Hagstrom’s study team began collecting samples

in late summer 2010. At least 35 SNPs will be

genotyped, including those that have previously been

shown to have the strongest associations with AMD.

Dr. Hagstrom expects to recruit the majority of CATT

participants because they are already committed to the

original trial.

“Patients will have several opportunities to join the

study because they are seen every month,” she says.

MeAsUring response by genotype

Genotype and clinical measures of response to

anti-VEGF therapy will be compared. The clinical

responses measured will be:

• Visual acuity

• Presence or absence of subretinal, intraretinal

or sub-retinal pigment epithelial (sub-RPE) f luid

as seen on optical coherence tomography

• Retinal thickness

• Lesion size as seen on f luorescein angiography

• Number of treatments deemed necessary by

the clinician for patients assigned to the PRN

treatment arms

Dr. Martin calls this genetic study a high-profile,

timely undertaking that effectively utilizes the work

already being done for CATT. “Dr. Hagstrom’s work

will generate valuable data that will help propel us

into a new era in the treatment of macular degenera-

tion,” he says.

Contact Dr. Stephanie Hagstrom or Dr. Daniel Martin

at [email protected].

Continued from page 1 “We hope to correlate specific single nucleotide polymorphisms (SNPs)

with a patient’s response to anti-VEGF therapy. It is possible that patients

with the major AMD risk genotypes will not respond to treatment as well

as patients who have other genetic variants.”

— Stephanie A. Hagstrom, PhD (pictured at lower left)

clevelandclinic.org/oUspring 3

Combined AMD Therapy More Convenient, Not Superior

V erteporfin with photodynamic therapy (PDT)

blocks choroidal neovascularization using a differ-

ent mechanism than ranibizumab therapy. Oph-

thalmologists have wondered if combining both therapies

might maximize visual results while minimizing treat-

ments for patients with age-related macular degeneration.

In DENALI, a multicenter, randomized, double-masked,

controlled phase IIIb clinical trial in the United States

and Canada, investigators compared a combination of

standard-fluence or reduced-fluence verteporfin PDT and

ranibizumab to ranibizumab monotherapy. They docu-

mented similar visual results in the three treatment groups

but found combination therapy to be inferior to monthly

ranibizumab injections.

Peter K. Kaiser, MD, a retina specialist at Cleveland Clinic’s

Cole Eye Institute and Study Chairman of DENALI,

explains that the mean change in vision would have had to

be within seven letters of visual improvement to demon-

strate that combination therapy was not inferior to monthly

ranibizumab.

“Although both combination therapy groups were within

approximately four letters of monthly ranibizumab, the

primary outcome was not met because our results were just

outside that 95 percent confidence interval,” he says.

Fewer sessions MAy iMprove coMpLiAnce

However, Dr. Kaiser emphasizes that the visual results ob-

tained with combination therapy were very similar to those

obtained with monthly ranibizumab injections and only

required about half as many treatments.

“Combination therapy is definitely more convenient for

patients and is more cost-effective, and delivers results

that are very similar,” he says. In the DENALI study,

patients in the combination group received an average of

five treatments over the course of a year while patients on

ranibizumab monotherapy received 10.5. “This number

should be closer to 12, but not all patients managed to keep

every appointment, which demonstrates part of the appeal

of combination therapy,” Dr. Kaiser notes.

no ADvAntAge to reDUceD FLUence

Investigators also compared standard-fluence PDT (light

intensity 600 mW/cm2) with reduced-fluence PDT (light

intensity 300 mW/cm2) in hopes that the latter would yield

superior results. That did not prove to be the case.

“Since we found no benefit to using reduced fluence, clini-

cians should stay with the on-label standard PDT when per-

forming combination therapy,” Dr. Kaiser says. Clinicians

should view combination therapy not as first-line treatment

for most AMD patients, he says, but as an alternative for pa-

tients who must travel long distances or have other barriers

to keeping appointments or who do not respond adequately

to ranibizumab monotherapy.

one MAjor exception: pcv

Patients with polypoidal choroidal vasculopathy (PCV) are

an exception to this rule, says Dr. Kaiser. Another study

showed combination therapy to yield similar visual results

and better polyp reduction than ranibizumab monotherapy

in these patients’ eyes.

“In the EVEREST study, the visual results with PCV

patients in all treatment groups initially appeared similar.

However, indocyanine green chorioangiography dem-

onstrated that combination therapy was more effective

at achieving a complete regression of the polyps — in

80 percent of patients versus 30 percent of ranibizumab

monotherapy patients,” Dr. Kaiser says.

“We think ranibizumab causes the fluid around the polyps

to regress, which initially helps vision, but once the ranibi-

zumab is stopped, the polyps remain, the fluid returns and

vision degenerates quickly.”

Contact Dr. Peter Kaiser at [email protected].

peter K. Kaiser, MD

Cole Eye Specialists Join Fetal Care Center Team When Orbital Cyst Is Diagnosed in Utero

Arun Singh, MD

Elias Traboulsi, MD

Cleveland Clinic’s Fetal Care Center facilitates diagnosis and offers

counseling when fetal or maternal problems arise, then orchestrates

delivery and immediate postnatal treatment. Team members shift as

each clinical situation demands. When an orbital cyst was revealed

on a fetal ultrasound, Cole Eye Institute specialists were called in.

Case Study:


Ultrafast fetal Mri shows an intraconal cyst

involving the right orbit that produced marked

proptosis but minimal globe deformity.


in this case, ophthalmic oncologist Arun Singh, MD, pediatric

ophthalmologist/ophthalmic geneticist Elias Traboulsi, MD,

and a pediatric neurosurgeon joined the Fetal Care Center’s

maternal-fetal medicine specialists, neonatologists and fetal imag-

ing specialists. The center’s advanced practice nurses coordinated

the entire process, communicating with and supporting the family.

History: An ultrasound for an unrelated obstetric concern in a

28-year-old G2P0 woman revealed an orbital cyst in the fetus at 27

weeks, 6 days estimated gestational age. The 4 cm x 2 cm cyst behind

the right eye occupied the right orbit, with a high likelihood of ocular

malformation as development progressed. The left orbit appeared

normal. The mother and father were advised of concerns about fetal

brain development, although ultrasound findings appeared normal,

and sought a second opinion in Cleveland Clinic’s Fetal Care Center.

Maternal-fetal medicine consult: The next day, Sept. 17, the couple

met with maternal-fetal medicine specialist Jeffrey Chapa, MD, for

a repeat ultrasound and consultation. Imaging revealed the cystic

mass posterior to the right eye; however, the globe, including the

lens and extraocular muscles, appeared to be intact. The eye was

severely proptotic, protruding from the orbit. Cesarean section

was planned to avoid potential trauma to the globe during passage

through the birth canal. Left eye findings were unremarkable, as

were intracranial anatomy and the remaining fetal anatomy.

Fetal MRI: Ultrafast fetal MRI, obtained the following day in the

Fetal Imaging Center, showed an intraconal cyst involving the right

orbit that produced marked proptosis but minimal globe deformity.

Pediatric imaging specialists Janet Reid, MD, and Stuart Morrison,

MD, believed the location and appearance suggested a lymphatic

or venolymphatic malformation or, less likely, a colobomatous cyst.

Because the finding was relatively recent, concerns were raised

regarding rapid progression of the cystic structure. A follow-up

MRI was planned for two weeks later.

Ophthalmology consult: After another visit with Dr. Chapa, the

couple had a prenatal consult on Sept. 23 with Dr. Singh, Director

of Ophthalmic Oncology at Cole Eye Institute. Dr. Singh discussed

the ultrasound and fetal MRI findings with them, describing

potential diagnoses and treatments for the orbital mass based on the

findings at birth. The repeat fetal MRI on Sept. 30 showed relatively

little change, and surveillance continued via ultrasound for the

remainder of the pregnancy.

Orchestrating delivery: The Cesarean section was scheduled for

Dec. 1. Standing by Dr. Chapa’s maternal-fetal medicine team and

neonatologists Ricardo Rodriguez, MD, and Sabine Iben, MD, were

Dr. Singh and his ophthalmic surgical team, Dr. Traboulsi, and pedi-

atric neurosurgeon Mark Luciano, MD. Side-by-side operating rooms

were reserved. The father was present at delivery, and the baby was

promptly assessed. The father then carried his daughter to the adjoin-

ing OR for further evaluation.

Prompt team assessment: Drs. Singh, Traboulsi and Luciano were

concerned that the proptosis worsened when the baby cried. They

quickly decided that further imaging was needed to determine the

cyst’s possible etiology prior to any invasive procedure. Dr. Singh

placed a temporary tarsorrhaphy to protect what appeared to be the

functional right globe.

Surgery and follow-up: Imaging revealed that the cyst had no

communication with any intracranial structures. Under the care

of Drs. Singh and Traboulsi, the baby underwent two surgeries for

partial cyst removal, with histopathologic confirmation of a benign

squamous epithelial cyst. At 6 months of age, the baby was grow-

ing and thriving, the cyst had not recurred, and she had good use

and function in the right eye. Follow-up would be needed to check

for cyst recurrence. The baby would likely need surgery, including

cosmetic surgery.

Contact Dr. Arun Singh or Dr. Elias Traboulsi


right: A temporary tarsorrhaphy protected the baby’s

apparently functional right globe. Far right: by 6 months of

age, after two surgeries for partial cyst removal, the baby

was growing and thriving.

Careen Y. Lowder, MD, phD

rula Hajj-Ali, MD


Ocular Inflammation Can Signal Underlying Systemic DiseaseInterdisciplinary Collaboration Improves Care and Outcomes

A ctive uveitis and scleritis are often associated

with a systemic illness and poor visual outcomes.

Complications of ocular inflammation include

macular edema, retinal and optic nerve neovascularization,

vitreous hemorrhage, cataract, glaucoma, and retinal tears

and/or detachment.

Uveitis patients require aggressive treatment to preserve

vision and prevent secondary complications. Two-thirds

of scleritis patients require systemic immunosuppressive

medications to control both ocular inflammation and

the underlying disease.

A unique collaboration between Cole Eye Institute special-

ists and Orthopaedic & Rheumatologic Institute rheuma-

tologists at Cleveland Clinic provides timely, accurate diag-

nosis; prompt intervention; careful monitoring of systemic

treatment; and optimal outcomes for these patients.

The following case studies show the need for a high index

of suspicion for systemic disease among patients presenting

with ocular inflammation.

CASE 1: conjUnctivAL growth, photophobiA, bLUrreD vision

A 46-year-old man was referred to Cole Eye Institute

uveitis specialist Careen Lowder, MD, PhD, for evaluation

of a conjunctival growth in the left eye. He reported a

four-month history of intermittent photophobia, redness

and bilateral blurred vision. Over the last three to four

weeks, his left eye had become more injected and painful,

and a growth had developed.

Visual acuity was 20/25 in the right eye and 20/50 in the

left. The conjunctiva of both eyes was noticeably injected,

the left eye worse than the right. The redness was not

blanched with 2.5% topical phenylephrine.

In the left eye, the temporal conjunctiva was slightly

thickened with areas of capillary nonperfusion and scleral

necrosis. A white infiltrate in the temporal periphery of

the cornea was associated with thinning and ulceration. Ke-

ratic precipitates on the corneal endothelium and 2+ cells

in the anterior chamber were observed. In the right eye, sec-

tions of the sclera appeared to have a bluish-violet hue. The

dilated fundus examination was normal in both eyes.

Necrotizing scleritis and peripheral ulcerative keratitis, visu-

ally threatening conditions likely to be associated with an

autoimmune disorder, were diagnosed. IV methylpredniso-

lone 1g was given for three days, followed by prednisone

80 mg/day.

The patient’s ESR was 85, the CBC and serum creatinine

were normal, and a urinalysis showed trace protein but

no blood. Serological testing was strongly positive for pro-

teinase-3 cytoplasmic staining antineutrophil cytoplasmic

antibodies (PR3-cANCA).

A chest CT revealed faint bilateral infiltrates believed to be

early inflammation rather than scarring. Wegener’s granu-

lomatosis (WG) was suspected, and the patient was referred

to Carol A. Langford, MD, in Cleveland Clinic’s Center for

Vasculitis Care and Research.

slit lamp images of

the left eye. the pupil

was dilated with 2.5%

topical phenylephrine.

A: Areas of avascular or

necrotic sclera (arrows).

b: peripheral corneal

infiltration with thinning

and ulceration (arrow).

A B


Due to the severity of his scleritis, cyclophosphamide

175 mg/day and trimethoprim sulfamethoxazole were

added to his glucocorticoids. His ocular inflammation

significantly improved within five days.

After three months, the patient’s ocular disease was

in remission, and a repeat chest CT showed that pulmo-

nary findings had resolved, supporting their inflamma-

tory nature and further confirming a systemic illness

consistent with WG. The patient was then switched from

cyclophosphamide to azathioprine, and a prednisone

taper was continued. The patient continues to be followed

jointly and remains in remission.

CASE 2: pAinFUL, reDDeneD eyes, heADAche, sUDDen heAring Loss

A 56-year-old man was referred to Dr. Careen Lowder at

Cole Eye Institute with painful, reddened eyes, headaches

and photophobia. He was diagnosed with bilateral scleritis

and was started on topical steroid eye drops. His initial

evaluation revealed a positive PR3-cANCA.

The positive ANCA, combined with an awareness of

associated systemic diseases, prompted a referral to

Rula Hajj-Ali, MD, in the Center for Vasculitis Treatment

and Research.

A review of symptoms and evaluation were negative

for Wegener’s granulomatosis (WG) and other systemic

inflammatory diseases. However, the patient’s scleritis

became resistant to local treatment, and he was started

on methotrexate to control the inflammation.

His scleritis responded well, and he continued methotrex-

ate for two years. The patient then elected to discontinue

methotrexate and opted for close follow-up.

Three years later, his scleritis recurred. A review of

systems revealed sudden bilateral hearing loss and

bloody sinus discharge. A diagnosis of WG was con-

firmed and Dr. Hajj-Ali restarted systemic treatment,

with a favorable response.

This case illustrates an often-forgotten fact: Ocular

inflammation may be the presenting manifestation of

a systemic disease, sometimes preceding its onset by

several years.

CASE 3: FLoAters, reDUceD vision, AbDoMinAL tenDerness

A 35-year-old woman presented with f loaters and

decreased vision to Dr. Careen Lowder at Cole Eye

Institute. The patient had bilateral iritis and vitritis

complicated by macular edema.

Following an initial laboratory evaluation to rule out

infectious processes, her macular edema was treated with

intraocular steroid injections. Her uveitis became recur-

rent, and she was closely followed both by rheumatologist

Dr. Rula Hajj-Ali and by Dr. Lowder.

During follow-up, her course was complicated by new-onset

joint pain, weight loss and abdominal discomfort. She also

started to develop a rash over her lower extremities.

On exam, Dr. Hajj-Ali found the patient to have mild

abdominal tenderness over the right lower quadrant and

a few tender nodules over her lower extremities consistent

with erythema nodosum.

Inflammatory bowel disease was suspected as the etiology

of this patient’s uveitis and systemic symptoms. Uveitis is

frequently associated with IBD and many other systemic

diseases, including sarcoidosis, multiple sclerosis, Behçet’s

disease and the seronegative spondyloarthropathies.

A workup confirmed the diagnosis of Crohn’s disease.

The patient was referred to Cleveland Clinic’s Digestive

Disease Institute for confirmatory tests and management

recommendations.

ABOuT the AUthors

Dr. Careen Lowder specializes in ocular inflammatory

diseases and uveitis. She has been joined at Cole Eye Insti-

tute by another uveitis specialist, Sunil Srivastava, MD,

who is also a vitreoretinal surgeon.

Dr. Rula Hajj-Ali specializes in uveitis in the Center

for Vasculitis Care and Research, which Dr. Carol Langford

directs.

Contact Dr. Lowder or Dr. Srivastava at

[email protected].

*Adapted from Werdich XQ, Lowder CY, Singh AD. Necrotizing scleritis.

Advanced Ocular Care. May/June 2010; 1(4): 25-6. (Bryn Mawr Com-

munications LLC)

Uveitis is frequently

associated with

inflammatory bowel

disease and systemic

diseases such as sar-

coidosis, multiple scle-

rosis, Behçet’s disease

and the seronegative

spondyloarthropathies.


Research Seeks to Elucidate the Causes of Acute Retinal Necrosis

Sunil Srivastava, MD

Acute retinal necrosis (ARN) is a rare condition that can result in significant

visual disability, most often due to retinal detachment. However, the

cause of ARN has never been fully described. Sunil Srivastava, MD, the

newest retina specialist at Cleveland Clinic’s Cole Eye Institute, has been

interested in ARN for years and is actively studying its origins.

retinal whitening and hemorrhages in

the peripheral retina are characteristic

of acute retinal necrosis.


“If we could identify patients who are most susceptible to experiencing this type of infection,

we could treat them earlier and for a longer duration.” – Sunil Srivastava, MD

“we are pretty sure the herpes simplex virus is in-

volved, as well as the varicella-zoster virus,” he says.

“however, we also suspect there are genetic traits that

make patients more susceptible to having it become

active in their eye. we know that immunocompro-

mised patients experience worse outcomes than

those with healthier immune systems.”

Dr. srivastava is analyzing blood samples from

patients with Arn in collaboration with stephanie A.

hagstrom, phD, to look for genetic variations related to

the immune system. he is also working to develop an

animal model of Arn.

Link to herpes encephALitis

he suspects the existence of an immune system link

because Arn is frequently seen in patients who have

herpes encephalitis. “studies show that children who

have herpes encephalitis have a genetic trait that makes

it hard for them to fight the encephalitis,” explains Dr.

srivastava.

Also, he says, since the vast majority of the population

has been exposed to the herpes virus by adulthood, the

distribution of individuals who actually develop Arn is

unlikely to be purely random.

“some of the explanation for why the virus remains

latent in many people while others develop a severe

ocular infection undoubtedly has something to do with

where the virus has ‘hidden’ in the body. patients

with Arn probably have latent virus in the nerve cells

in the head or neck region,” he says.

“but that is still not enough of an explanation. there

may be small mutations that cause deficiencies in

the immune system that dictate outcomes.”

Most Arn sufferers, who typically present with hazy

vision, red eye and ocular pain, are otherwise healthy.

Arn occurs in patients ranging in age from teenagers to

the elderly, but it is most common in middle age.

gOAL: eArLier, Longer treAtMent

“if we could identify patients who are most susceptible

to experiencing this type of infection, we could treat

them earlier and for a longer duration,” he says.

treatment for Arn typically includes antiviral medica-

tions such as acyclovir and valacyclovir as well as anti-

inflammatories. A vitrectomy or other surgical options

are primarily indicated if there is a retinal detachment.

Dr. srivastava hopes that since the herpes virus is so

prevalent in the general population, his research may

lead to improvements in treating it throughout the body.

he joined the cole eye institute from emory University

in Atlanta earlier this year, where he completed his

residency. Dr. srivastava completed a fellowship in

vitreoretinal surgery at Duke University Medical center

and a fellowship in uveitis and medical retina at the

national institutes of health.

contact Dr. sunil srivastava


retinal photograph

illustrates acute retinal

necrosis involving the

majority of the retina.

white regions represent

areas of active infection.

BASIC RESEARCH FUNDING


Cleveland Clinic Cole Eye Institute had an aggregate annual grant level of $9,323,757 in 2009-2010, with $4,109,754 coming from federal sources.

Title Source Sponsor iD investigator Amount

inhibition of VEgF-Mediated Angiogenesis Federal nih cA106415 Bela Anand-Apte, MBBS, phD $265,215

role of TiMp-3 in Ocular neovascularization Federal nih ey016490 Bela Anand-Apte, MBBS, phD $331,022

Age-related Changes in Epithelial Microvilli Federal nih ey07153 Vera Bonilha, phD $424,875

proteomic Biomarkers for primary Open Angle glaucoma

Federal nih ey014239 John W. Crabb, phD $196,250

role of TuLp1 in photoreceptor Cells Federal nih ey016072 Stephanie Hagstrom, phD $270,035

initiating Events in AMD: An Animal Model for the Human Disease

Federal (2009-2010)

nih r56 ey014240 Joe G. Hollyfield, PhD $368,250


Federal (2010-2011)

nih ey014240 Joe G. Hollyfield, PhD $368,250


Federal nih ey014240 Joe G. Hollyfield, PhD $323,623

Chair grant for the Comparison of AMD Treatment Trials (CATT)

Federal nih ey017828 Daniel Martin, MD $52,008

Administrative Supplement to Chair grant for the Comparison of AMD Treatment Trials (CATT)


Chair grant for the Comparison of AMD Treatment Trials (CATT)


Mechanisms of Synaptic Transmission in the retina

FederalAlbert einstein Medical college

ey010254 neal S. peachey, phD $27,095

retinal iron Homeostasis in Health and Disease

FederalMedical college of georgia

ey019672 neal S. peachey, phD $42,475

Corneal Epithelial growth Factors and receptors

Federal nih ey010056 Steven E. Wilson, MD $367,500

rpB Lew Wasserman Award otherresearch to prevent blindness

Bela Anand-Apte, MBBS, phD $60,000

Identification of Biomarkers other ruth & Milton steinbach Foundation

John W. Crabb, phD $300,000

role of TuLp1 in photoreceptor Protein Trafficking

other hope for vision Stephanie Hagstrom, phD $50,000

Sybil B. Harrington Scholar Award otherresearch to prevent blindness

Stephanie Hagstrom, phD $55,000

Study of retinal Degenerative Diseases (FFB Center grant)

otherFoundation Fighting blindness

cMM-0707-0407 cMM-0707-0408 cMM-0707-0409 cMM-0707-0410

Joe G. Hollyfield, PhD John W. Crabb, phD Stephanie Hagstrom, phD neal S. peachey, phD

$2,090,018

Study of retinal Degenerative Disease otherMacula vision research Foundation

Joe G. Hollyfield, PhD $240,000


Wolf Family Award other wolf Foundation Joe G. Hollyfield, PhD $100,000

rpB unrestricted grant otherresearch to prevent blindness

Daniel Martin, MD $200,000

Electrical Activity of the Mouse retinal pigment Epithelium

other neal S. peachey, phD $400,000

Electrophysiological Markers other neal S. peachey, phD $316,433

The role of Complement regulation in Maintaining Outer retinal integrity

otherAmerican health Assistance Foundation

neal S. peachey, phD $100,000

Title Source Sponsor iD investigator Amount

NEI Grant Focuses on Corneal HealingSteven E. Wilson, MD, cleveland clinic ophthalmologist, has been awarded a $2 million national

eye institute grant to study corneal epithelial growth factors and healing. Dr. wilson, Director of

corneal research at cole eye institute, says the study will focus on intracellular communication

within the cornea to elucidate the regulation of healing after injury, infection or surgery.

his other research interests include gene delivery to human cells using viral vectors, wound healing,

and cytokines and receptors in tissues in the eye, as well as research into the mechanisms of dry eye

and clinical research into corneal shape and corneal diseases.

Dr. wilson specializes in laser refractive procedures (LAsik/prk) and corneal surgery (penetrating keratoplasty and DsAek), and is

a leading expert in dry eye and ocular surface diseases. he is listed in Best Doctors in America (2004-2010) and has won numerous

awards. he is a former trustee and vice president of the Association for research in vision and ophthalmology (Arvo), the largest

vision research organization in the world, and is currently north American councilor for the international society for eye research.

retinal Disease

A phase ii Dose ranging Study of pazopanib to Treat neovascular Age-related Macular Degeneration (gSK AMD)

Objective: the purpose of this study is to determine the safety and efficacy of different dosage regimens of pazopanib eye drops for the treatment of neovascular age-related macular degeneration.

Contact: Andrew p. schachat, MD, 216.444.7963, or Laura holody, 216.445.3762

retinal Vein Occlusion Fluocinolone Acetonide intravitreal inserts for Vein Occlusion in retina (FAVOr)

Objective: this study will assess the safety and efficacy of fluocinolone acetonide intravitreal inserts in subjects with macular edema secondary to retinal vein occlusion.

Contact: peter k. kaiser, MD, 216.444.6702, or gail kolin, rn, 216.445.4086

Macular Edema incidence/Severity reduction with nevanac® (MiZAr)

Objective: the purpose of this study is to determine the safety and efficacy of Nevanac for the prevention of macular edema in patients with diabetic retinopathy within 90 days following cataract surgery.

Contact: rishi p. singh, MD, 216.445.9497, or gail kolin, rn, 216.445.4086

genetic Eye Disease

Corneal Shape and Biomechanics in the Diagnosis of Marfan Syndrome

Objective: this study will examine the corneal biomechanical properties of individuals with Marfan syndrome.

Contact: william j. Dupps jr., MD, phD, 216.444.8396, or Laura holody, 216.445.3762

Studies of the Molecular genetics of Eye Diseases (BrTT)

Objective: the objective of this project is to study the molecular genetics of ophthalmic disorders through the compilation of a collection of DnA,

plasma and eye tissue samples from patients and from families with a broad range of eye diseases and malformations.

Contact: elias i. traboulsi, MD, 216.444.4363, or emma Lessieur, 216.445.9886

Cornea and External Diseases

Donor preparation pressure and refractive Shift in Descemet Stripping Automated Endothelial Keratoplasty (DSAEK)

Objective: the purpose of this study is to determine if the infusion pressure used during DsAek (Descemet stripping automated endothelial keratoplasty) donor tissue preparation affects postoperative graft morphology, refractive outcome and graft endothelial cell count in the recipient.

Contact: william j. Dupps jr., MD, phD, 216.444.8396

Safety and Effectiveness of the VEgA uV-A System for Corneal Collagen Cross-Linking in Eyes with Keratoconus (X-Linking)

Objective: the purpose of this research study is to test the safety, tolerability and effectiveness of corneal collagen cross-linking (cxL) when used to treat keratoconus.

Contact: ronald r. krueger, MD, Mse, 216.444.8158, or Fadiah Al khawaldeh, 216.445.3641

Other studies

Safety Study of a Single iVT injection of Qpi-1007 in Chronic Optic nerve Atrophy and recent Onset nAiOn patients (nAiOn)

Objective: in this open-label, dose escalation, safety, tolerability and pharmacokinetic study, active study drug (Qpi-1007) will be given to all participating patients. this study will determine whether Qpi-1007 is safe when injected into the eye, and will reveal any side effects of the drug and how long it takes for the body to clear the drug.

Contact: rishi p. singh, MD, 216.445.9497, or Laura holody, 216.445.2264

in Follow-upthe following studies have completed enrollment and are in follow-up at cole eye institute:

A phase ii Multicenter, prospective, randomized, comparator controlled, Dose ranging study evaluating pF-04523655 versus ranibizumab in the treatment of subjects with choroidal neovascularization (Monet)

A Clinical Safety and Efficacy Comparison of nevanac® 0.1% to vehicle Following cataract surgery in Diabetic retinopathy patients (nevAnAc)

A randomized, Double-Masked, sham-controlled Phase III Study of the Efficacy, Safety and tolerability of repeated intravitreal Administra-tion of vegF trap-eye in subjects with Macular edema secondary to central retinal vein occlusion (vegF trap crvo)

An open-Label, Multicenter extension study to evaluate the safety and tolerability of ranibizumab in subjects with Macular edema secondary to retinal vein occlusion who have completed a genentech sponsored ranibi-zumab study (horizon 2)

A 24-Month randomized, Double-Masked, controlled, Multicenter, phase iiib study Assessing Safety and Efficacy of Verteporfin (Visudyne®) photodynamic therapy Administered in conjunction with ranibizumab (Lucentis™) versus ranibizumab (Lucentis™) Monotherapy in patients with subfoveal choroidal neovascularization secondary to Age-related Macular Degeneration (DenALi)

A phase iii, Double-Masked, Multicenter, randomized, sham-controlled study of the Efficacy and Safety of Ranibizumab Injection in Subjects with Clinically Significant Macular Edema with center involvement secondary to Diabetes Mellitus (DMe)

An eight-week, Multicenter, Masked, randomized Trial to Assess the Safety and Efficacy of 700 μg and 350 μg Dexamethasone Posterior Segment Drug Delivery system

Applicator system compared with sham Dex ps DDs Applicator system in the treatment of Non-Infectious Ocular Inflammation of the posterior segment in patients with intermediate Uveitis (posUrDex Uveitis)

CLiniCAL TRIAlSAll studies have been approved by the Institutional Review Board. Highlighted studies are currently enrolling.



DISTINGUISHED lECTURE SEriES

March 17, 2011

Functionalizing Cell-Based Therapy

for Age-related Macular Degeneration

Marco A. zarbin, MD, phD

Alfonse A. cinotti, MD/Lions eye

research professor and chair,

institute of ophthalmology and

visual science,

new jersey Medical school,

University of Medicine & Dentistry

of new jersey

newark, n.j.

April 21, 2011

Age-related Macular Degeneration:

Any More genes Left to Find?

bernhard weber, phD

professor, institute of human genetics,

University of regensburg

regensburg, germany

May 19, 2011

The Biology of Latent infection

With Herpes Simplex Virus

todd p. Margolis, MD, phD

Foundation Director and Director, ralph

and sophie heintz research Laboratory,

Francis i. proctor Foundation

professor of ophthalmology,

University of california, san Francisco

san Francisco, calif.

June 16, 2011

Building a Focused research group:

glaucoma research at Devers Eye institute

George A. Cioffi, MD

chairman, Devers eye institute,

senior vice president and chief

Medical Officer, Legacy Health,

professor of ophthalmology,

oregon health & science University

portland, ore.

July 21, 2011

High-resolution imaging in patients

With inherited retinal Degenerations

jacque L. Duncan, MD

professor of clinical ophthalmology,

beckman vision center,

University of california, san Francisco,

school of Medicine

san Francisco, calif.

Sept. 15, 2011

DnA repair in retinal Degenerations

jeffrey h. boatright, phD

Associate professor of ophthalmology,

research (basic science) section,

emory University school of Medicine

Atlanta, ga.

Oct. 20, 2011

ironing Out the role of Oxidative Stress

in Age-related Macular Degeneration

joshua L. Dunaief, MD, phD

Assistant professor of ophthalmology,

F.M. kirby center for Molecular

ophthalmology,

scheie eye institute,

University of pennsylvania school of

Medicine

philadelphia, pa.

nov. 17, 2011

Emerging Human Adenoviruses:

A Systems Biology Approach to predicting

the next Eye pathogen

james chodosh, MD, Mph

Lecturer in ophthalmology,

harvard Medical school

Massachusetts Eye & Ear Infirmary

boston, Mass.

the Distinguished Lecture series is held

from 7 to 8 a.m. in the james p. storer

Conference Center on the first floor of

cleveland clinic’s cole eye institute. no

registration is required, and we will validate

your parking ticket. call Laura hogan at

216.444.5832 with any questions.

Cleveland Clinic’s Cole Eye Institute is proud to present the 2011 Distinguished lecture Series, which provides a forum for internationally renowned researchers in the visual sciences to present their latest findings on basic and clinical ophthalmic research. Ample opportunity for questions and answers is provided after lectures.


CME OppORTUNITIES & GRAND ROUNDS

cole eye institute cMe Mark your calendars for continuing medical education symposia

hosted by cole eye institute. you’ll gain insights into state-of-the-art

diagnostic, medical and surgical techniques as well as the promise

that research holds for patients with ophthalmic conditions.

uveitis update

saturday, April 9, 2011

Activity Director: careen y. Lowder, MD, phD

north Coast retina Symposium ii

Friday-saturday, May 13-14, 2011

Activity Director: Daniel F. Martin, MD

Annual research, residents & Alumni Meeting

Friday, june 17, 2011

Activity Director: elias i. traboulsi, MD

An optical coherence tomography Update is tentatively scheduled

for july 2011.

cMe symposia are held in the james p. storer conference cen-

ter on the first floor of Cleveland Clinic’s Cole Eye Institute unless

otherwise indicated. For further details or updates and for parking

information, please contact jane sardelle at 216.444.2010 or

800.223.2273, ext. 42010, or at [email protected].

cole eye institute grand rounds ophthalmologists from other institutions are welcome to attend cole

eye institute grand rounds, held Mondays from 7 to 8 a.m. through-

out the academic year, except during holidays and major meetings.

each session features two cases that represent outstanding teaching

examples, followed by extensive discussion. cases may feature rare

or difficult-to-manage conditions, unusual presentations of common

disorders, and/or state-of-the-art diagnosis and management. three

to four M&M cases are presented each year.

category 1 continuing education credits are offered. grand rounds,

held in the james p. storer conference center at cole eye institute,

are videoconferenced weekly to cleveland clinic ophthalmology

(Lakeland eye) in Lorain, ohio, and monthly to Lv prasad institute

in hyderabad, india. no registration is required. For details and

parking vouchers, please contact jane sardelle at [email protected].

Ophthalmology Update, a publication of cleveland clinic’s cole eye institute, provides information for ophthalmologists about state-of-the-art diagnostic and management techniques and current research.

please direct any correspondence to:

steven e. wilson, MD cole eye institute / i32 the cleveland clinic Foundation 9500 euclid Ave. cleveland, oh 44195

phone 216.444.5887 Fax 216.445.8475

institute Chairman Daniel F. Martin, MD

Editor-in-Chief steven e. wilson, MD

Managing Editor cora Liderbach

Art Director Michael viars

Marketing Manager bill sattin, phD

Marketing Associate natalie weigl, rn

the cleveland clinic Foundation is an independent, not-for-profit, multispecialty academic medical center. It is dedicated to providing quality specialized care and includes an outpa-tient clinic, a hospital with more than 1,000 available beds, an education division and a research institute.

Ophthalmology Update is written for physicians and should be relied upon for medical education purposes only. it does not provide a complete overview of the topics covered and should not replace the independent judgment of a physician about the appropriateness or risks of a procedure for a given patient. physicians who wish to share this information with patients need to make them aware of any risks or potential complica-tions associated with any procedures.

© the cleveland clinic Foundation 2011

COlE EyE INSTITUTE STAFF

Chairman, Cole Eye institute

Daniel F. Martin, MD ...........................................216.444.0430

Comprehensive Ophthalmology

richard e. gans, MD ............................................216.444.0848

philip n. goldberg, MD ......................................... 216.831.0120

Martin A. Markowitz, MD .....................................440.461.4733

shari Martyn, MD ................................................ 216.831.0120

Michael e. Millstein, MD ...................................... 216.831.0120

sheldon M. oberfeld, MD ....................................440.461.4733

Allen s. roth, MD ................................................ 216.831.0120

David b. sholiton, MD .......................................... 216.831.0120

scott A. wagenberg, MD .....................................440.461.4733

Cornea and External Diseases

william j. Dupps jr., MD, phD ..............................216.444.8396

roger h.s. Langston, MD .....................................216.444.5898

Martin A. Markowitz, MD ......................................440.461.4733

David M. Meisler, MD ........................................... 216.444.8102

sheldon M. oberfeld, MD .....................................440.461.4733

Allen s. roth, MD ................................................ 216.831.0120

scott A. wagenberg, MD ......................................440.461.4733

steven e. wilson, MD ...........................................216.444.5887

glaucoma

jonathan A. eisengart, MD ....................................216.445.9429

edward j. rockwood, MD ..................................... 216.444.1995

Keratorefractive Surgery

william j. Dupps jr., MD, phD ..............................216.444.8396

gregory s. kosmorsky, Do ....................................216.444.2855

ronald r. krueger, MD, Mse ................................ 216.444.8158

Michael e. Millstein, MD ....................................... 216.831.0120

Allen s. roth, MD ................................................ 216.831.0120

steven e. wilson, MD ...........................................216.444.5887

neuro-Ophthalmology

gregory s. kosmorsky, Do ....................................216.444.2855

Lisa D. Lystad, MD...............................................216.445.2530

Oculoplastics and Orbital Surgery

julian D. perry, MD ..............................................216.444.3635

Ophthalmic Anesthesia

Marc A. Feldman, MD ..........................................216.444.9088

Ophthalmic Oncology

Arun D. singh, MD ............................................... 216.445.9479

Ophthalmic research

bela Anand-Apte, Mbbs, phD ............................... 216.445.9739

john w. crabb, phD .............................................216.445.0425

Joe G. Hollyfield, PhD ..........................................216.445.3252

neal s. peachey, phD ........................................... 216.445.1942

pediatric Ophthalmology and Adult Strabismus

Andreas Marcotty, MD .......................................... 216.831.0120

paul rychwalski, MD ............................................216.444.4821

elias i. traboulsi, MD ...........................................216.444.4363

retina

justis p. ehlers, MD ............................................. 216.636.0183

Froncie A. gutman, MD ........................................216.444.5888

peter k. kaiser, MD ..............................................216.444.6702

Daniel F. Martin, MD ............................................216.444.0430

Andrew p. schachat, MD ......................................216.444.7963

jonathan e. sears, MD ......................................... 216.444.8157

rishi p. singh, MD ............................................... 216.445.9497

sunil srivastava, MD ............................................216.636.2286

uveitis

careen y. Lowder, MD, phD ..................................216.444.3642

sunil srivastava, MD ............................................216.636.2286


pATIENT rEFErrALSto refer a patient to the cole eye institute, please call 216.444.2020 or 800.223.2273, ext 42020.

cole eye institute

the cleveland clinic Foundation

9500 euclid Avenue / Ac311

cleveland, oh 44195

Ophthalmology Update

physician resource guidereFerrALs

216.444.2020 or 800.223.2273, ext. 42020

the cleveland clinic cole eye institute vision Line is your direct link for prompt physician referrals to an ophthalmology subspecialist for consultation and appointments.

reFerring physiciAn center

For help with service-related issues, information about our clinical specialists and services, details about cMe opportunities, and more, contact the referring physician center at [email protected], or 216.448.0900 or 888.637.0568.

trAck yoUr pAtient’s cAre onLine

DrConnect offers referring physicians secure access to their patients’ treatment progress while at cleveland clinic. to receive your next patient report electroni-cally, establish a DrConnect account at clevelandclinic.org/drconnect.

reQUest MeDicAL recorDs

216.444.2640 or 800.225.2273, ext. 42640

oUtcoMes DAtA

view clinical outcomes books from cole eye institute and other cleveland clinic institutes at clevelandclinic.org/quality/outcomes.

cleveland clinic cMeHealthcare Quality innovation Summit

May 11-13, 2011

Optimizing Value & Securing a Future of Innovation

and Quality

the cleveland clinic healthcare Quality innovation summit

is devoted to exploring novel strategies for improving the

assessment and delivery of quality healthcare. this multidis-

ciplinary conference brings together the major stakeholders

in this process for in-depth discussions of the shared and

sometimes competing visions through which health quality

metrics can be used to advance healthcare outcomes.

For details and to register online, visit ccfcme.com/Quality11.

patient Experience Summit

May 22-24, 2011

Transforming Healthcare Through Empathy and Innovation

this unique summit will provide insights and solutions to

transform the patient experience. the 2010 patient experience

summit initiated a global discussion of patient experience and

what it means to the future of healthcare. this year’s event

will feature presentations, debate and candid discussion of

key patient experience issues that are essential to the future of

healthcare delivery, but also applicable to any discipline where

excellent customer service is the key to success.

For details and to register, visit empathyandinnovation.com.

Both events will be held at the InterContinental Hotel &

Conference Center on Cleveland Clinic’s main campus.

Other Cleveland Clinic CME Opportunities

cleveland clinic’s center for continuing education operates one

of the country’s largest and most successful cMe programs.

visit ccfcme.com to find live and online CME in 29 specialties,

a virtual textbook of medicine, a daily medical newsfeed, and

mycMe to help you manage your cMe portfolio. Most cMe

courses are held in cleveland, but outreach plans are under

way. in 2010, the center offered 11 simultaneous courses at

Arab health, a major world healthcare forum in Dubai, United

Arab emirates.

90 Years Logo4 color process

Blue: 100/34/0/2Green: 100/0/85/24

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