AdvANCEs iN MANAgEMENT Of ChOROidAl MElANOMAsSince 2007, Dr. Brian Berger has operated on more than 30 patients diagnosed with choroidal melanoma. Recently, Dr. Berger has employed a new prognostic test developed by William Harbour, MD that evalu-ates the genetic profile of choroidal melanomas and predicts the likelihood of metastasis in the next five years with 99 percent accuracy.
During surgery, a fine needle aspirate biopsy (FNAB) is performed either transscleraly for an-terior tumors or transvit-really for posterior tumors. A tumor tissue sample is sent to a laboratory for evaluation, and the tumor is classified as: Class 1, less than 1 percent chance of metas-tasis within five years, or Class 2, high risk of metastasis and only 25 percent survival rate by five years. This new prognostic tool equips Dr. Berger with additional insight into the nature of the tumor and allows him and the oncologist to create a more customized treat-ment plan for their patients.
Dr. Brian Berger is the first and only physician to perform FNAB on choroidal melanomas in Austin, TX. The first biopsy was performed on April 25, 2011, and he has
Left: Marking the tumor margins using transillumination. Right: Placement of the new Eye Physics plaque.
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Outcome of metastasis and disease-associated survival of the predicted low-risk (Class 1) and the high-risk (Class 2) molecular signatures from 228 subjects. Data obtained from the most recent collection point, November 2009, of the five-year follow-up study.
RRC Offers Three Trials to Patients with dry Age-Related Macular degenerationThe Retina Research Center gives patients the opportunity to participate in clinical trials and provides them with the greatest variety of treatment options for numer-ous eye diseases. AREDS vitamins have been the only proven treatment to slow the progression of dry age-related macular degeneration (ARMD) since 2001. RRC has teamed up with Pfizer and Genentech to evaluate new, cutting-edge treatments for ARMD.
Pfizer is sponsoring a first in human trial evaluating safety, immunogenicity, and tolerability of multiple escalating doses of RN6G, a humanized monoclonal antibody directed against amyloid-beta in subjects with advanced ARMD. Geographic atrophy is the main cause for loss of vision in patients with ARMD. Genentech is evaluating the safety, tolerability, and efficacy of FCFD4514S, an antigen-binding fragment of a humanized antibody directed against complement component factor D, when injected intravitreally into patients with geographic atrophy.
We are also looking forward to working with GlaxoSmithKline in the near future to investigate the safety, efficacy, and pharmacokinetics of GSK933776, a humanized IgG1 monoclonal antibody directed against the N-terminal amino acid residues 1-7 of amyloid-beta, in adults with geographic atrophy secondary to ARMD.
Mahalo/CFD4870g (Genentech) trial. The key inclusion criteria:�� Geographic atrophy secondary to ARMD in the absence of choroidal neovas-
cularization in both eyes�� Age 60–89 years�� BCVA 20/50–20/400 in the study eye�� Cannot have a history of wet ARMD or diabetic retinopathy in either eye�� Cannot have a history of vitrectomy surgery, submacular surgery, or other
surgical intervention for ARMD in the study eye
Currently enrolling patients! Please contact Kristen Davis at [email protected] or call 512-279-1252 (Kristen’s direct line).
B1181002 (Pfizer) trial. The key inclusion criteria:�� Dry ARMD with drusen and/or geographic atrophy in the study eye�� Age 60–85 years�� BCVA 20/80 or better in the study eye�� ≥ 40kg but ≤ 100kg�� Cannot use any drugs with platelet antiaggregant or anticoagulant properties
Enrollment for Cohort 2 will start at the end of August. Please contact Ivana Gunderson at [email protected] or call 512-279-1251 (Ivana’s direct line).
GlaxoSmithKline BAM114341 trial. The key inclusion criteria:�� Dry ARMD in both eyes with at least one druse in either eye and well-
demarcated geographic atrophy in the study eye�� Must be able to get an MRI�� Cannot use any drugs with platelet antiaggregant or anticoagulant properties
(aspirin ≤ 325mg/day is acceptable)�� Age ≥ 55 years�� BCVA 20/80 or better in the study eye
Coming soon! For more information, please contact Ivana Gunderson at [email protected] or call 512-279-1251 (Ivana’s direct line).
�� Iconic Therapeutics IT-001—A Phase IA multi-center, open-label study of hI-con1 administered intravitreally to subjects with exudative age-related macular degeneration.
�� Alcon RACE C-09-067—A Phase IIA trial evaluating AL-78898A, an inhib-itor of complement component C3, versus Lucentis in treatment of naïve patients with wet macular degeneration.
�� GSK MD7114987—An open-label, Phase IIA study to evaluate pazopanib eye drops administered for 12 weeks to patients with neovascular age-related macular degeneration.
�� Lpath LT1009-Oph-002—A Phase IB study of iSONEP by intravitreal injection to patients with pigment epithelial detach-ment (PED) secondary to wet age-related macular degeneration.
dry Age-Related Macular degeneration
�� Pfizer B1181102—A Phase I trial evaluating the safety, immu-nogenicity, and tolerability of multiple, ascending intravenous (IV) dosages of RN6G (monoclonal antibody binding amyloid beta).
�� Genentech CFD4870g—A Phase IB/II trial evaluating the safety and tolerability of FCFD4514S administered by intra-vitreal injection monthly or every other month in patients with geographic atrophy.
�� GlaxoSmithKline BAM114341—A Phase II trial evaluating the safety, tol-erability, efficacy, pharmacodynamics and pharmacokinetics of GSK933776 in adult patients with geographic atrophy secondary to ARMD.
Uveitis
�� Abbott M10-877, M10-880, M10-327—A Phase III trial evaluating the ef-ficacy and safety of Adalimumab (Humira) 80mg loading dose followed by a 40mg dose given every other week for the treatment of noninfectious active and quiescent posterior and intermediate uveitis.
�� Lux Biosciences LX211-11—A Phase III trial evaluating the efficacy and safety of LX211 (Luveniq) in patients with active noninfectious uveitis of the intermediate or posterior segments of the eye.
diabetic Macular Edema
�� DRCR Network Protocols—A trial to compare time and spectral domain in patients with diabetic macular edema.
Trials aT round rockWe are pleased to announce that we are now enrolling patients into the following three trials at our Round Rock location:
�� Lux Biosciences LX211-11
�� DRCR Protocol M
�� Alcon RACE C-09-067
More to come!
PREsENTATiONs & PUBliCATiONs
Brian B. Berger, MD
�� Presentation: “DARPin® MP0112 Shows Extended VEGF Inhibition Effect in DME,” to be presented at The Retina Society 2011 Conference, Rome, Italy; September 2011.
�� Publication: “Fluocinolone Implant for Idiopathic Non-Infectious Posterior Uveitis,” Retinal Physician 8(7), September 2011.
Brian B. Berger, MD
new Guidelines for screeninG for Plaquenil reTinal ToxiciTy The American Academy of Ophthalmology has recently changed the recommendations for screening eye exams for Plaquenil retinal toxicity. The new guidelines include autofluorescence fundus imaging and spectral domain optical coherence tomography scanning of the macula. Both of these tests are available at both of our offices for patients that need to be screened for Plaquenil retinal toxicity.
Farewell and best wishes to Dr. Robert Wong in
his new venture.
www.ret inaresearchcenter .com
4 Retina Research Center News
AllERgAN ACqUiREs ExClUsivE RighTs TO MP0112The Retina Research Center was one of five sites in the nation to participate in the Phase I MP0112 DARPin® trial evaluating the efficacy of MP0112, a small thera-peutic protein, on endothelial growth factor A (VEGF-A) in patients with diabetic macular edema. A similar Phase I/IIA trial took place in Europe concurrently and evaluated the efficacy of MP0112 in patients with age-related macular degenera-tion. Allergan Inc. and Molecular Partners entered into a license agreement for MP0112 on May 4, 2011 where Allergan will obtain exclusive right for MP0112 for ophthalmic indications. The data from the Phase I/IIA trials was presented in Fort Lauderdale, FL, at the May meeting of the Association for Research in Vision and Ophthalmology (ARVO). The data indicated that after a single injec-tion, MP0112 was well tolerated and visual acuity remained stable with modest improvement throughout the 12-week study. Dr. Brian Berger will present this data to the Retina Society in Italy at the end of the summer. Molecular Partners and Al-lergan will work together on the Phase IIB trial, REACH, and we look forward to participating in the further development of MP0112. feaTured emPloyees
We would like to congratulate Kristen Davis and LaToya Perez on the new additions to their families. Kristen gave birth to her first child, Randolph Jett Davis III, on June 28. Kristen has been a research coordinator at the Retina Research Center since 2008. She is currently a coordinator for all of the DRCR network trials, Alcon RACE, Lux Biosciences LX211-01, and Genentech CFD4870g.
LaToya also gave birth to her first child, Christian Anthony Perez Jr., on July 12. LaToya is a patient account specialist at Brian B. Berger, MD, PA and has been with the company since 2009.
completed two more since then. An accurate genetic profile was obtained in each case.
After the biopsy, the melanoma is treated with an Iodine-125 episcleral plaque, designed by radiation oncologist Stephen Brown, MD and his team. Plaque design has also advanced. Dr. Berger and Dr. Brown use the Eye Physics design versus the original COMS plaque, which Dr. Berger was trained to use while participating in the COMS study (1986–1998). Eye Physics plaques are thinner and therefore physically closer to the eye. Reducing the distance between the I-125 seeds and tumor apex is advantageous since the dose to the adjacent eye structures is reduced. During surgery, Dr. Berger sutures the radioactive plaque over the underlying melanoma. To complete the procedure, Dr. Berger combines a vitrectomy with silicone oil injection to reduce collateral radiation damage to vital ocular structures, as demonstrated by Tara McCannel, MD.
AdvANCEs iN MANAgEMENT Of ChOROidAl MElANOMAs
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LaToya Perez
Kristen Davis
Left: Computer modeling showing Eye Physics plaque superimposed on model eye with anatomically correct placement of tumor photo collage. Right: Computerized
treatment simulation showing radiation Isodose lines superimposed on tumor.
