DFA in DR is a relic of the past

Somdutt PrasadMS FRCSEd FRCOphth FACSsprasad@rcsed.ac.uk

AMRI and Fortis Hospitals, Kolkata 9830507754

DFA

Requires understanding of blockage and leakage

Does not delineate retinal morphology or thickness profile

DFA

Interpretation depends on interpretation of Dye Leakage Pooling Staining Axial location not possible

Invasive Time consuming

DFA - Safety

Nausea Allergic reactions Anaphylaxis

Yanuzzi et al – Ophthalmology – May 1986 (n=221,781) Moderate 1:63 Severe 1: 1900 Death 1: 222000

Pivotal Trials in DMEDRCR.NET PROTOCOL T

Study design: ranibizumab 0.3 mg in a PRN regimen

660 patients with DME randomized 1:1:1

2.0 mg intravitreal aflibercept(n = 224)

1.25 mg intravitreal bevacizumab (n = 218)

0.3 mg intravitreal ranibizumab (n = 218)

*A minimum of 21 days between visits

DRCR.net. August 2012. Available from: http://drcrnet.jaeb.org/Studies.aspx?RecID=206 [Accessed 27 October 2014]; Wells JA, et al. NEJM 2015, epub ahead of print

Visits every 4 ± 1 weeks* Treatment at baseline and thereafter using defined retreatment criteria

Year 1

Year 2Visits every 4 ± 1 weeks* as long as intravitreal injections are given

Otherwise, visits every 4-16 weeks

OCT, optical coherence tomography; PRN, pro re nata (as needed)

At or after Week 24, focal/grid laser will be initiated if OCT ≥250 μm or there is edema that is threatening the fovea and the eye has not improved on OCT or visual acuity from the last two consecutive injections†

Pivotal Trials in DMERESTORE STUDY

RESTORE Study - Inclusion

Visual acuity impairment Diabetic macular edema in at least

one eye Type 1 or type 2 diabetes mellitus Medication for the diabetes

treatment must be stable for the last 3 months

RESTORE Study - Exclusion

Patients with uncontrolled systemic or ocular diseases

Laser photocoagulation in the study eye for the last 3 months

Any history of any intraocular surgery in the study eye within the past 3 months

Blood pressure > 160/100 mmHg Extension Inclusion Criteria:

Completion of the Core Study

DFA or treat

OCT CSF = 358

VA 6/18

Hypertensive on treatment

DFA or treat

DFA or treat

DFA or treat

OCTA