Topcon Endpoint Management

Exclusion Criteria

• •Eyes with scatter photocoagulation (PRP) one month prior the enrollment, or eyes where scatter photocoagulation is required now, or it likely to be needed over the next 6months (for example, eyes with high risk PDR DRS not properly treated with photocoagulation).
• •Presence of any abnormality that is likely to confound the assessment of the improvement in visual acuity in eyes with macular edema to resolve or improve as an area of hard exudates involving the foveal avascular zone (FAZ - involving 2 or more quadrants centered around the foveal avascular zone), epiretinal membrane associated with signs of contraction and / or significant opacification (ie, striations within the diameter of a disc from the center of the fovea), or the presence of chorioretinal atrophy involving the center of the macula.
• •Vitreomacular traction determined clinically and / or OCT, which in the opinion of the investigator, contributes to macular edema (associated or cause a detachment of the fovea) and prevents the improvement with treatment.
• •Any cause of macular edema other than DME.
• •Atrophy / scar / fibrosis involving the center of the macula, including evidence of atrophy treated with laser within 200 microns of the FAZ.
• •Patients who received panphotocoagulation, YAG laser, or peripheral retinal cryoablation (for retinal tears) or focal or grid photocoagulation within the last 12 weeks or more of treatment with focal or grid laser.
• •Significant opacities of the optical medium, including cataracts, which may interfere with visual acuity, assessment of toxicity or photography background. Patients will not be included if they have high probability of requiring cataract surgery within the next year.
• •Any intraocular surgery within 6 months prior to study entry.
• •Prior peeling of epiretinal membrane or inner limiting membrane.
• •Any major surgical procedure within one month of study entry
• •Prior irradiation of the head region of the eye under study.
• •Any previous pharmacological treatment for DME (including corticosteroid intravitreal, subconjunctival or subtenon) or at any time during the last 90 days for any other condition.
• •Important known allergies to sodium fluorescein dye used in angiography.
• •Acute ocular or periocular infection.