Retinal Physician

JAN-FEB 2017

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62 R E T I N A L P H Y S I C I A N . C O M | N O V E M B E R / D E C E M B E R 2 0 1 6 62 CLINICAL TRIAL UPDATE R E T I N A L P H Y S I C I A N | J A N U A R Y / F E B R U A R Y 2 0 1 7 disease, neovascular glaucoma, etc.) Information: www.jaeb.org Study: Phase II Combination Steroid and Anti-VEGF for Persistent DME Sponsor: Jaeb Center for Health Research Purpose: To assess the short-term effects of combination steroid+anti-VEGF therapy on visual acuity and retinal thickness on OCT in comparison with that of continued anti-VEGF therapy alone in eyes with persistent central- involved DME and visual acuity impairment despite previous anti-VEGF treatment Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind Number of Patients: 125 Inclusion Criteria: At least three injections of anti-VEGF drug (ranibizumab, bevacizumab, or aflibercept) within the prior 20 weeks; visual acuity letter score in study eye ≤ 78 and ≥24 (approximate Snellen equivalent 20/32 to 20/320); on clinical exam, definite retinal thickening due to DME involving the center of the macula; OCT CSF thickness, within 8 days of enrollment: i) On Zeiss Cirrus ≥ 290 microns in women; ≥ 305 in men ii) On Heidelberg Spectralis: ≥ 305 microns in women; ≥ 320 in men Exclusion Criteria: Macular edema is considered to be due to a cause other than DME. An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/or OCT suggest that vitreoretinal interface abnormalities (e.g., a taut posterior hyaloid or epiretinal membrane) are the primary cause of the macular edema; an ocular condition is present such that, in the opinion of the investigator, visual acuity loss would not improve from resolution of macular edema (e.g., foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, non-retinal condition, etc.); an ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, etc.) Information: www.jaeb.org pathologies that would interfere with vision Information: clinicaltrials@scifluor.com DIABETIC MACULAR EDEMA Study: Protocol V: Treatment for CI-DME in Eyes With Very Good VA Study Sponsor: Jaeb Center for Health Research Purpose: To compare the percentage of eyes that have lost at least 5 letters of visual acuity at 2 years compared with baseline mean visual acuity in eyes with central- involved DME and good visual acuity defined as a Snellen equivalent of 20/25 or better Design: Randomized, Safety/Efficacy, Parallel Assignment, Single-blind Number of Patients: 702 Inclusion Criteria: Best corrected E-ETDRS visual acuity letter score ≥ 79 (approximate Snellen equivalent 20/25 or better) at two consecutive visits within 1 to 28 days; on clinical exam, definite retinal thickening due to DME involving the center of the macula; diabetic macular edema confirmed on OCT (equivalent to CSF thickness on OCT ≥250 microns on Zeiss Stratus or gender-specific spectral domain OCT equivalent) at two consecutive visits within 1 to 28 days. (a) Investigator must verify accuracy of OCT scan by ensuring it is centered and of adequate quality Exclusion Criteria: Macular edema is considered to be due to a cause other than DME. a) An eye should not be considered eligible if: (1) the macular edema is considered to be related to ocular surgery such as cataract extraction or (2) clinical exam and/ or OCT suggest that vitreoretinal interface abnormalities (eg, a taut posterior hyaloid or epiretinal membrane) are contributing to the macular edema; an ocular condition is present such that, in the opinion of the investigator, any visual acuity loss would not improve from resolution of macular edema (eg, foveal atrophy, pigment abnormalities, dense subfoveal hard exudates, nonretinal condition); an ocular condition is present (other than DME) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (eg, vein occlusion, uveitis or other ocular inflammatory WET AMD Study: Safety and Exploratory Efficacy Study of SF0166 in the Treatment of Neovascular Age-Related Macular Degeneration Sponsor: SciFluor Life Sciences Purpose: To evaluate the safety and exploratory efficacy of SF0166 Topical Ophthalmic Solution in patients with Neovascular (wet) Age-related Macular Degeneration (AMD) Design: Randomized, Safety/Efficacy, Parallel Assignment, Double-blind Number of Patients: 40 Inclusion Criteria: Active subfoveal choroidal neovascularization due to Age- related Macular Degeneration (AMD) that meet the following criteria: total lesion ≤12 Macular Photocoagulation Study (MPS) disc areas; choroidal neovascularization (CNV) >50% of lesion area; intraretinal or subretinal fluid due to choroidal neovascularization (CNV) visible on optical coherence tomography (OCT) No atrophy or fibrosis involving the center of the fovea; best-corrected Visual Acuity (BCVA) of 0.3 to 1.2 Early Treatment Diabetic Retinopathy Study (ETDRS; Logarithmic minimum angle of resolution [logMAR]) in the study eye, with BCVA decrement primarily attributable to neovascular Age-related Macular Degeneration (AMD); treatment naïve (i.e., no previous anti-vascular endothelial growth factor [VEGF] treatment in the study eye) or previously treated study eye Exclusion Criteria: Fellow eye visual acuity (VA) worse than 1.3 Early Treatment Diabetic Retinopathy Study (ETDRS), Logarithmic minimum angle of resolution (logMAR) (ie, 35 letters equivalent); choroidal neovascularization (CNV) in the study eye secondary to other causes (eg., pathologic myopia, ocular histoplasmosis syndrome, angioid streaks, choroidal rupture, posterior uveitis, or multifocal choroiditis); previous macular laser photocoagulation or ocular photodynamic therapy in the study eye; media opacities or abnormalities that would preclude visualization of the retina; other retinal

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