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Xiao-Yan Li, Srinivas Sadda, Ronald P. Danis, Jenny Jiao, Scott M. Whitcup; Retinal Vascular Changes Following Treatment With Dexamethasone Intravitreal Implant (DEX Implant) in Patients With Macular Edema (ME) Secondary to Branch or Central Retinal Vein Occlusion (RVO). Invest. Ophthalmol. Vis. Sci. 2011;52(14):1259.
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To report the angiographic findings from trials that evaluated the safety and efficacy of DEX implant for the treatment of ME due to branch or central RVO.
Two identical, double-masked, sham-controlled, 6-month trials randomized ME patients with RVO to receive either DEX implant 0.7 mg (n = 427), DEX implant 0.35 mg (n = 414), or sham procedure (n = 426). Eligible DEX implant or sham patients (BCVA of < 84 letters or retinal thickness of > 250 µm) received DEX implant 0.7 mg at day 180 and were followed in an open-label, 6-month, extension study. Fluorescein angiography (FA) was performed at baseline and months 6 and 12. Here we report the pooled analysis of FA findings for the DEX implant 0.7 mg and sham groups at baseline and month 6 from 55 study sites, which submitted their FA images to the Doheny Image Reading Center for a masked evaluation.
FA images from 166 DEX implant 0.7 mg patients and 163 sham patients were centrally evaluated. At baseline, neovascularization (NV) was observed in 12/151 (7.9%) DEX implant patients and 16/157 (10.2%) sham patients. At day 180, active NV was present in 11/146 (7.5%) DEX implant patients and 23/142 (16.2%) sham patients. Global nonperfusion could only be assessed in < 60% of patients at baseline, primarily due to extensive hemorrhage but was gradable at day 180 in 136/149 (91.3%) DEX implant patients and 119/146 (81.5%) sham patients, with mean nonperfusion of 5.9 MPS DA and 5.1 MPS DA, respectively. Only 26/123 (21.1%) DEX implant patients and 19/104 (18.3%) sham patients had nonperfusion ≥ 10 MPS DA at day 180. Severe foveal nonperfusion was present in 25/157 (15.9%) DEX implant patients and 21/160 (13.1%) sham patients.
DEX implant patients appeared to have less neovascularization compared to sham patients. Extensive capillary nonperfusion and neovascularization were relatively uncommon, consistent with enrollment criteria. No angiographic safety concerns were observed.
http://www.clinicaltrials.gov 00168298, 00168324
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