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S. S. Patel, Macugen in CRVO Study Group; Pegaptanib Sodium for the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO): Anatomical Outcomes. Invest. Ophthalmol. Vis. Sci. 2007;48(13):311.
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© ARVO (1962-2015); The Authors (2016-present)
To assess the safety and efficacy of pegaptanib in treating macular edema secondary to CRVO in a phase 2 trial.
A prospective, multicenter, double-masked, sham-controlled, dose-finding trial enrolled subjects with CRVO of ≤6 months duration. Required were best-correct visual acuity in the study eye of 65 to 20 ETDRS letters inclusive and central retinal thickness at the center point of ≥250 µm at baseline and first treatment day (determined by optical coherence tomography [OCT]). Subjects were randomized (1:1:1) to intravitreous pegaptanib sodium (0.3 mg, 1 mg) or sham injections every 6 weeks for 24 weeks; follow-up continued through 52 weeks. Panretinal photocoagulation for neovascularization was permitted according to the Central Vein Occlusion Study protocol. OCT was performed at weeks 6, 12, 30, 40, and 52. Endpoints at week 52 included mean changes from baseline in thickness at the center point and at the central subfield and percentages of subjects developing retinal or iris neovascularization.
Included were 98 subjects (0.3 mg and 1 mg, n=33; sham, n=32), of whom 52 were men; overall mean age at baseline was 61.8 years. Mean baseline thickness was relatively well balanced (0.3 mg, 687 µm; 1 mg, 642 µm; 674 µm, sham). At week 52, mean change from baseline in thickness at the center point was -295 µm, -216 µm, and -183 µm for the 0.3 mg, 1 mg, and sham groups, respectively, and at the central subfield was -291 µm, -210 µm, and -168 µm, respectively (P<0.05 for 0.3 mg vs sham). In all, 9%, 6%, and 9%, respectively developed retinal or iris neovascularization. No significant change in any group was noted in capillary nonperfusion for central subfield, inner subfields, or outer subfields.
Treatment of macular edema due to CRVO with pegaptanib seems to provide anatomical benefits compared to sham. Further studies are needed to confirm selective VEGF inhibition as a therapeutic option for this unmet medical condition.
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