Objectives: To assess the safety and efficacy of intra- vitreous pegaptanib sodium for the treatment of macular edema following central retinal vein occlusion (CRVO). Design: This dose-ranging, double-masked, multi- center, phase 2 trial included subjects with CRVO for 6 months' or less duration randomly assigned (1:1:1) to receive pegaptanib sodium or sham injections every 6 weeks for 24 weeks (0.3 mg and 1 mg, n = 33; sham, n = 32). Main Outcome Measure: Visual acuity at week 30. Results: In the primary analysis at week 30, 12 of 33 (36%) subjects treated with 0.3 mg of pegaptanib sodium and 13 of 33 (39%) treated with 1 mg gained 15 or more letters from baseline vs 9 of 32 (28%) sham- treated subjects (P =.48 for 0.3 mg and P =.35 for 1 mg of pegaptanib sodium vs sham). In secondary analyses, subjects treated with pegaptanib sodium were less likely to lose 15 or more letters (9% and 6%; 0.3-mg and 1-mg pegaptanib sodium groups, respectively) compared with sham-treated eyes (31%; P = .03 for 0.3 mg and P = .01 for 1 mg of pegaptanib sodium vs sham) and showed greater improvement in mean visual acuity ( + 7.1 and +9.9, respectively, vs -3.2 letters with sham; P=.09 for 0.3 mg and P = .02 for 1 mg of pegaptanib sodium vs sham). By week 1, the mean central retinal thickness decreased in the 0.3-mg and 1-mg pegaptanib sodium groups by 269 μm and 210 μm, respectively, vs 5 μm with sham (P< .001). Conclusions: Based on this 30-week study, intravitre- ous pegaptanib sodium appears to provide visual and anatomical benefits in the treatment of macular edema following CRVO.
ASJC Scopus subject areas