Clinical Trials
April 2009

Pegaptanib Sodium for Macular Edema Secondary to Central Retinal Vein Occlusion

Author Affiliations

Author Affiliations:Cumberland Valley Retina Consultants, Hagerstown, Maryland (Dr Wroblewski); Palmetto Retina Center, Columbia, South Carolina (Dr Wells); Jerini Ophthalmic Inc, New York, New York (Dr Adamis); Pfizer Inc, New York, New York (Dr Buggage); California Pacific Medical Center, San Francisco, and the Department of Ophthalmology, Stanford University School of Medicine, Stanford, California (Dr Cunningham); (OSI Pharmaceuticals) Eyetech Inc, New York, New York (Drs Goldbaum and Guyer); Fovea Pharmaceuticals Inc, New York, New York (Dr Katz); Department of Ophthalmology and Visual Sciences, University of Wisconsin School of Medicine and Public Health, Madison (Dr Altaweel).




Copyright 2009 American Medical Association. All Rights Reserved. Applicable FARS/DFARS Restrictions Apply to Government Use.2009

Arch Ophthalmol. 2009;127(4):374-380. doi:10.1001/archophthalmol.2009.14

Objectives  To assess the safety and efficacy of intravitreous pegaptanib sodium for the treatment of macular edema following central retinal vein occlusion (CRVO).

Design  This dose-ranging, double-masked, multicenter, 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, intravitreous pegaptanib sodium appears to provide visual and anatomical benefits in the treatment of macular edema following CRVO.

Application to Clinical Practice  Benefits accrued with intravitreous pegaptanib sodium treatment of macular edema following CRVO suggest a role for vascular endothelial growth factor in the pathogenesis of this condition.

Trial Registration Identifier: NCT00088283