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J. A. Wells, III, J. J. Wroblewski, Macugen in CRVO Study Group; Pegaptanib Sodium for the Treatment of Macular Edema Following Central Retinal Vein Occlusion (CRVO): Functional Outcomes. Invest. Ophthalmol. Vis. Sci. 2007;48(13):1544.
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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-month duration. Required were best-correct visual acuity (VA) 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). 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. At week 52, endpoints included mean change in VA compared to baseline and percentages of subjects maintaining or gaining VA compared to baseline.
The trial included 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. The study eye was the right eye in 47% of the cases. Baseline mean VA was well balanced across study arms (~ 48 letters). At week 52, mean change in VA from baseline was +7.5, +6.3, and -2.4 letters in the pegaptanib 0.3 mg, 1 mg, and sham groups, respectively (P=ns). Compared to sham, fewer subjects treated with 0.3 mg pegaptanib (approved dose) lost ≥15 letters from baseline to week 52 (6% vs 31%, P<0.05), and more subjects treated with pegaptanib 0.3 mg than sham gained ≥0, 5, 10, and 15 letters of VA (76% vs 44%, P<0.05; 67% vs 38%; P<0.05; 52% vs 34%, ns; 33% vs 25%, ns).
Treatment of CRVO with pegaptanib may provide functional benefits compared to sham. This trial extends the potential of selective vascular endothelial growth factor blockade to the treatment of edema following CRVO from that similarly studied in diabetic macular edema.
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