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J. J. Wroblewski, J. A. Wells, III, C. Gonzales; Pegaptanib Sodium for Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO). Invest. Ophthalmol. Vis. Sci. 2008;49(13):2718.
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To present a final analysis of a study evaluating the efficacy and safety of pegaptanib for the treatment of macular edema secondary to BRVO.
This prospective, double-masked, uncontrolled, dose-finding study included patients with BRVO that occurred >1 month but <6 months with baseline best-corrected visual acuity (VA) between 70 and 25 letters inclusive (≈20/40 - 20/320) and central foveal thickness (OCT) ≥250 µm. Patients were randomized (1:1) to pegaptanib 0.3 or 1 mg injections for up to 54 weeks. Patients were treated at 6 weekly intervals for 12 weeks (3 injections) followed by additional injections as needed per the investigators’ discretion. Laser photocoagulation was allowed for neovascularization.
20 patients (20 eyes) have been enrolled and will be followed up for 52 wks. At 30 weeks, a mean of 5.2 injections was administered. Baseline mean VA was 56 letters (~20/80), mean center point thickness was 489 µm and mean macular volume was 10.0 mm3. One week after the first injection mean VA improved by 11 letters, mean center point thickness improved by 210 µm, and mean macular volume improved by 2.0 mm3. At week 30 mean visual acuity, center point thickness, and macular volume improved by 13 letters, 225 µm, and 2.3 mm3, respectively. Gains of ≥0, 5, 10, and 15 letters at week 1 were seen in 94%, 76%, 47%, and 18% of the 17 eyes evaluated; and at week 30 in 85%, 75%, 65%, and 50% of the 20 eyes evaluated. Two eyes did not require additional injection therapy beyond week 12. Absolute decreases from baseline in center point thickness of ≥0, 100, and 200 µm at week 1 were seen in 100%, 76%, and 76% of patients; and at week 30 in 95%, 85%, and 65%. No serious adverse ocular events have occurred.
Selective VEGF inhibition with pegaptanib may provide visual and anatomical benefits in BRVO. Larger randomized clinical trials are needed to confirm this hypothesis.
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