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J. J. Wroblewski, J. A. Wells, C. Gonzales, W. Clark, S. D. Schwartz; Open Label Pegaptanib for the Treatment of Macular Edema Secondary to Branch Retinal Vein Occlusion (BRVO). Invest. Ophthalmol. Vis. Sci. 2007;48(13):310.
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Phase II data has demonstrated Pegaptanib to be safe and efficacious for the treatment of diabetic macular edema and macular edema related to central retinal vein occlusion. We hypothesize that macular edema secondary to BRVO is mediated by vascular endothelial growth factor (VEGF 165) and that chronic suppression of VEGf 165 will successfully treat BRVO related macular edema.The primary study objective is to determine the effect of Pegaptanib on best-corrected visual acuity, using Early Treatment of Diabetic Retinopathy Study (ETDRS) visual acuity measurement, in eyes with macular edema secondary to BRVO.The secondary study objectives are:1. To determine the effect on macular edema using optical coherence tomography (OCT)2. To determine the effect on retinal vascular leakage and perfusion using fluorescein angiography (FA)3. To determine ocular safety parameters
Prospective, open label, multicenter, clinical trial enrolling 30 patients with BRVO greater than one month old but less than six months old. Best corrected ETDRS visual acuity 20/40 - 20/320. Central foveal thickness > 250 microns. Intravitreous injections of Pegaptanib 0.3 mg or 1.0 mg given at baseline, week 6 and week 12 with subsequent injections at six weekly intervals at the discretion of the investigator until week 54.
13 patients have been enrolled and received at least one injection. At week one, 12 of 13 eyes have gained 5 or more ETDRS letters and 8 of these 13 eyes have gained 10 or more ETDRS letters. 5 of 6 eyes that have reached week 25 have gained 12 or more ETDRS letters. Reduction in OCT central subfield and center point thickness occurred in all 13 eyes at week one. The mean baseline center point thickness of 510 microns was reduced to 283 microns at week one. However, degree of foveal thinning did not precisely correlate with visual acuity gains. No adverse ocular events have occurred.
Intravitreal Pegaptanib appears to invoke resolution of macular edema one week following each injection. Foveal thinning correlated with visual acuity gains in most eyes. Pegaptanib appears to be safe in eyes with BRVO.
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