PURPOSE: To assess the efficacy and safety of intravitreous pegaptanib sodium (Macugen; EyeTech Pharmaceuticals/Pfizer Inc, New York, New York, USA) for macular edema secondary to branch retinal vein occlusion (BRVO). DESIGN: Prospective, randomized, dose-finding study. METHODS:Twenty subjects from three clinical practices in the United States with BRVO of more than 1 month's and fewer than 6 months' duration; best-corrected visual acuity (BCVA) 70 to 25 Early Treatment Diabetic Retinopathy Study letters inclusive (approximately 20/40 to 20/320 Snellen); and central foveal thickness of 250 microm or more were included. Subjects were randomized 3:1 to intravitreous injections of pegaptanib 0.3 or 1 mg at baseline and at weeks 6 and 12 with subsequent injections at 6-week intervals at investigator discretion until week 48. Principal efficacy outcomes were change from baseline to week 54 in BCVA, center point thickness, central subfield thickness, and macular volume as measured by optical coherence tomography. RESULTS: Fifteen subjects received pegaptanib 0.3 mg and 5 received pegaptanib 1 mg. Eighteen subjects completed the 54-week follow-up. Results were similar in both the 0.3- and 1-mg groups. Overall improvements from baseline to week 54 occurred in mean BCVA (+14 +/- 13 letters), center point thickness (-205 +/- 195 mum), central subfield thickness (-201 +/- 153 mum), and macular volume (-2.2 +/- 1.6 mm(3)). The response was rapid after the first injection, with a mean BCVA improvement of 11 +/- 7 letters at 1 week from the baseline of 56 +/- 12 letters (approximately 20/80 Snellen). One retinal detachment and no cases of endophthalmitis or traumatic cataract were seen. CONCLUSIONS:Intravitreous pegaptanib offers a promising alternative as a treatment for macular edema secondary to BRVO. Copyright 2010 Elsevier Inc. All rights reserved.
RCT Entities:
PURPOSE: To assess the efficacy and safety of intravitreous pegaptanib sodium (Macugen; EyeTech Pharmaceuticals/Pfizer Inc, New York, New York, USA) for macular edema secondary to branch retinal vein occlusion (BRVO). DESIGN: Prospective, randomized, dose-finding study. METHODS: Twenty subjects from three clinical practices in the United States with BRVO of more than 1 month's and fewer than 6 months' duration; best-corrected visual acuity (BCVA) 70 to 25 Early Treatment Diabetic Retinopathy Study letters inclusive (approximately 20/40 to 20/320 Snellen); and central foveal thickness of 250 microm or more were included. Subjects were randomized 3:1 to intravitreous injections of pegaptanib 0.3 or 1 mg at baseline and at weeks 6 and 12 with subsequent injections at 6-week intervals at investigator discretion until week 48. Principal efficacy outcomes were change from baseline to week 54 in BCVA, center point thickness, central subfield thickness, and macular volume as measured by optical coherence tomography. RESULTS: Fifteen subjects received pegaptanib 0.3 mg and 5 received pegaptanib 1 mg. Eighteen subjects completed the 54-week follow-up. Results were similar in both the 0.3- and 1-mg groups. Overall improvements from baseline to week 54 occurred in mean BCVA (+14 +/- 13 letters), center point thickness (-205 +/- 195 mum), central subfield thickness (-201 +/- 153 mum), and macular volume (-2.2 +/- 1.6 mm(3)). The response was rapid after the first injection, with a mean BCVA improvement of 11 +/- 7 letters at 1 week from the baseline of 56 +/- 12 letters (approximately 20/80 Snellen). One retinal detachment and no cases of endophthalmitis or traumatic cataract were seen. CONCLUSIONS: Intravitreous pegaptanib offers a promising alternative as a treatment for macular edema secondary to BRVO. Copyright 2010 Elsevier Inc. All rights reserved.
Authors: Gesine B Jaissle; Peter Szurman; Nicolas Feltgen; Bernhard Spitzer; Amelie Pielen; Matus Rehak; Georg Spital; Heinrich Heimann; Carsten H Meyer Journal: Graefes Arch Clin Exp Ophthalmol Date: 2010-08-18 Impact factor: 3.117