| Title | Pegaptanib sodium for macular edema secondary to central retinal vein occlusion. | | Author(s) | Wroblewski JJ, Wells JA, Adamis AP, Buggage RR, Cunningham ET, Goldbaum M, Guyer DR, Katz B, Altaweel MM, Pegaptanib in Central Retinal Vein Occlusion Study Group | | Institution | Cumberland Valley Retina Consultants, Hagerstown, Maryland 21740, USA. johnw@retinacare.net | | Source | Arch Ophthalmol 2009 Apr; 127(4):374-80. | | MeSH | Angiogenesis Inhibitors
Aptamers, Nucleotide
Double-Blind Method
Female
Fluorescein Angiography
Humans
Injections
Macular Edema
Male
Middle Aged
Retinal Vein Occlusion
Tonometry, Ocular
Vascular Endothelial Growth Factor A
Visual Acuity
Vitreous Body
| | Abstract | 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 microm and 210 microm, respectively, vs 5 microm 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: clinicaltrials.gov Identifier: NCT00088283. | | Language | eng | | Pub Type(s) | Clinical Trial, Phase II
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't
| | PubMed ID | 19365011 |
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