Pegaptanib sodium for macular edema secondary to central retinal vein occlusion.

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.

• Authors: John J Wroblewski, John A Wells 3rd, Anthony P Adamis, Ronald R Buggage, Emmett T Cunningham Jr, Mauro Goldbaum, David R Guyer, Barrett Katz, Michael M Altaweel, Pegaptanib in Central Retinal Vein Occlusion Study Group
• Journal: Archives of ophthalmology (Chicago, Ill. : 1960) (Arch Ophthalmol) Vol. 127 Issue 4 Pg. 374-80 (Apr 2009) ISSN: 1538-3601 [Electronic] United States
• PMID: 19365011 (Publication Type: Clinical Trial, Phase II, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Angiogenesis Inhibitors
• Aptamers, Nucleotide
• Vascular Endothelial Growth Factor A
• pegaptanib

Topics

• Angiogenesis Inhibitors (administration & dosage, adverse effects)
• Aptamers, Nucleotide (administration & dosage, adverse effects)
• Double-Blind Method
• Female
• Fluorescein Angiography
• Humans
• Injections
• Macular Edema (drug therapy, etiology)
• Male
• Middle Aged
• Retinal Vein Occlusion (complications, drug therapy)
• Tonometry, Ocular
• Vascular Endothelial Growth Factor A (metabolism)
• Visual Acuity
• Vitreous Body