Pegaptanib sodium for macular edema secondary to central retinal vein occlusion.
OBJECTIVE
To assess the safety and efficacy of intravitreous pegaptanib sodium for the treatment of macular edema following central retinal vein occlusion (CRVO).


METHODS
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).


METHODS
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.


CONCLUSIONS
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.


BACKGROUND
clinicaltrials.gov Identifier: NCT00088283.
Wroblewski
John J
JJ
Cumberland Valley Retina Consultants, Hagerstown, Maryland 21740, USA. johnw@retinacare.net
Wells
John A
JA
Adamis
Anthony P
AP
Buggage
Ronald R
RR
Cunningham
Emmett T
ET
Goldbaum
Mauro
M
Guyer
David R
DR
Katz
Barrett
B
Altaweel
Michael M
MM
D020533:Angiogenesis Inhibitors / Q000008:administration & dosage* / Q000009:adverse effects; D052157:Aptamers, Nucleotide / Q000008:administration & dosage* / Q000009:adverse effects; D004311:Double-Blind Method; D005260:Female; D005451:Fluorescein Angiography; D006801:Humans; D007267:Injections; D008269:Macular Edema / Q000188:drug therapy* / Q000209:etiology; D008297:Male; D008875:Middle Aged; D012170:Retinal Vein Occlusion / Q000150:complications / Q000188:drug therapy*; D014065:Tonometry, Ocular; D042461:Vascular Endothelial Growth Factor A / Q000378:metabolism; D014792:Visual Acuity; D014822:Vitreous Body
D020533:Angiogenesis Inhibitors; D052157:Aptamers, Nucleotide; D042461:Vascular Endothelial Growth Factor A; C495058:pegaptanib