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Pegaptanib shows efficacy in macular edema secondary to CRVO
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NEW ORLEANS — Administering intravitreal pegaptanib sodium injections appears safe and effective in treating macular edema after central retinal vein occlusion, according to a speaker here.
At the American Academy of Ophthalmology annual meeting, Thomas A. Ciulla, MD, presented the 1-year results of a prospective phase 2 study being conducted by the Pegaptanib in Central Retinal Vein Occlusion (CRVO) Study Group, which is investigating the efficacy of Macugen (pegaptanib sodium, Eyetech/Pfizer) in the treatment of macular edema secondary to CRVO.
"Selective VEGF blockade seems to be a promising approach to the treatment of retinal vascular disease," Dr. Ciulla said.
The study enrolled 98 patients from 36 centers who had had CRVO for 6 months or less. Specifically, 33 patients in group one were randomly assigned to receive 0.3-mg injections of pegaptanib, 33 patients in group two received 1-mg injections of pegaptanib and 32 patients in group three received sham injections. All groups received treatment every 6 weeks for 30 weeks.
At week 30, 36% of patients in group one, 39% of patients in group two and 26% of patients in group three had an improvement in visual acuity of 15 or more letters. In addition, 9% of group one patients, 6% of group two patients and 31% of group three patients had lost 15 or more letters.
"If we look at the OCT data, we can see the mean change in thickness at the central point, and we can see that there's an improvement in all the groups, but in the Macugen-treated groups, [there's] a much more robust improvement," Dr. Ciulla said. "This change occurs very early, within the first 6 weeks."
Specifically, 68% of group one patients, 63% of group two patients and 10% of group three patients had a decrease in central retinal thickness of 100 µm or more.
After 42 weeks, patients were eligible for re-treatment based on a 15-letter loss in visual acuity, Dr. Ciulla said. Eight patients in group one, seven patients in group two and two patients in group three required additional treatment. The mean number of additional treatments for the pegaptanib-treated patients was 1.5.