Anti-VEGF well tolerated for treating neovascular AMD in year 3 of VISION trial

Br J Ophthalmol. 2008;92:1636-1641.

Pegaptanib sodium was well tolerated in the third year of testing in patients with neovascular age-related macular degeneration.

In years 1 and 2 of the VISION (VEGF inhibition study in ocular neovascularization) trial, Macugen (pegaptanib sodium, OSI/Pfizer) was well tolerated, which continued into year 3. Also in year 3, serious adverse events, such as rhegmatogenous retinal detachment, iatrogenic traumatic cataracts and endophthalmitis, were infrequent, and other adverse events tended to be ocular in nature, mild, transient and injection-related.

There was no evidence of systemic safety signals related to vascular endothelial growth factor inhibition and no findings related to vital signs or electrocardiogram results suggesting a relationship to pegaptanib treatment, according to the study.

In the first year, two concurrent, prospective, multicenter, double-masked studies randomized patients to receive 0.3 mg, 1 mg or 3 mg of intravitreous pegaptanib sodium or sham injections every 6 weeks for 54 weeks. After this, subjects who initially received pegaptanib were re-randomized to continue or discontinue the treatment for another 48 weeks, while sham-treated subjects were re-randomized to continue sham therapy, begin pegaptanib therapy or discontinue therapy.

At 102 weeks, patients who received pegaptanib 0.3 mg or 1 mg in years 1 or 2 continued with this treatment, while those who received pegaptanib 3 mg or who did not receive treatment in years 1 and 2 were re-randomized to 0.3 mg or 1 mg. There was no sham group in the study's third year.