THIRD-YEAR SAFETY RESULTS OF THE VISION TRIAL

Singerman et al report the safety data for patients who continued for 3 years in the VEGF Inhibition Study in Ocular Neovascularization (VISION) trial. Throughout the study, safety was assessed by adverse event reporting, ophthalmic examination, laboratory assessments, electrocardiograms (ECG), and vital signs. The primary safety population consisted of the 161 subjects who received at least one dose of study medication in year 3. Ocular adverse events occurred in 114/161 (71%) subjects and the majority of events were associated with the injection procedure. The most common ocular adverse events were punctate keratitis (25%), increased IOP (20%), eye pain (17%), and cataract (14%). There were two cases of endophthalmitis (0.06% per injection) and one case each of rhegmatogenous retinal detachment (0.03% per injection) and vitreous hemorrhage. There was no evidence of systemic side effects. The authors conclude that 3-year safety profile of pegaptanib sodium was favourable.

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SAME DAY VERTEPORFIN AND RANIBIZUMAB (PROTECT STUDY)

PROTECT is an open-label, multicentre, phase II study of the safety of ranibizumab administered on the same …