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Phase 3 trials for novel anti-VEGF agent aim to confirm previous study results
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VANCOUVER, British Columbia — Parallel phase 3 trials will assess the safety and efficacy of a novel anti-VEGF agent believed to have a higher affinity for the VEGF-A isoform, a speaker said here.
 Murray J. Erasmus |
The VIEW-1 and VIEW-2 studies are phase 3 multicenter, randomized clinical trials evaluating VEGF Trap-Eye (Regeneron) in patients with wet age-related macular degeneration; 1,217 patients have been randomized in VIEW-1 and 1,240 in VIEW-2. In the trials, there are three active treatment groups with differing dosing strengths and frequencies, as well as a fourth group treated with current standard of care.
"VIEW 1 and VIEW-2 aim to confirm the findings in the phase 2 trials, and that is a significant and durable effect on visual acuity," Murray J. Erasmus, MD, said at the American Society of Retina Specialists annual meeting.
Previously, the CLEAR-IT phase 2 trial demonstrated a 7.3 letter gain after 3 months of fixed dosing with VEGF Trap-Eye, at which point patients were followed on as-needed therapy. Mean vision gain from baseline was 8.4 letters through 12 total months of study. An extension study using a 2-mg dose and as-needed therapy showed a 7.1 letter gain from baseline at 18 months and 6.1 letters at 24 months.