The COPERNICUS Study (24-Week Results): VEGF Trap-Eye For The Treatment Of Macular Edema Secondary To Central Retinal Vein Occlusion

David Brown

Purpose: VEGF inhibition with the monoclonal antibody fragment ranibizumab has been shown to improve visual acuity in patients with macular edema secondary to central retinal vein occlusion (CRVO). VEGF Trap-Eye is an anti-angiogenic fusion protein that blocks all VEGF-A isoforms and placental growth factor. This study will evaluate the efficacy and safety of intravitreally administered VEGF Trap-Eye versus observation (sham administration) in patients with CRVO.

Methods: In this double-masked Phase 3 study, patients were randomized to intravitreal injection with VEGF Trap-Eye 2 mg or sham injection every 4 weeks for 24 weeks, followed by as-needed dosing based upon strict retreatment criteria. The primary efficacy endpoint was the proportion of patients with a gain of ≥15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. Secondary assessments include the mean change from baseline in BCVA by EDTRS score at 24 weeks.

Results: 24-week data will become available by early 2011. Efficacy and safety results will be presented and discussed.

Conclusion: The 24-week results of COPERNICUS will provide important information regarding the efficacy and safety of VEGF Trap-Eye for patients with macular edema secondary to CRVO.