Purchase this article with an account.
Julia A. Haller, David S. Boyer, Jeffrey S. Heier, David M. Brown, Lloyd Clark, Robert Vitti; VEGF Trap-Eye In CRVO: Primary Endpoint Results Of The Phase 3 COPERNICUS Study. Invest. Ophthalmol. Vis. Sci. 2011;52(14):6643.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
VEGF Trap-Eye is an intravitreally administered fusion protein that is designed to bind the pro-angiogenic factors VEGF-A and placental growth factor with higher affinity than their natural receptors. This study evaluated the efficacy and safety of VEGF Trap-Eye in patients with macular edema secondary to central retinal vein occlusion (CRVO) after 24 weeks of treatment.
In this randomized, double-masked, controlled Phase 3 study, 114 patients received 6 monthly injections of 2 mg VEGF Trap-Eye and 73 patients received control sham injections. Visual acuity was measured as a score based on the total number of Early Treatment of Diabetic Retinopathy Study (ETDRS) letters read correctly. The primary endpoint was the proportion of patients who gained at least 15 ETDRS letters from baseline at 24 weeks. A key secondary endpoint was the mean change in best-corrected visual acuity from baseline at 24 weeks.
The primary endpoint was met in this study: 56.1% of patients receiving 2 mg VEGF Trap-Eye monthly gained at least 15 letters of vision from baseline, compared with 12.3% of patients receiving sham injections (p<0.0001). Patients receiving VEGF Trap-Eye gained a mean of 17.3 letters of vision compared with a mean loss of 4.0 letters with sham injection (p<0.001). The most common adverse events were those typically associated with intravitreal injections and/or the underlying disease. The proportions of patients who experienced serious ocular adverse events were 3.5% in the VEGF Trap-Eye group and 13.5% in the sham group. The incidence of non-ocular serious adverse events was generally well balanced between the treatment and sham groups.
Dosing monthly with 2 mg VEGF Trap-Eye in patients with macular edema secondary to CRVO resulted in a statistically significant improvement in visual acuity compared with control sham treatment. VEGF Trap-Eye was generally well tolerated and had a generally favorable safety profile.
Clinical Trial: :
This PDF is available to Subscribers Only