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David M. Brown, Julia A. Haller, David S. Boyer, Jeffrey S. Heier, W. L. Clark, Alyson J. Berliner, Robert Vitti, Oliver Zeitz, Rupert Sandbrink; Intravitreal Aflibercept Injection in Central Retinal Vein Occlusion: 1-year Results of the Phase 3 COPERNICUS Study. Invest. Ophthalmol. Vis. Sci. 2012;53(14):936.
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To assess the efficacy and safety of intravitreal aflibercept injection (IAI) in patients with macular edema secondary to central retinal vein occlusion (CRVO).
This was a randomized, double-masked, Phase 3 study in which patients received 6 monthly injections of either 2 mg IAI (VEGF Trap-Eye; 114 patients) or sham injections (73 patients). From Week 24 to Week 52, all patients received 2 mg IAI as-needed (PRN) according to retreatment criteria. The primary endpoint was the proportion of patients who gained ≥15 ETDRS letters from baseline at Week 24. Additional secondary visual, anatomic, and Quality of Life NEI VFQ-25 outcomes at Weeks 24 and 52 were also evaluated.
At Week 24, the primary endpoint showed a statistically significant difference between the two groups: 56.1% of IAI patients gained ≥15 ETDRS letters from baseline vs 12.3% of sham patients (P<0.0001). Similarly, at Week 52, 55.3% of IAI/IAI PRN patients gained ≥15 letters vs 30.1% of sham/IAI PRN patients (P<0.01). At Week 52, IAI/IAI PRN patients gained a mean of 16.2 letters of vision vs 3.8 letters for sham/IAI PRN (P<0.001). Mean number of injections was 2.7 for IAI/IAI PRN vs 3.9 for sham/IAI PRN. Mean change in central retinal thickness was -413.0 µm for IAI/IAI PRN vs -381.8 µm for sham/IAI PRN. Proportion of patients with ocular neovascularization at Week 24 were 0% for IAI patients and 6.8% for sham patients, respectively; at Week 52 after receiving IAI PRN, the proportions were 0% and 6.8% for IAI/IAI PRN and sham/IAI PRN patients. At Week 24, the mean change from baseline in the VFQ-25 total score was 7.2 vs 0.7 for the IAI and sham groups; at Week 52, the scores were 7.5 vs 5.1 for the IAI/IAI PRN and sham/IAI PRN groups. Most common adverse events among all patients were conjunctival hemorrhage, visual acuity reduced, and eye pain.
Monthly dosing with 2 mg intravitreal aflibercept injection in patients with macular edema secondary to CRVO resulted in a statistically significant improvement in visual acuity at Week 24 that was maintained through Week 52 with PRN dosing compared with control sham/IAI PRN treatment. Intravitreal aflibercept injection was generally well tolerated and had a generally favorable safety profile.
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