Intravitrial Aflibercept Injection for Macular Edema in Central Retinal Vein Occlusion: 1-year Results of the Phase 3 GALILEO Study

Abstract

Purpose: : To evaluate the efficacy and safety of intravitreal aflibercept injection (IAI; also referred to as VEGF Trap-Eye ) in patients with macular edema secondary to central retinal vein occlusion (CRVO).

Methods: : In this double-masked, multi-center, controlled phase 3 study, 177 patients were randomized to 2 mg IAI or sham injections every 4 weeks. Beginning at Week 24 through week 52, patients in the IAI group were treated on an as-needed (PRN) basis with sham injections on non-treatment visits. Patients in the sham group continued to receive sham injections every 4 weeks. The primary endpoint was the proportion of patients who gained ≥15 ETDRS letters from baseline to Week 24. Secondary outcomes included the change from baseline in best-corrected visual acuity in ETDRS letters and the mean change in central retinal thickness (CRT).

Results: : At Week 52, 60.2 % of patients in the IAI group gained at least 15 ETDRS letters from baseline, compared with 32.4% of patients in the sham group (P = 0.0004). Patients receiving IAI gained a mean of 16.9 letters compared with a gain of 3.8 letters for patients receiving sham (P < 0.0001). Patients receiving IAI experienced a significantly larger mean decrease in CRT compared with patients receiving sham (-423.5 µm vs -219.3 µm; P < 0.0001). IAI was generally well tolerated; most common ocular adverse events were macular edema, increased intraocular pressure and eye pain.

Conclusions: : Patients treated with IAI experienced considerable and sustained improvements in visual acuity as compared to sham patients. The Week 52 results from the GALILEO study corroborate the results previously seen at Week 24 and are consistent with the results of the sister COPERNICUS study. Data obtained in both studies suggest that intravitreal aflibercept injection can be an effective treatment for macular edema secondary to CRVO.

Clinical Trial: : http://www.clinicaltrials.gov NCT01012973

Keywords: retina • injection • clinical (human) or epidemiologic studies: treatment/prevention assessment/controlled clinical trials