ABSTRACT NUMBER - 2401

INTRAVITREAL VEGF TRAP-EYE IN CENTRAL RETINAL VEIN OCCLUSION: RESULTS OF THE PHASE 3 COPERNICUS AND GALILEO STUDIES


Mark Gillies

Meeting:  2012 RANZCO


SESSION INFORMATION

Date: 27 Nov 2012

Session Title: FREE PAPERS

Session Time: 2:00 pm - 3:30 pm

Purpose:
To assess vascular endothelial growth factor (VEGF) Trap-Eye (VTE, intravitreal aflibercept injec-tion) in patients with macular edema secondary to central retinal vein occlusion (CRVO).

Methods:
Patients were randomized to receive 2 mg VTE or sham every 4 weeks for 24 weeks. From Weeks 24–52, patients in GALILEO (n = 177) continued in their initial treatment groups, but received their allo-cated treatment as needed (PRN). All patients enrolled in COPERNICUS (n = 187) were treated with 2 mg VTE-PRN per retreatment criteria irrespective of the original allocation group.

Results:
At Week 52, in GALILEO, more VTE-treated patients gained ?15 ETDRS letters from baseline com-pared with sham (60.2% vs. 32.4%, P = 0.0004), with mean letter gains of 16.9 and 3.8, respectively (P < 0.0001). A larger mean decrease in central retinal thickness (CRT) was observed for VTE vs. sham treat-ment (?423.5 vs. ?219.3 ?m, P < 0.0001). In COPER-NICUS, more eyes injected with VTE+VTE-PRN gained ?15 letters than those receiving sham+VTE-PRN (55.3% vs. 30.1%, P < 0.001), with mean letter gains of 16.2 and 3.8, respectively (P < 0.001). Mean change in CRT was ?413.0 and ?381.8 ?m for VTE+VTE-PRN and sham+VTE-PRN, respectively. VTE treatment was generally well-tolerated. Conclusion: Patients treated with VTE for 52 weeks experienced considerable and sustained improvements in VA that were greater than those receiving sham or sham+VTE-PRN. Data from both studies suggest that VTE can be an effective treatment for macular edema secondary to CRVO.