Session Title: FP-15 Vascular Diseases and Diabetic Retinopathy V
Session Date/Time: Sunday 14/09/2014 | 08:00-10:00
Paper Time: 08:40
Venue: Boulevard D
First Author: : K.Lorenz GERMANY
Co Author(s): :
Sister trials COPERNICUS and GALILEO were undertaken to evaluate the efficacy and safety of IVT-AFL for the treatment of macular oedema secondary to CRVO. The current analysis examines the impact of IVT-AFL on patient-reported visual function using the 25-item National Eye Institute Visual Function Questionnaire (NEI VFQ-25) through 24 and 52 weeks in patients with macular oedema secondary to CRVO.
Two Phase 3, randomised, multicentre, double-masked trials in 123 sites in 15 countries.
In both studies, patients with macular oedema secondary to CRVO with central retinal thickness (CRT) ≥250 μm and ETDRS best-corrected visual acuity (BCVA) of 20/40 to 20/320 were randomised (3:2) to receive IVT-AFL 2 mg (IVT-AFL 2q4) or sham monthly for 24 weeks. The primary endpoint was the proportion of patients who gained ≥15 ETDRS letters in BCVA from baseline to Week 24. From Week 24 onward in COPERNICUS both IVT-AFL 2q4- and sham-treated patients were eligible to receive IVT-AFL 2 mg based on visual and anatomical outcomes (IVT-AFL 2q4+PRN, sham+IVT-AFL PRN), while in GALILEO, sham-treated patients received sham treatment until Week 52. In both studies, monthly monitoring was performed until Week 52. The studies continued through Week 100 (COPERNICUS) and Week 76 (GALILEO). Total and subscale scores for the NEI VFQ-25, which was administered at baseline and at Weeks 24 and 52, were compared between the IVT-AFL 2q4+PRN, sham, and sham+IVT-AFL PRN treatment groups. 24-week data were integrated, while 52-week data were analysed separately by study. In total, 307 patients (COPERNICUS [n=164]; GALILEO [n=143]) completed 52 weeks of treatment.
Mean NEI VFQ-25 total scores were similar for the treatment groups at baseline (integrated IVT-AFL 2q4+PRN = 78.7, integrated sham = 78.3), as were baseline scores for near vision activities, distance vision activities, and dependency. Mean change from baseline to Week 24 in NEI VFQ-25 total score was greater in the integrated IVT-AFL 2q4+PRN group than the integrated sham group (7.3 vs 2.2). Likewise, mean changes from baseline to Week 24 were greater in the integrated IVT-AFL 2q4+PRN group compared with the integrated sham group for near vision activities (9.3 vs 1.7), distance activities (6.2 vs 1.0), and dependency (5.5 vs 1.8). In both studies, the mean change from baseline to Week 52 in NEI VFQ-25 total score was greater in the IVT-AFL 2q4+PRN groups (7.8 in COPERNICUS and 7.5 in GALILEO, respectively) than in the sham+IVT-AFL PRN or sham groups (4.5 in COPERNICUS and 5.1 in GALILEO, respectively). In both studies, mean changes from baseline to Week 52 were greater in the IVT-AFL 2q4+PRN than the sham and sham+IVT-AFL PRN groups for near activities, distance activities, and dependency. In all treatment groups in both studies, the greatest improvements were seen in subscale scores for near vision activities.
Patients in the IVT-AFL 2q4+PRN treatment group experienced clinically meaningful improvements (typically defined in the literature as an increase of 4–6 points) from baseline to Week 24 and baseline to Week 52 in NEI VFQ-25 total score and in subscale scores for near vision activities, distance activities, and dependency. Changes with IVT-AFL 2q4+PRN were greater than those seen in both the sham and sham+IVT-AFL PRN treatment groups.