Abstract
Purpose:
The VIBRANT study was conducted to compare the efficacy and safety of IAI with laser photocoagulation for the treatment of macular edema secondary to BRVO.
Methods:
VIBRANT was a multicenter, double-masked, active-controlled, randomized, phase 3 trial. Treatment-naïve patients with unilateral macular edema secondary to BRVO were included in the study if they were diagnosed within 12 months and had a BCVA between 73 and 24 letters (20/40 to 20/320 Snellen equivalent). In VIBRANT, patients received either IAI 2 mg every 4 weeks (n = 91) or laser (n = 92) from baseline to week 20. The primary efficacy endpoint was the proportion of patients who gained ≥15 letters in best-corrected visual acuity (BCVA) from baseline to week 24. The secondary efficacy endpoints included the mean change from baseline in BCVA and central retinal thickness (CRT) at week 24.
Results:
The proportion of patients who gained ≥15 letters from baseline to week 24 was 53% in the IAI group compared with 27% in the laser group (P < .001). The mean improvement in BCVA from baseline to week 24 was 17.0 letters in the IAI group and 6.9 letters in the laser group (P < .0001). The mean reduction in CRT from baseline to week 24 was 280.5 μm in the IAI group and 128.8 μm in the laser group (P < .0001). The most common ocular adverse events in IAI patients were conjunctival hemorrhage (19.8%) and eye pain (4.4%). Over the 24 weeks of the study, traumatic cataract in an IAI patient was the only ocular serious adverse event (SAE) that occurred. The incidence of non-ocular SAEs was 8.8% in the IAI group and 9.8% in the laser group. One death due to pneumonia and one Anti-Platelet Trialists' Collaboration-defined event of non-fatal stroke occurred during the 24 weeks of the study, both in patients in the laser group. There were no cases of intraocular inflammation or endophthalmitis.
Conclusions:
Monthly injections of intravitreal aflibercept were well tolerated and significantly improved visual acuity at week 24 in patients with macular edema secondary to BRVO.
Keywords: 688 retina •
749 vascular occlusion/vascular occlusive disease