Intravitreal aflibercept for macular oedema due to branch retinal vein occlusion

Abstract

AbstractPurpose To evaluate the efficacy and safety of intravitreal aflibercept (IVT‐AFL) injection compared with macular grid laser photocoagulation for the treatment of macular oedema secondary to Branch Retinal Vein Occlusion (BRVO).Methods VIBRANT was a double‐masked, Phase 3 trial with a duration of 52 weeks in which patients with macular oedema secondary to BRVO were randomised 1:1 to receive IVT‐AFL 2 mg every 4 weeks or grid laser from baseline to Week 20. The primary efficacy endpoint was the proportion of eyes that gained ≥15 letters in best‐corrected visual acuity (BCVA) from baseline at Week 24.Results The proportion of eyes that gained ≥15 letters from baseline to Week 24 was 52.7% and 26.7% (P<0.001) in the IVT‐AFL and laser groups, respectively. The mean improvement in BCVA from baseline to Week 24 was 17.0 and 6.9 letters (P<0.0001), respectively. The most common ocular adverse events (AEs) in the IVT‐AFL and laser group were subconjunctival haemorrhage (19.8%) and eye pain (5.4%), respectively. There were no cases of intraocular inflammation in either treatment group. One death due to pneumonia and one Anti‐Platelet Trialists' Collaboration (APTC)‐defined event of nonfatal stroke occurred during the first 24 weeks of study, both in the laser group. Week 52 data will be presented.Conclusion In this study, monthly IVT‐AFL provided statistically significant and clinically meaningful visual benefits which were superior to macular grid laser photocoagulation in eyes with macular oedema due to BRVO over 24 weeks. Compared to IVT‐AFL’s known profile no new safety signals were observed. Commercial interest