Aflibercept Superior to Photocoagulation for Macular Edema?
Aflibercept Superior to Photocoagulation for Macular Edema?
Campochiaro PA, Clark WL, Boyer DS, et al
Ophthalmology. 2015;122:538-544
The VIBRANT study was a 24-week, double-masked, active-controlled, randomized, phase 3 trial comparing intravitreal aflibercept injection to macular grid laser photocoagulation for the treatment of macular edema after branch retinal vein occlusion (BRVO).
Patients received either 2 mg aflibercept every 4 weeks or macular grid laser performed at baseline and repeated between weeks 12 through 20 as indicated by predefined rescue criteria. After study completion, each group was eligible to receive the other treatment.
Ninety-one patients were included in the aflibercept group, and 92 patients were in the laser group.
The primary outcome, a gain of 15 or more ETDRS letters, was achieved by 53% of eyes in the aflibercept group and 27% in the laser group (P = .0003). Compared with the laser group, those receiving aflibercept had significantly better outcomes for mean time to first sustained gain in vision, proportion of eyes achieving different levels of visual gain and loss, mean change in best-corrected visual acuity from baseline, and change in central retinal thickness. No significant change was seen in National Eye Institute 25-item Visual Function Questionnaire total scores.
At least one ocular adverse event was experienced by 37% of patients in the aflibercept group and 27% in the laser group. The most common adverse event in the aflibercept group was subconjunctival hemorrhage (20%); in the laser group it was eye pain (5%). Three eyes, all in the laser group, developed neovascularization. One eye in the aflibercept group developed a traumatic cataract from the intravitreal injection.
This study was well-designed to examine the difference between macular laser given at baseline and intravitreal aflibercept injection. Although the BRAVO study had already shown the benefit of ranibizumab over macular laser for macular edema due to branch vein occlusion, this was the first study to examine anti-vascular endothelial growth factor injections vs macular laser given at baseline, instead of the 3-month waiting period put forth by the Branch Vein Occlusion Study Group. Given that ranibizumab was approved by the US Food and Drug Administration for BRVO in 2010, prior to the start of enrollment of patients in VIBRANT in 2012, it may have made for a more valuable control group and could have been used as rescue treatment.
Abstract
Intravitreal Aflibercept for Macular Edema Following Branch Retinal Vein Occlusion: The 24-Week Results of the VIBRANT Study
Campochiaro PA, Clark WL, Boyer DS, et al
Ophthalmology. 2015;122:538-544
Study Summary
The VIBRANT study was a 24-week, double-masked, active-controlled, randomized, phase 3 trial comparing intravitreal aflibercept injection to macular grid laser photocoagulation for the treatment of macular edema after branch retinal vein occlusion (BRVO).
Patients received either 2 mg aflibercept every 4 weeks or macular grid laser performed at baseline and repeated between weeks 12 through 20 as indicated by predefined rescue criteria. After study completion, each group was eligible to receive the other treatment.
Ninety-one patients were included in the aflibercept group, and 92 patients were in the laser group.
The primary outcome, a gain of 15 or more ETDRS letters, was achieved by 53% of eyes in the aflibercept group and 27% in the laser group (P = .0003). Compared with the laser group, those receiving aflibercept had significantly better outcomes for mean time to first sustained gain in vision, proportion of eyes achieving different levels of visual gain and loss, mean change in best-corrected visual acuity from baseline, and change in central retinal thickness. No significant change was seen in National Eye Institute 25-item Visual Function Questionnaire total scores.
At least one ocular adverse event was experienced by 37% of patients in the aflibercept group and 27% in the laser group. The most common adverse event in the aflibercept group was subconjunctival hemorrhage (20%); in the laser group it was eye pain (5%). Three eyes, all in the laser group, developed neovascularization. One eye in the aflibercept group developed a traumatic cataract from the intravitreal injection.
Viewpoint
This study was well-designed to examine the difference between macular laser given at baseline and intravitreal aflibercept injection. Although the BRAVO study had already shown the benefit of ranibizumab over macular laser for macular edema due to branch vein occlusion, this was the first study to examine anti-vascular endothelial growth factor injections vs macular laser given at baseline, instead of the 3-month waiting period put forth by the Branch Vein Occlusion Study Group. Given that ranibizumab was approved by the US Food and Drug Administration for BRVO in 2010, prior to the start of enrollment of patients in VIBRANT in 2012, it may have made for a more valuable control group and could have been used as rescue treatment.
Abstract
