Primary outcome data from a phase III clinical trial evaluating aflibercept (Eylea, Regeneron) for macular edema (ME) due to branch retinal vein occlusion (BRVO) show that intravitreal treatment with the anti-VEGF agent was well tolerated and associated with significantly better improvements in visual acuity and central retinal thickness (CRT) than laser photocoagulation.
West Columbia, SC-Primary outcome data from a phase III clinical trial evaluating aflibercept (Eylea, Regeneron) for macular edema (ME) due to branch retinal vein occlusion (BRVO) show that intravitreal treatment with the anti-VEGF agent was well tolerated and associated with significantly better improvements in visual acuity and central retinal thickness (CRT) than laser photocoagulation.
W. Lloyd Clark, MD- a retinal specialist in private practice, Palmetto Retina Center, West Columbia, SC-reported the data from the 24-week visit in the ongoing VIBRANT study.
The double-masked trial randomly assigned 183 patients 1:1 to monthly injections of aflibercept 2 mg or laser. Eligible patients had center-involved ME diagnosed within 12 months of screening, best-corrected visual acuity between 20/40 and 20/320, sufficient clearing of intraretinal hemorrhage to allow for baseline laser treatment, and were treatment naïve.
The two treatment groups were well balanced in their demographic and baseline disease characteristics, and more than 90% of patients in both treatment arms completed the primary outcome visit at week 24. Patients in the laser group could be re-treated at week 12 if they met protocol-specified re-treatment criteria, and most received a second treatment. Patients in the aflibercept group received a mean of 5.7 injections.
The primary efficacy endpoint of ≥15 letters improvement from baseline BCVA was met by 53% of aflibercept eyes and 27% of laser-treated eyes. Secondary efficacy data analyzing mean change from baseline visual acuity and mean decrease in central retinal thickness also showed superior results for aflibercept versus laser.
Quality of life was assessed using the NEI VFQ-25 questionnaire.
Both groups demonstrated improved scores from baseline at week 24 with no significant difference between groups.
The safety review showed ocular adverse events in the study eye were more common in the aflibercept-treated eyes compared with the laser group-38% versus 27%-but there was no difference between groups in systemic adverse events, and serious adverse events were well-balanced between groups. Three eyes in the laser group demonstrated retinal neovascularization during the 24 weeks of follow-up. The only serious ocular adverse event among aflibercept-treated eyes was a case of traumatic cataract.
“The most common ocular adverse events in aflibercept-treated eyes were those associated with intravitreal injection procedures,” Dr. Clark said. “There was one death and one non-fatal stroke during the first 24 weeks of the study, and both of those events were in the laser group. There were no deaths or cardiovascular events in aflibercept-treated patients.”
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