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Monthly injections yielded superior vision increases, marked retinal thickness decreases
Monthly intravitreal injections of aflibercept achieved superior gains in visual acuity and significant decreases in macular edema in patients with branch retinal vein occlusion after 24 weeks.
By Lynda Charters; Reviewed by W. Lloyd Clark, MD
Columbia, SC-Monthly intravitreal injections of aflibercept (Eylea, Regeneron Pharmaceuticals) achieved superior gains in visual acuity and significant decreases in macular edema in patients with branch retinal vein occlusion (BRVO). The drug was also well tolerated.
Primary results of the VIBRANT Study-a phase III, multicenter, double-masked clinical trial of aflibercept for BRVO-were highlighted by W. Lloyd Clark, MD. The study included 183 patients who were randomly assigned to monthly aflibercept (n = 91) or laser at baseline (n = 92).
The primary endpoint was the percentage of patients who gained 3 lines (15 letters or more) of visual acuity.
Secondary endpoints were the mean changes in best-corrected visual acuity (BCVA) and central retinal thickness (CRT) measured on optical coherence tomography (OCT) images and the mean change in the National Eye Institute Visual Function Questionnaire-25 (VFQ-25) total score-all of which were assessed at week 24 of the study.
Patients continued in the study until week 52. However, the trial is ongoing, according to Dr. Clark, assistant clinical professor of ophthalmology, University of South Carolina School of Medicine, Columbia, SC, and in private practice, West Columbia, SC.
All patients were treatment-naïve and had center-involved macular edema and visual acuity levels between 20/40 and 20/320. The treatment groups were well balanced at the start of the study.
More than 90% of patients completed the week 24 evaluation.
The mean number of injections in the aflibercept group was 5.7 of a possible 6 injections. In the laser group, all patients were treated with laser at baseline and could receive additional laser at month 3 if needed. Most patients received the maximal laser treatment.
At week 24, 53% of eyes in the aflibercept group gained 15 or more letters of vision compared with 27% of eyes in the laser group (p < 0.001), Dr. Clark noted. Eyes treated with aflibercept gained 17 letters of BCVA at week 24 compared with 6.9 letters in the laser group (p < 0.0001). There was a “rapid and persistent” decrease (–280.5 µm) in the CRT seen on OCT images, while the decrease in the laser group was more moderate (–128.8 µm) (p < 0.0001), he said.
Both treatment groups also had an improvement in the quality of life measured on the VFQ-25.
The mean total score in the aflibercept group was 7.7 and that in the laser group 6.3-a difference that did not reach significance.
The implications of the quality-of-life results are unclear, because 98% of patients had a better eye upon study enrollment, according to Dr. Clark.
The aflibercept group had more ocular adverse events compared with the laser group, which were associated with the injection process. Conjunctival hemorrhages were by far the most common adverse event followed by ocular pain, foreign-body sensation, and tearing. Retinal neovascularization developed in 3 eyes in the laser group.
Development of a traumatic cataract in one patient was the only serious adverse event in the aflibercept group.
One death and one nonfatal stroke occurred in the laser group.
Systemic adverse events also occurred, but there was no difference between the two groups. No safety signals emerged between the treatment groups, he added.
“Monthly intravitreal aflibercept injections resulted in superior gains in visual acuity and significant reductions in macular edema compared with laser treatment,” he said.
W. Lloyd Clark, MD
Dr. Clark is a consultant to Regeneron Pharmaceuticals and has received research funding from the company.
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