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Patients treated with aflibercept intravitreal injections for macular edema associated with branch retinal vein occlusion had a significantly greater decrease in central retinal thickness and significantly greater improvement in vision compared with laser at the end of the 52-week VIBRANT trial.
Take-Home Message: Patients treated with aflibercept intravitreal injections for macular edema associated with branch retinal vein occlusion had a significantly greater decrease in central retinal thickness and significantly greater improvement in vision compared with laser at the end of the 52-week VIBRANT trial.
By Lynda Charters; Reviewed by Robert E. Leonard II, MD
Edmond, OK-Grid laser photocoagulation has been the “go-to” treatment for branch retinal vein occlusion (BRVO).
However, results from the VIBRANT trial of an anti-vascular endothelial growth factor (VEGF) agent, aflibercept (Eylea, Regeneron), indicate that might no longer be the case, according to Robert E. Leonard II, MD.
Patients treated with aflibercept had a significantly greater decrease in central retinal thickness and greater improvement in vision compared with conventional laser treatment, said Dr. Leonard, clinical professor of ophthalmology, Dean McGee Eye Institute/University of Oklahoma Health Sciences Center, Edmond, OK.
The 52-week, randomized, multicenter, double-masked trial was designed to investigate the safety and efficacy of aflibercept intravitreal injections on macular edema associated with BRVO. The 183 enrolled patients were randomly assigned to either 2 mg of aflibercept monthly or laser photocoagulation to treat macular edema in the center of the fovea to week 24 of the study.
After that time point, patients who had been randomly assigned to aflibercept then received the same dose of the drug every 8 weeks until the 52-week time point. Patients randomly assigned to laser could be treated with aflibercept rescue therapy after week 24, and those randomly assigned to the drug could undergo rescue laser therapy.
Both groups generally were well matched regarding the baseline demographics, Dr. Leonard noted.
The primary study endpoint was determination of the percentage of patients with improved best-corrected visual acuity (BCVA) by 15 or more letters on the Early Treatment Diabetic Retinopathy Study vision chart at week 24 compared with baseline.
Secondary endpoints were the mean changes in the BCVA and the central retinal thickness compared with baseline, he explained.
No patients had undergone previous treatment for BRVO and the macular hemorrhage must have cleared sufficiently to allow laser treatment.
Aflibercept is clearly more effective for managing macular edema associated with BRVO compared with laser, Dr. Leonard noted. Though more than 80% of patients randomly assigned to laser required rescue therapy with aflibercept, the percentage in the aflibercept arm that underwent rescue laser therapy was about 10%, he said.
Regarding efficacy, a significantly greater number of patients-i.e., almost double-in the aflibercept group gained 15 or more letters of visual acuity compared with the laser group.
“The data represent the pure treatment effect of the two study arms with no rescue therapy and clearly demonstrated the superiority of the aflibercept injections over laser photocoagulation,” Dr. Leonard said.
When investigators compared the visual acuity gains at week 24 with those at week 52, the differences remained significant between the two study arms. The laser group had a significant increase in the number of patients who gained three lines of vision, which represented the effect of rescue therapy. The aflibercept group continued to achieve additional gains in vision compared with week 24 with every 8-week dosing.
At 24 weeks, the aflibercept group gained a mean of about 17 letters compared with about seven letters in the laser group, a difference that reached significance. At week 52, the gains in vision were maintained in the aflibercept group, and the laser group showed gains in vision that were attributable to aflibercept rescue treatment, Dr. Leonard noted.
Reductions in the central retinal thickness also were significantly greater in the aflibercept compared with the laser group at week 24. After that time point, the laser group had a significant decrease in the central retinal thickness resulting from aflibercept rescue treatment.
The incidence rates of adverse events were similar in both treatment arms, with conjunctival hemorrhage, ocular pain, and irritation observed in both groups; inflammation developed only in association with laser treatment. Pneumonia and anemia developed in both groups. Cataract developed in one eye in the aflibercept group.
There were no cases of endophthalmitis in the study, Dr. Leonard said.
Anti-Platelet Trialists’ Collaboration-defined thromboembolic events did not develop in the aflibercept group, but a patient treated with laser and aflibercept rescue therapy had a nonfatal myocardial infarction during the 24-52 week segment of the study.
“Intravitreal aflibercept injection was superior to laser treatment through weea 52 of the VIBRANT trial for both visual acuity and anatomic outcomes,” Dr. Leonard said. “The every-8-week-treatment regimen maintained visual gains seen through week 52 of the study after six monthly injections. The laser control group gained an additional line of vision by week 52 after aflibercept rescue treatment was initiated.”
The intravitreal aflibercept injections were generally well tolerated by patients. The most common adverse events were typical of those associated with intravitreal injections, he added.
Robert E. Leonard II, MD
This article was adapted from Dr. Leonard’s presentation during Retina Subspecialty Day at the 2014 meeting of the American Academy Ophthalmology. Dr. Leonard did not indicate any proprietary interest in the subject matter.