Visual Gains With Aflibercept Upheld at 52 Weeks in VIBRANT

Lara C. Pullen, PhD

December 08, 2014

CHICAGO — For patients with macular edema related to branch retinal vein occlusion, monthly intravitreal aflibercept (Eylea, Regeneron) injections can lead to visual gains at 24 weeks that are maintained at 52 weeks, report investigators from the multicenter phase 3 VIBRANT trial.

In aflibercept-treated patients, 57% had three or more lines of improvement at week 52, David Brown, MD, from Retina Consultants of Houston, said here at the American Academy of Ophthalmology 2014 Annual Meeting.

Retinal vein occlusion is the most common retinal vascular disorder after diabetic retinopathy, and branch occlusion is the most common form. The condition can be a significant cause of visual impairment.

The VIBRANT efficacy and safety trial was the first to compare vascular endothelial growth factor (VEGF) inhibitor therapy with laser therapy.

Study participants were treatment-naïve patients with unilateral macular edema secondary to branch retinal vein occlusion who were diagnosed in the previous 12 months. They had a best corrected visual acuity (BCVA) of 73 to 24 letters (Snellen equivalent of 20/40 to 20/320).

The primary efficacy end point was the proportion of eyes that gained at least 15 letters in BCVA by week 24.

 
Do new blood vessels grow? I think so.
 

Eyes with macular edema secondary to branch retinal vein occlusion were randomized to receive intravitreal aflibercept injections 2 mg every 4 weeks or grid laser therapy from baseline to week 20.

As previously reported by Medscape Medical News, at 24 weeks, significantly more patients in the aflibercept group than in the laser group had visual gains (53% vs 27%; P < .001).

When asked about the mechanism of action leading to the dramatic results, Dr. Brown said, "Do new blood vessels grow? I think so."

Beyond 24 Weeks

From week 24 on, eyes in the aflibercept group received 2 mg every 8 weeks. If patients required rescue, which approximately 10% did, they could be treated with laser therapy at week 36.

Patients in the laser group who required rescue could receive, any time it was deemed necessary, aflibercept 2 mg every 8 weeks after 3 initial monthly doses. Approximately 80% of the laser group went on to receive aflibercept rescue therapy.

The rescue therapy was beneficial if given before 24 weeks. "Six months looks to be too late to treat these patients," Dr. Brown explained.

The most common adverse event in eyes treated with aflibercept was conjunctival hemorrhage (19.8%). There were no reports of serious ocular adverse events.

The results suggest that the edema in retinal vein occlusion is mediated by VEGF, and that all such occlusions are ischemic.

The presentation was well received by the retina panel. Baruch Kuppermann, MD, from the University of California, Irvine, called the work excellent and pointed out that the study reveals that "there are other factors" behind macular edema.

Dr. Brown acknowledged that there are likely more factors than just VEGF. "When the retina is hungry and dying, it sends out a lot of cries for help," he explained.

This study was funded by Regeneron. Dr. Brown and Dr. Kuppermann are consultants for Regeneron and other pharmaceutical companies.

American Academy of Ophthalmology (AAO) 2014 Annual Meeting: Abstract PA091. Presented October 21, 2014.

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