Nancy A. Melville

May 08, 2014

ORLANDO, Florida — Macular edema secondary to branch retinal vein occlusion is treated more effectively with monthly intravitrial injections of the vascular endothelial growth-factor (VEGF) inhibitor aflibercept than with laser therapy, a new phase 3 study shows.

"These findings demonstrate that treatment with anti-VEGF therapy alone may give excellent visual results without laser," said lead investigator David Boyer, MD, a clinical professor of ophthalmology at the University of Southern California and founder of the Retina-Vitreous Associates Medical Group in Los Angeles.

He presented results from the randomized, double-masked, multicenter VIBRANT study here at the Association for Research in Vision and Ophthalmology 2014 Annual Meeting,

The study involved 183 treatment-naïve patients with unilateral macular edema secondary to branch retinal vein occlusion. All patients were diagnosed in the previous 12 months and had best corrected visual acuity (BCVA) between 73 and 24 letters.

The patients were randomized to intravitrial aflibercept injections 2 mg every 4 weeks for 20 weeks (n = 91) or to laser photocoagulation (n = 92).

Table. Change From Baseline at 24-Week Follow-Up

Outcome Aflibercept Group Laser Group P Value
Gain of at least 15 letters in BCVA (%) 53 27 <.001
Mean improvement in BCVA (letters) 17.0 6.9 < .0001
Mean change in central retinal thickness (μm) 280.5 128.8 <.0001

 

In the aflibercept group, 19.8% of patients experienced conjunctival hemorrhage, which is believed to be related more to the injection itself than to the medication, and 4.4% experienced eye pain. The only serious adverse event in the aflibercept group was 1 case of traumatic cataract.

Rates of nonocular serious adverse events were similar in the aflibercept and laser groups (8.8% vs 9.8%). There were no cases of intraocular inflammation or endophthalmitis in either of the groups.

In the laser group, 1 patient died from pneumonia and another experienced a nonfatal stroke.

"The old paradigm we had for 15 years was that laser alone was the best treatment, but the paradigm does shift. We now have a treatment with better results," said Dr. Boyer.

"This is the first head-to-head comparison of an anti-VEGF agent with laser for macro edema, and it really showed a significant difference between the 2 groups," said Rishi Singh, MD, an ophthalmologist from the Cole Eye Institute, which is part of the Cleveland Clinic Foundation.

"Previous studies looked at anti-VEGF with laser delayed for up to 90 days following initiation of the study, but this is the first to compare them head to head," he told Medscape Medical News.

Dr. Singh pointed out that in some cases, a combination therapy might be an effective approach. "The laser arm in the study did improve vision — patients didn't have deterioration — but they just didn't improve as much as the anti-VEGF arm. If we can increase the durability by applying laser, that could be beneficial to patients," he explained.

The VIBRANT trial will be closely watched as the study moves forward, added Paul Mitchell, MD, PhD, professor of ophthalmology at the University of Sydney and director of the Centre for Vision Research at the Westmead Millennium Institute in Australia.

"This trial shows a major benefit on vision and macular edema with monthly aflibercept intravitreal therapy over the previous standard of care for branch retinal vein occlusion — grid laser treatment," he told Medscape Medical News.

It will be interesting to see if the benefit extends out to 1 year and 2 years, and whether 6 initial injections are needed for all patients "or whether an 'as needed' or 'inject and extend' approach will lead to a lower injection need," Dr. Mitchell said.

The study received support from Regeneron. Dr. Boyer reports financial relationships with Allegro, Allergan, Bausch & Lomb, Bayer, Genentech, and Thrombogenics. Dr. Singh reports financial relationships with Alcon, Thrombogenics, Regeneron, and Genentech. Dr. Mitchell reports financial relationships with Novartis, Bayer, Abbott, and Allergan.

Association for Research in Vision and Ophthalmology (ARVO) 2014 Annual Meeting: Abstract 604. Presented May 4, 2014.

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