DRCR.net study to compare treatment, observation in DME with good visual acuity

PHILADELPHIA — An upcoming phase 3 study will focus on when to treat or observe eyes with center-involved diabetic macular edema and good visual acuity, an expert told colleagues here.

“We don’t even know if anti-VEGF does give us better vision and how much better it is. Does it warrant that we should really consider this? Is it just a couple of letters better and it really makes no difference? How many injections do we really need to maintain these eyes at 20/20?” Neil M. Bressler, MD, said at Macula 2014.

The Diabetic Retinopathy Clinical Research Network (DRCR.net) is currently enrolling patients who will be randomized to undergo prompt focal/grid laser photocoagulation with deferred intravitreal Eylea (aflibercept, Regeneron), observation with deferred aflibercept or prompt aflibercept, Bressler said.

Previous studies by DRCR.net and others have shown that prompt Lucentis (ranibizumab, Genentech) improved vision better than prompt grid laser in eyes with visual acuity of 20/32 or worse, Bressler said.

“So, anti-VEGF therapies have not yet been evaluated in eyes that have center-involved edema that are 20/25 or better,” he said.

Patient enrollment should be completed within 1 year, Bressler said.

“Stay tuned. We’ll do what we think is best for now, and we’ll have additional data to add to our opinions a few years from now,” Bressler said.

Disclosure: Bressler has performed contracted research for Bayer and Novartis.

Reference

Treatment for CI-DME in eyes with very good VA study (Protocol V). ClinicalTrials.gov. clinicaltrials.gov/ct2/show/NCT01909791. Updated Nov. 20, 2013. Accessed Jan. 15, 2014.