Speaker delivers DRCR.net update at Angiogenesis meeting

MIAMI — Harry W. Flynn Jr., MD, discussed the newly published and continuing trials of the Diabetic Retinopathy Clinical Research Network at Angiogenesis, Exudation, and Degeneration 2016.

Protocol S, which was recently published, showed that intravitreal Lucentis (ranibizumab, Genentech) was not inferior to panretinal photocoagulation for diabetic macular edema and resulted in better visual acuity over 2 years. The ranibizumab group had a higher chance of a 10-letter score improvement or better, while the PRP group had a higher chance of visual acuity worsening by 10 letters or more, as well as a higher chance for pars plana vitrectomy and vitreous hemorrhage.

Protocol T, published in October 2015, compared the safety and efficacy of intravitreal Eylea (aflibercept, Regeneron), Avastin (bevacizumab, Genentech) and ranibizumab to treat central-involved DME in eyes with visual acuity of 20/32 to 20/320. All three anti-VEGF agents were effective, and there was little difference in visual acuity at 1 year, Flynn said.

At worse levels of initial visual acuity, aflibercept may be more effective in improving visual acuity, while post hoc findings determined that eyes with better initial visual acuity and thicker central corneal thickness have worse visual acuity outcomes with bevacizumab treatment.

The 2-year outcomes will be announced in March, Flynn said.

“Clearly anti-VEGF therapy is effective with all three agents. Now we just need the 2-year data to really determine the long-term benefits,” he said.

Protocol V, a randomized multicenter clinical trial, is currently comparing treatment for DME in eyes with very good visual acuity using prompt ranibizumab, prompt laser and deferred ranibizumab, or observation with deferred ranibizumab. The primary outcome will be the proportion of eyes that have lost five or more letters of visual acuity at 2 years.

In 2010, Protocol D evaluated the factors associated with favorable outcomes after vitrectomy for DME. After 6 months, preoperative presence of vitreoretinal abnormalities was associated with greater reductions in retinal thickness, but not with improved visual acuity outcomes.

Therefore, Protocol I evaluated eyes with and without prior vitrectomy treated with ranibizumab for 6 months. Outcomes were equal among all groups, thus meaning that vitrectomy is not a disadvantage in treating DME, Flynn said.

A post hoc exploratory analysis, published in January, determined that 40.1% of the 117 eyes with persistent DME at the 24-week follow-up and continued anti-VEGF treatment still had DME at 3 years. Among the 40 eyes with chronic persistent DME through 3 years, 17 eyes gained 10 letters or more of visual acuity from baseline and five eyes lost 10 letters or more from baseline.

“Long-term improvement in visual acuity from baseline continued,” Flynn said. “Any substantial loss of visual acuity is likely uncommon through 3 years, even with chronic persistent DME.”

Lastly, Protocol M assessed the effect of personalized diabetes risk assessments during ophthalmic visits. The randomized trial determined that the addition of personalized education and risk assessment during office visits did not help glycemic control.

“These results suggest that optimizing glycemic control remains a substantive challenge for all of us in medicine,” Flynn said. – by Kristie L. Kahl

Disclosure: Flynn reports no relevant financial disclosures.