Results from the Diabetic Retinopathy Clinical Research Retina Network’s Protocol V study have shown that treatment-naïve patients with good visual acuity but who have center-

involved diabetic macular edema can undergo observation and maintain good vision at a rate comparable to patients treated with intravitreal injections or laser photocoagulation, according to results presented at the annual meeting of the Association for Research in Vision and Ophthalmology.1 

Specifically, the study reported no significant difference in VA loss at two years regardless of whether the patient was treated with intravitreal drugs (16 percent), laser photocoagulation (17 percent) or left to observation (19 percent).

While the percentage of eyes with VA >20/20 was “significantly greater with aflibercept (Eylea, Regeneron Pharmaceuticals) than observation but not laser photocoagulation (one of five secondary visual acuity outcomes at two years and the only significant difference),” the range was such (about 2 letters) that its clinical significance is questionable, the DRCR.net authors wrote in the article simultaneously posted online by the Journal of the American Medical Association.

Protocol V involved patients with center-involved DME and VA >20/25. Second author Adam R. Glassman, MS, noted at ARVO that “it is a pretty common scenario” to have “a very small percentage” of patients with center-involved DME and good vision (20/25 or 20/32 or better) lose 1 line of vision or more at one year. 

In Protocol V, 702 randomized participants completed two-year follow-up. For eyes with VA that decreased from baseline, aflibercept was initiated in 25 and 34 percent of the laser photocoagulation and observation groups, respectively. At two years, the percentage of eyes with a <5-letter visual acuity decrease was 16 percent, 17 percent and 19 percent in the aflibercept, laser photocoagulation and observation groups, respectively.

The study found no statistically significant differences among groups when looking at >10 letter loss at two years, lead author Carl W. Baker, MD, said. There were no statistical differences in the percentage of eyes that gained vision, either, but “these eyes had good vision, so there was not a lot of room to gain,” Dr. Baker said.

“In Protocol V, the VA of 20/20 or better at two years was 77 percent in the aflibercept group, 71 percent in the laser group and 66 percent in the observation group,” he said.

Mr. Glassman noted the strategies for retreatment or treatment were quite different among the arms. “The aflibercept participants came back every four weeks through the first 24 weeks,” he said. “After 24 weeks, their visit schedule could extend from anywhere from eight to 16 weeks, depending on their treatment and their clinical course.”

The laser and observation participants were seen somewhat less frequently, at least initially. “They had visits at eight weeks and then again at 16 weeks, and we didn’t see them after that for another 16 weeks and another 16 weeks thereafter,” he said. If optical coherence tomography indicated worsening of center-involved DME, then patients returned earlier for additional visits. 

Baseline VA was similar across the arms, with some patients having 20/16 or better, Dr. Baker said. The mean number of visits was “around 18 in the groups that were treated initially with aflibercept,” Dr. Baker said. “In the laser and observation groups, the mean number was more like 13.” He attributed most of that difference to the more frequent visits by the aflibercept group, at least in the first six months.

REFERENCE

1. Baker CW, Glassman AR, Beaulieu WT, et al, for the DRCR Retina Network. Effect of initial management with aflibercept vs laser photocoagulation vs observation on vision loss among patients with diabetic macular edema involving the center of the macula and good visual acuity: A randomized clinical trial. JAMA. 2019 Apr 29. [Epub ahead of print]

IN BRIEF

The Food and Drug Administration gave final approval to an expanded indication for aflibercept (Eylea, Regeneron Pharmaceuticals): To treat all stages of diabetic retinopathy, with dosing as frequent as every four weeks after the first 20 weeks of treatment.

The FDA has accepted the biological license application for Novartis’ highly anticipated brolucizumab, a small-molecule anti-VEGF agent for treatment of neovascular age-related macular degeneration. If approved, Novartis anticipates launching brolucizumab by the end of the year.


The FDA has lifted a clinical hold on Adverum Biotechnologies’ gene therapy candidate ADVM-022 treatment for nAMD. The action allows dose escalation in the second cohort of the OPTIC Phase I trial at a dose three times higher than that in the first cohort. Dosing of the second cohort is expected to begin in June. 

ASRS Scientific Meeting packs more into fewer days, leaders say 

The 37th annual scientific meeting of the American Society of Retina Specialists, July 26 to 30 in Chicago, will be a day shorter than previous meetings, but program chair Carl C. Awh, MD, says that won’t detract from the program. 

“The heart of our meeting will continue to provide peer-reviewed research presented by ASRS members, but presentations will be shortened to allow more time for discussion,” Dr. Awh tells Retina Specialist

This year’s program includes the addition of expert “Take-Home Panels” to cover daily practice issues outside the scope of the peer-reviewed presentations. Another new offering Dr. Awh notes: “For the first time, ASRS will present a ‘Live Surgery Symposium,’ beaming world-renowned surgeons working in three different countries directly into the lecture hall.”

The final session on July 30 is titled “The Last Word,” which Dr. Awh describes as “a special panel discussion in which select presenters, nominated during the meeting by the audience and judges, will be given additional time to discuss the most controversial, fascinating and important topics of the meeting.”

ASRS President John S. Pollack, MD, says the meeting will offer attendees several options for exchanging ideas. “There will be numerous opportunities for meaningful discussions with audience participation throughout the meeting, with highlights being the medical and surgical case conferences, the live surgery program and, during the scientific session, Q&A periods,” he says.

Social events will include the Welcome Reception on the evening of July 26 and the Black Tie Gala at the Field Museum of Natural History on July 28. The Hyatt Regency in Chicago is the headquarters hotel for ASRS.

On the day before ASRS starts, the Ophthalmology Innovation Summit—a conference that attracts drug and technology companies with innovations in all stages of development—will host [email protected] at the Ritz-Carlton Chicago. The program includes showcases by public and private retina companies, along with panels on gene therapy, drug delivery and artificial intelligence. RS