Parallel trials show aflibercept superior to laser in DME treatment
HAMBURG — Results of two phase III multicentered trials, first disclosed here at the Euretina meeting, showed superior efficacy of aflibercept compared to conventional laser photocoagulation in the treatment of diabetic macular edema.
The two studies, VISTA-DME and VIVID-DME, involved 54 centers in the United States and 73 centers in Europe, Japan and Australia and included 865 patients.
“The aflibercept groups demonstrated significant and robust superiority of BCVA endpoints over laser photocoagulation at week 52 with a mean gain between 10 and 12 letters. Intravitreal injections were well tolerated with a safety profile similar to that observed in neovascular age-related macular degeneration and central retinal vein occlusion,” Ursula Schmidt-Erfurth, MD, said.
Patients were randomized between one control arm, which treated via conventional laser photocoagulation, and two active treatment arms involving a 2mg aflibercept (Eylea, Regeneron) dose either monthly or every two months. A loading dose of 5 monthly injections was administered in both aflibercept groups. Laser treatment could be repeated with 3-month intervals if clinically necessary.
The different time schedules resulted in similar efficacy. Mean BCVA improvement ranged between 10.5 and 12.5 letters.
“This is the best benefit you can achieve in this kind of disease,” Schimidt-Erfurth said. “The bimonthly regimen can potentially decrease the injection-related burden on patients, caregivers, physicians and overall healthcare system.”
No difference between the two treatment groups was found in serious systemic adverse events. Most side effects were the ones commonly known after intravitreal procedures. No case of endophthlamitis was found in spite of the immunological conditions of diabetic patients.
The trial is ongoing and is aimed at long-term evaluation over 3-4 years follow-up.
Disclosure: Schmidt-Erfurth has served as a consultant for Allergan, Alcon, Bayer HealthCare, Boehringer, Novartis and received travel support for presentation at scientific meetings.