—Intravitreal aflibercept (Eylea, Regeneron Pharmaceuticals) seems to have similar efficacy in patients with diabetic macular edema (DME) who had been treated previously with anti-vascular endothelial growth factor therapy (VEGF) as in those with DME who were anti-VEGF treatment naïve.
“The outcomes thus far from the VISTA-DME/VIVID-DME phase III trials indicate that the group treated with 2 mg of aflibercept every 8 weeks after 5 monthly doses had similar outcomes to the group treated with 2 mg of aflibercept every 4 weeks, regardless of prior anti-VEGF therapy,” said Charles C. Wykoff, MD, PhD.
The VISTA-DME/VIVID-DME study is a randomized, multicenter, double-masked trial that evaluated the efficacy of intravitreal injections of aflibercept in patients with clinically relevant DME that involved the central macula and best-corrected visual acuity (BCVA) of 20/40 to 20/320.
The VISTA segment of the study included 466 U.S. patients, whereas the VIVID segment included 406 patients from outside the United States.
Patients were randomly assigned either to focal macular laser photocoagulation or one of two doses of intravitreal aflibercept: 2 mg every 4 weeks or 2 mg every 8 weeks following 5 consecutive monthly doses, said Dr. Wykoff, who is in private practice, Houston.
The primary endpoint was the mean change in the BCVA at 52 weeks. Secondary endpoints included change in central retinal thickness and the Diabetic Retinopathy Severity Score at 52 and 100 weeks.
Prior anti-VEGF treatment could have included ranibizumab (Lucentis, Genentech), bevacizumab (Avastin, Genentech), and/or pegaptanib (Macugen, Pfizer/Eyetech Pharmaceuticals).
Visual acuity improvements
Analysis of the mean changes in BCVA through week 100 indicated that the two aflibercept arms resulted in similar improvements in visual acuity in patients who had been treated previously and in those who were anti-VEGF treatment naïve, with increases of about 11 to 13 Early Treatment Diabetic Retinopathy study (ETDRS) letters.
Concurrent with visual acuity improvmentsimprovements, patients treated with aflibercept experienced decreases in central retinal thicknesses that ranged from about 160 to 190 µm regardless of prior anti-VEGF treatment status.
At week 100, 35.8% of patients with DME who had received previous anti-VEGF therapy and then 2 mg of aflibercept every 4 weeks had a gain of 15 or more ETDRS letters, as did 29.4% of patients who received 2 mg of aflibercept every 8 weeks following 5 monthly doses, Dr. Wykoff said.
Those values were significantly better than patients treated with focal macular laser, with 7.9% achieving a gain of 15 or more letters. Comparable visual acuity improvements were achieved in anti-VEGF treatment-naïve patients, 40.2% and 36.1%, respectively, in contrast to 16.5% in the laser-treated group.
At week 100, among patients treated previously with anti-VEGF therapy, 15.9% of laser-treated patients, 37.3% of patients treated with 2 mg of aflibercept every 4 weeks, and 38.2% of those treated 2 mg of aflibercept every 8 weeks after 5 monthly doses had an improvement in the Diabetic Retinopathy Severity Score of two or more steps.
The respective percentages for treatment-naïve patients were 15.4%, 36.8%, and 36.1%, Dr. Wykoff noted.
No major differences were observed among the treatment arms regarding ocular adverse events, serious adverse events, systemic serious adverse events, and ocular inflammation.
Charles C. Wykoff, MD, PhD
E: [email protected]
This article was based on a presentation by Dr. Wykoff at the 2014 meeting of the American Society of Retina Specialists. Dr. Wykoff is a consultant and speaker for and receives research funding from Alcon Laboratories, Allergan, Genentech, and Regeneron.