DRCR.net Protocol S: Lucentis noninferior to panretinal photocoagulation for visual acuity
LAS VEGAS — Ranibizumab is noninferior to panretinal photocoagulation with regard to visual acuity outcomes at 2 years in patients with proliferative diabetic retinopathy, according to a study presented here.
“Lucentis (ranibizumab, Genentech) should be considered a viable treatment option for people with proliferative diabetic retinopathy, especially for individuals needing anti-VEGF for diabetic macular edema,” Jeffrey G. Gross, MD, said at the American Academy of Ophthalmology annual meeting.
Gross, protocol chair, delivered a report on 2-year outcomes of patients with proliferative diabetic retinopathy studied in the DRCR.net Protocol S.
The randomized multicenter clinical trial, published online in JAMA, evaluated noninferiority of ranibizumab vs. panretinal photocoagulation (PRP) with the primary endpoint of mean change in visual acuity letter score from baseline to 2 years. Across 55 U.S. clinical sites, 203 eyes were randomly assigned to receive PRP treatment, completed in 1 to 3 visits, and 191 eyes received 0.5 mg intravitreous ranibizumab at baseline and as frequently as every 4 weeks based on a structured re-treatment protocol, according to the study.
At 2 years, visual acuity improved by 2.8 letters from baseline in the ranibizumab group compared with an improvement of 0.2 letters from baseline in the PRP group, with a mean difference of 2.2 letters between treatment groups (P < .001).
The mean treatment group difference in visual acuity area under the curve over 2 years was 4.2 letters, although the clinical importance of this difference is unknown, the study said.
There was more peripheral visual field loss, with 213 dB in the ranibizumab group vs. 531 dB in the PRP group, and there were more vitrectomies performed in the PRP group, with 15% of eyes requiring vitrectomy compared with 4% of eyes in the ranibizumab group, according to the presentation.
When diabetic macular edema was present, ranibizumab was more effective than PRP in preserving central and peripheral visual function, “but cost, follow-up compliance, and patient preference need to be considered,” Gross said.
There were no substantial safety concerns for at least 2 years.
“Longer follow-ups should determine whether these effects are sustained enough throughout 5 years,” Gross concluded. — by Kristie L. Kahl
Gross JG. DRCR.net Prompt PRP vs ranibizumab+deferred PRP for PDR study (Protocol S). Presented at: American Academy of Ophthalmology. Nov. 13, 2015; Las Vegas.
Writing Committee for the Diabetic Retinopathy Clinical Research Network. JAMA 2015;doi:10.1001/jama.2015.15217.
Disclosure: Gross reports he is a speaker for Acucela and Jaeb Center for Health Research.