Five-Year Outcomes of Randomized Trial Comparing Laser with Ranibizumab for PDR
JAMA Ophthalmology, October 2018
Gross et al. compared the efficacy and safety of intravitreous ranibizumab and panretinal photocoagulation (PRP) for proliferative diabetic retinopathy (PDR) through 5 years in a randomized clinical trial. They found that visual acuity (VA) was very good for most patients in both study arms, consistent with 2-year outcomes. Rates of vision-impairing diabetic macular edema (DME) were lower in the ranibizumab group.
This study included patients who had enrolled in the Diabetic Retinopathy Clinical Research Network (DRCR.net) Protocol S trial by December 2012. Eyes had been assigned randomly to receive intravitreous ranibizumab (n = 191) or PRP (n = 203). The fre-quency of ranibizumab treatment was based on a protocol-specified algorithm. The 5-year analysis began in January 2018. The main outcome was the mean change in VA; secondary outcomes included peripheral visual field loss, development of vision-impairing DME, and adverse events.
The 5-year visit was completed for 240 eyes (184 patients), 117 of which received ranibizumab. The mean number of treatments over 5 years was 19.2 in the ranibizumab group (with an average of 3 injections each year in years 2, 3, 4, and 5) and a mean of 5.4 treatments over 5 years in the PRP group. Mean changes in VA letter score were 3.1 and 3.0, respectively, for the ranibizumab and PRP groups. The mean change in cumulative visual field total point score was −330 dB for ranibizumab recipients and −527 dB for patients with PRP. Vision-impairing DME occurred in 27 and 53 eyes, respectively, for a cumulative probability of 22% in the ranibizumab group and 38% in the PRP group (hazard ratio = 0.4; 95% confidence interval [CI]: 0.3-0.7; p < 001).
Despite a mean VA of 20/25 in both groups at 5 years, vitreous hemorrhage occurred in 48% of eyes treated with ranibizumab and in 46% of eyes treated with PRP. Vitrectomy was performed in 11% and 19% of eyes, respectively. Both groups had low rates of iris neovascularization and neovascular glaucoma, although retinal detachment occurred in 6% of the ranibizumab group and 15% of the PRP group. Rates of systemic adverse events were comparable.
The authors note that these findings support either anti–vascular endothelial growth factor therapy or PRP as viable treatments for patients with PDR through at least 5 years and emphasize the importance of considering patient-specific factors when selecting a treatment, including the patient’s anticipated likelihood of compliance and overall health status as well as cost issues.
The original article can be found here.