Abstract
Purpose :
To evaluate the anatomic retinal changes in patients undergoing intravitreal ranibizumab with or without targeted panretinal photocoagulation for radiation retinopathy-related macular edema (RR-CME).
Methods :
This was a Phase II, prospective, multicenter, randomized trial. In the first year of the trial, patients with RR-CME were randomized 1:2:2 to monthly ranibizumab versus monthly ranibizumab with targeted PRP (TRP) versus PRN ranibizumab. In the second year of the trial, all patients were assigned to a treat-and-extend regimen following pre-specified SD-OCT re-injection criteria. This presentation will focus specifically on the anatomic outcomes in the first and second year of the trial.
Results :
At study entry, the mean central retinal thickness (CMT) was 385 μm. At one year, the mean change in CMT was -97 μm, -105 μm, and -87 μm in the monthly, monthly plus laser, and PRN cohorts, respectively. There was a statistically significant difference between mean CMT in the monthly cohort and the PRN cohort (p=0.002) at one year, as well as a statistically significant difference in the mean CMT between the monthly plus laser cohort and the PRN cohort (p=0.002). There was a statistically significant decrease in retinal hemorrhages, exudates, and ischemia in all three cohorts compared to baseline at one year (p<0.05). Two year results evaluating the effect of the treat-and-extend strategy on anatomic changes as measured by SD-OCT, fundus photography, fluorescein angiography, and OCT angiography will be available in early March 2019 and will be presented.
Conclusions :
Patients in all three cohorts in the RRR trial had a mean improvement in central macular thickness as measured by SD-OCT at one year. Two year results reflecting less frequent treatment, more reflective of real world care, will demonstrate the durability of the improvement observed in year one.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.