Abstract
Purpose :
To evaluate the efficacy of intravitreal ranibizumab with or without targeted panretinal photocoagulation (TRP) for radiation retinopathy-related macular edema (RR-CME).
Methods :
This was a Phase II, prospective, multicenter, randomized trial. Patients with RR-CME who had a best corrected visual acuity (BCVA) of 20/25 to 20/400 at baseline were randomly assigned in 1:2:2 ratio for the first year to: monthly 0.5 mg intravitreal ranibizumab injections; monthly 0.5 mg ranibizumab plus TRP; loading dose of 0.5 mg ranibizumab and TRP, followed by PRN ranibizumab. In year 2, all cohorts were assigned to a standardized treat-and-extend regimen following pre-specified OCT reinjection criteria.
Results :
Forty subjects with a mean age of 57 at baseline (range, 22-80) were enrolled. Baseline mean BCVA was 56.9 letters (Snellen equivalent, 20/62.5), and mean CMT was 423 um (range, 183-826). Mean ETDRS letters changed from 56.9, 55.6 and 60.3 at baseline to 60.9, 56.1 and 58.7 at Week 48 for the monthly cohort, monthly/TRP cohort, and PRN cohort, respectively.
Conclusions :
BCVA of all patients improved at one year compared to historical controls with 87% of patients in all cohorts having 20/200 or better vision and 24% of patients gaining 10 or more letters at one year. The monthly ranibizumab cohort demonstrated a statistically significant BCVA gain at one year compared to the other two cohorts (p<0.0001 for both pairwise comparisons). Two year visual acuity results, available in March 2019, will be presented.
This abstract was presented at the 2019 ARVO Annual Meeting, held in Vancouver, Canada, April 28 - May 2, 2019.