Randomized Trial of Monthly Versus As-Needed Intravitreal Ranibizumab for Radiation Retinopathy–Related Macular Edema: 1-Year Outcomes

To assess efficacy of intravitreal ranibizumab injections and targeted panretinal photocoagulation (TRP) for radiation retinopathy–related macular edema. Phase IIb, prospective, randomized clinical trial. Setting: Multicenter. Subjects: Forty eyes in 40 treatment-naïve patients with radiation-induced macular edema and a resulting decrease in visual acuity ranging between 20/25 and 20/400 (Snellen equivalent). Intervention: Patients either received intravitreal 0.5 mg ranibizumab monthly, monthly ranibizumab with TRP, or 3 monthly ranibizumab (loading doses) followed by as-needed (PRN) injections and TRP. After week 52, all subjects entered a treat-and-extend protocol for ranibizumab. MainOutcomeMeasures: Mean Early Treatment Diabetic Maculopathy Study (ETDRS) BCVA change from baseline. Mean patient age was 57 years (range, 22-80 years), ETDRS BCVA was 56.7 letters (20/74 Snellen equivalent), and central macular thickness (CMT) was 423 μm (range, 183-826 μm). Thirty-seven patients completed the month 12 visit (92.5%), at which time the change in mean BCVA was +4.0 letters, −1.9 letters, and +0.9 letters in the monthly, monthly plus laser, and PRN plus laser cohorts, respectively. There was a significant difference in mean BCVA at 1 year among all 3 cohorts (P < .001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group. A total of 82.5% of the patients retained visual acuity of 20/200 or better, and 20.0% improved 10 or more ETDRS letters. Ranibizumab may improve vision and anatomy in patients with radiation retinopathy–related macular edema and prevent vision loss through 48 weeks of therapy. Monthly injections were more effective than as-needed approach, and the addition of TRP yielded no therapeutic benefits. •Radiation retinopathy is a visually devastating complication of radiation therapy.•There is currently no US Food & Drug Administration–approved treatment for radiation retinopathy.•Monthly ranibizumab injections led to the biggest improvement in vision at 1 year.•Targeted panretinal photocoagulation had no additional therapeutic benefits.•All treatment arms led to significantly better vision than historical controls.