Amy C Schefler1, Dwain Fuller2, Rajiv Anand2, Timothy Fuller2, Chelsey Moore3, Jose Munoz3, Ryan S Kim4. 1. Retina Consultants of Houston, 6560 Fannin Street Ste 750, Houston, TX 77030; Blanton Eye Institute, Houston Methodist Hospital, Houston, 6560 Fannin Street Ste 450, Houston, TX 77030. Electronic address: acsmd@houstonretina.com. 2. Texas Retina Associates, 9600 N. Central Expressway, Suite 100, Dallas, TX 75231. 3. Retina Consultants of Houston, 6560 Fannin Street Ste 750, Houston, TX 77030. 4. Retina Consultants of Houston, 6560 Fannin Street Ste 750, Houston, TX 77030; McGovern Medical School, University of Texas Health Science Center, 6431 Fannin Street, Houston, TX 77030.
Abstract
PURPOSE: To assess efficacy of intravitreal ranibizumab injections and targeted pan-retinal photocoagulation (TRP) for radiation retinopathy-related macular edema. DESIGN: Phase IIb, prospective, randomized clinical trial. SETTING: multi-center PATIENTS: 40 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 0.5mg 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. MAIN OUTCOME MEASURES: Mean ETDRS BCVA change from baseline. RESULTS:Mean patient age was 57 years (range, 22-80), ETDRS BCVA was 56.7 letters (20/74 Snellen-equivalent), and central macular thickness (CMT) was 423 um (range, 183-826). 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 three cohorts (p<0.001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group. 82.5% of the patients retained visual acuity of 20/200 or better, and 20.0% improved 10 or more ETDRS letters. CONCLUSIONS: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.
RCT Entities:
PURPOSE: To assess efficacy of intravitreal ranibizumab injections and targeted pan-retinal photocoagulation (TRP) for radiation retinopathy-related macular edema. DESIGN: Phase IIb, prospective, randomized clinical trial. SETTING: multi-center PATIENTS: 40 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 0.5mg 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. MAIN OUTCOME MEASURES: Mean ETDRS BCVA change from baseline. RESULTS: Mean patient age was 57 years (range, 22-80), ETDRS BCVA was 56.7 letters (20/74 Snellen-equivalent), and central macular thickness (CMT) was 423 um (range, 183-826). 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 three cohorts (p<0.001), as well as between cohorts in pairwise comparisons, with the most significant gains in the monthly group. 82.5% of the patients retained visual acuity of 20/200 or better, and 20.0% improved 10 or more ETDRS letters. CONCLUSIONS: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.