Mei Hong Tan1, Ian L McAllister2, Mark E Gillies3, Nitin Verma4, Gayatri Banerjee5, Lynne A Smithies6, Wan-Ling Wong7, Tien Y Wong8. 1. Centre for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Australia; Department of Ophthalmology, Royal Perth Hospital, Perth, Australia. Electronic address: meihongtan@gmail.com. 2. Centre for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Australia; Department of Ophthalmology, Royal Perth Hospital, Perth, Australia. 3. Save Sight Institute, Sydney, Australia. 4. Hobarts Eye Surgeons, School of Medicine, University of Tasmania, Tasmania, Australia. 5. Central Sydney Eye Surgeons, Sydney, Australia. 6. Centre for Ophthalmology and Visual Science, Lions Eye Institute, The University of Western Australia, Perth, Australia. 7. Singapore Eye Research Institute, National University of Singapore, Singapore. 8. Singapore Eye Research Institute, National University of Singapore, Singapore; Centre for Eye Research Australia, Royal Victorian Eye and Ear Hospital, Melbourne, Australia.
Abstract
PURPOSE: To assess the efficacy of intravitreal 0.5 mg ranibizumab for the treatment of center-involving macular edema secondary to branch retinal vein occlusion (BRVO) over 1 year compared with standard-of-care grid laser. DESIGN: A prospective randomized controlled clinical trial. METHODS: A total of 36 patients with vision loss in 1 eye attributable to macular edema following BRVO were recruited from 5 institutions. Patients were randomized 1:1 to a treatment group that received 6 monthly injections of 0.5 mg ranibizumab and thereafter monthly as needed based on best-corrected visual acuity (BCVA) and central foveal thickness (CFT) assessments on optical coherence tomography scans, or a standard-of-care group that received monthly sham injections for the 1-year duration of the study. Grid laser was administered at 13 and 25 weeks in both groups if criteria for laser treatment were met. Main outcome measures included mean change in BCVA in Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores from baseline to month 12. Secondary outcomes included anatomic outcomes and the percentage of patients requiring grid laser in both groups. RESULTS:Mean BCVA change from baseline was significantly greater in the treatment compared with the standard-of-care group at 12 months (12.5 ETDRS letters vs -1.6 ETDRS letters, P = .032). The mean CFT was significantly reduced in the treatment compared with standard-of-care group (361.7 μm vs 175.6 μm, P = .025). At 13 and 25 weeks, more patients in the standard-of-care group (68.4%, 50.0%) received grid laser than in the treatment group (6.7%, 8.3%). No new ocular or systemic adverse events were observed. CONCLUSIONS: Compared with standard grid laser, intravitreal ranibizumab provided significant and sustained benefits in visual acuity gain and anatomic improvement in eyes with macular edema secondary to BRVO.
RCT Entities:
PURPOSE: To assess the efficacy of intravitreal 0.5 mg ranibizumab for the treatment of center-involving macular edema secondary to branch retinal vein occlusion (BRVO) over 1 year compared with standard-of-care grid laser. DESIGN: A prospective randomized controlled clinical trial. METHODS: A total of 36 patients with vision loss in 1 eye attributable to macular edema following BRVO were recruited from 5 institutions. Patients were randomized 1:1 to a treatment group that received 6 monthly injections of 0.5 mg ranibizumab and thereafter monthly as needed based on best-corrected visual acuity (BCVA) and central foveal thickness (CFT) assessments on optical coherence tomography scans, or a standard-of-care group that received monthly sham injections for the 1-year duration of the study. Grid laser was administered at 13 and 25 weeks in both groups if criteria for laser treatment were met. Main outcome measures included mean change in BCVA in Early Treatment Diabetic Retinopathy Study (ETDRS) letter scores from baseline to month 12. Secondary outcomes included anatomic outcomes and the percentage of patients requiring grid laser in both groups. RESULTS: Mean BCVA change from baseline was significantly greater in the treatment compared with the standard-of-care group at 12 months (12.5 ETDRS letters vs -1.6 ETDRS letters, P = .032). The mean CFT was significantly reduced in the treatment compared with standard-of-care group (361.7 μm vs 175.6 μm, P = .025). At 13 and 25 weeks, more patients in the standard-of-care group (68.4%, 50.0%) received grid laser than in the treatment group (6.7%, 8.3%). No new ocular or systemic adverse events were observed. CONCLUSIONS: Compared with standard grid laser, intravitreal ranibizumab provided significant and sustained benefits in visual acuity gain and anatomic improvement in eyes with macular edema secondary to BRVO.