- 作者：Mei Hong Tan ; Ian L. Mcallister ; Mark E. Gillies ; Nitin Verma ; Gayatri Banerjee ; Lynne A. Smithies ; Wan-Ling Wong ; Tien Y. Wong
- 刊名：American Journal of Ophthalmology
- 出版年：January, 2014
- 年：2014
- 卷：157
- 期：1
- 页码：237-247.e1
- 全文大小：1032 K
Purpose
To assess the efficacy of intravitreal 0.5聽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聽monthly injections of 0.5聽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聽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聽months (12.5 ETDRS letters vs -1.6 ETDRS letters, P聽= .032). The mean CFT was significantly reduced in the treatment compared with standard-of-care group (361.7聽渭m vs 175.6聽渭m, P聽= .025). At 13 and 25聽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.