研究目的
To identify baseline patient characteristics associated with early clinically significant visual acuity improvements within 3 months of treatment initiation in ranibizumab-treated patients with retinal vein occlusion.
研究成果
Better baseline BCVA, greater baseline total macular volume, and presence of subretinal fluid at baseline were associated with more rapid vision gains in ranibizumab-treated patients with RVO. These factors can help guide treatment expectations, but confirmation through prospective studies is needed.
研究不足
This was a post hoc analysis, not prespecified, and may not have been sufficiently powered for all baseline predictor endpoints. Baseline groups were not evenly distributed, and the findings may not be generalizable due to the specific study population and design.
1:Experimental Design and Method Selection:
Post hoc analysis of data from the SHORE study, which was a randomized, open-label, vision examiner–masked phase 4 study comparing monthly versus pro re nata dosing of ranibizumab in patients with branch and central retinal vein occlusion. The analysis used Kaplan-Meier method and log-rank test to evaluate time to visual outcomes.
2:Sample Selection and Data Sources:
Data from 202 patients enrolled in the SHORE study, who met eligibility criteria including macular edema involving the foveal center due to RVO diagnosed within 12 months prior to screening, and ETDRS Protocol BCVA of 20/40–20/
3:List of Experimental Equipment and Materials:
3 Ranibizumab 0.5 mg injections, spectral-domain optical coherence tomography for measuring macular volume and subretinal fluid.
4:5 mg injections, spectral-domain optical coherence tomography for measuring macular volume and subretinal fluid.
Experimental Procedures and Operational Workflow:
4. Experimental Procedures and Operational Workflow: Patients received 7 monthly ranibizumab injections at months 0–6, with assessments for randomization at month 7 based on disease stability criteria. Data were retrospectively analyzed to identify predictors of early visual improvements.
5:Data Analysis Methods:
Kaplan-Meier method for time to endpoints, log-rank test for comparisons, with no imputation for missing values.
独家科研数据包,助您复现前沿成果,加速创新突破
获取完整内容