1. A systematic review of real-world evidence of the management of macular oedema secondary to branch retinal vein occlusion
- Author
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Leah N Kim, Daniel Barthelmes, Sarah Ah-Moye, Mark C Gillies, Vuong Nguyen, Juan Lyn Ang, Adrian Hunt, Hemal Mehta, University of Zurich, and Mehta, Hemal
- Subjects
Vascular Endothelial Growth Factor A ,10018 Ophthalmology Clinic ,medicine.medical_specialty ,Visual acuity ,genetic structures ,Angiogenesis Inhibitors ,610 Medicine & health ,Macular oedema ,Review Article ,Therapeutics ,Real world evidence ,Macular Edema ,2809 Sensory Systems ,03 medical and health sciences ,0302 clinical medicine ,Quality appraisal ,Ranibizumab ,Ophthalmology ,Retinal Vein Occlusion ,medicine ,Humans ,Adverse effect ,business.industry ,2731 Ophthalmology ,medicine.disease ,Retinal diseases ,Checklist ,Bevacizumab ,Treatment Outcome ,Outcomes research ,Baseline characteristics ,Intravitreal Injections ,030221 ophthalmology & optometry ,Branch retinal vein occlusion ,medicine.symptom ,business ,030217 neurology & neurosurgery - Abstract
This review assessed the real-world evidence of the management of macular oedema secondary to branch retinal vein occlusion (BRVO). A meta-analysis of 2530 eyes from 48 real-world studies of therapies for macular oedema secondary to BRVO was conducted. Baseline characteristics, visual, anatomical and safety outcomes were recorded. The weighted mean and weighted estimates from random-effects models were calculated for visual acuity (VA) and central subfield thickness (CST) changes at 6, 12 and 24 months. Primary outcome was change in VA (logMAR letters) at 12 months. Study quality was assessed using the quality appraisal checklist for case series developed by Institute of Health Economics. The mean baseline VA for the pooled data was 54.0 (51.5, 56.5) letters and the mean baseline CST was 501.3 (483.5, 519.1) µm. The random-effects estimate for mean (95% CI) change in VA was 14.6 (12.5, 16.7) letters at 12 months (n = 1727). The random-effects estimate for mean (95% CI) change in CST was -181.7 (-230.7, -132.7) µm at 12 months (n = 1325). The quality of studies varied considerably. Ocular and systemic adverse events were discussed in 79% and 42% of treatment arms respectively, with possible under-reporting. Visual and anatomical gains achieved in the real-world for anti-VEGF therapy were not as impressive as seminal RCTs, possibly due to reduced injection frequency in the real world and differences in baseline characteristics. There is an urgent need for consensus on the minimum efficacy, treatment burden and safety data to collect to strengthen the real-world evidence base.摘要: 本文评估了视网膜分支静脉阻塞 (branch retinal vein occlusion, BRVO) 继发黄斑水肿的真实世界治疗证据。我们对来自48项BRVO继发黄斑水肿治疗研究的2530只眼进行了荟萃分析, 记录了基线特征、视力、解剖及安全性结果。另外于6、12、24个月时分别计算随机效应模型的视觉敏锐度 (visual acuity, VA) 和黄斑中心区视网膜厚度 (central subfield thickness, CST) 加权平均值及加权估计值的变化。研究的主要疗效指标为12个月时VA(logMAR 字母数)的改变。研究质量采用卫生经济学研究所开发的病例系列质量评估表进行评估。数据集中后平均基线视力为54.0 个(51.5, 56.5)字母, CST平均基线为501.3 (483.5, 519.1) µm。随机效应估计在第12个月 (n = 1727) 时VA平均 (95% CI) 变化的字母数为14.6 (12.5, 16.7) 个字母, 在12个月 (n = 1325) 时随机效应估计CST平均 (95% CI) 变化的值为-181.7 (−230.7, −132.7) µm。这些研究的质量差异很大。分别有79%和42%的治疗组讨论了眼部和全身不良反应, 但可能存在漏报。抗VEGF疗效在真实世界中视力和解剖方面的预后不如随机对照试验, 可能是由于真实世界中注射频率降低以及在基线特征方面存在差异。如今迫切需要在收集最低疗效、治疗负担和安全性数据上达成共识, 以便加强现实世界的证据基础。.
- Published
- 2020
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