Department of Ophthalmology, Linkou Chang Gung Memorial Hospital, Taoyuan, Taiwan; College of Medicine, Chang Gung University, Taoyuan, Taiwan; Graduate Institute of Clinical Medical Sciences, College of Medicine, Chang Gung University, Taoyuan, Taiwan.
Department of Pharmacy, Keelung Chang Gung Memorial Hospital, Keelung, Taiwan; School of Pharmacy, Institute of Clinical Pharmacy and Pharmaceutical Sciences, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
Biomed J. 2024 Feb;47(1):100607. doi: 10.1016/j.bj.2023.100607. Epub 2023 May 15.
Concerns about the generalizability of pivotal randomized controlled trials (pRCTs) findings have been raised. We aimed to compare intravitreal dexamethasone implants' (IDIs) effectiveness for diabetic macular edema (DME) and central retinal vein occlusion (CRVO), between eyes eligible and ineligible for pRCTs.
This retrospective cohort study analyzed Taiwan's Chang Gung Research Database, including DME or CRVO eyes initiating IDIs during 2015-2020. We classified all treated eyes as eligible or ineligible for pRCTs following major selection criteria of the MEAD and GENEVA trials, and evaluated three-, six-, and twelve-month changes in central retinal thickness (CRT) and visual acuity (VA) after initiating IDIs.
We included 177 IDI-treated eyes (DME: 72.3%; CRVO: 27.7%), of which 39.8% and 55.1% were ineligible for DME and CRVO pRCTs, respectively. LogMAR-VA and CRT changes at different times were comparable in DME eyes eligible (LogMAR-VA difference: 0.11 to 0.16; CRT difference: -32.7 to -96.9 μm) and ineligible (LogMAR-VA difference: -0.01 to 0.15; CRT difference: -54.5 to -109.3 μm) for the MEAD trial. By contrast, CRVO eyes ineligible for the GENEVA trial had greater LogMAR-VA changes (0.37 ~ 0.50) than those eligible (0.05 ~ 0.13), with comparable CRT reductions (eligible eyes: -72.3 to -106.4 μm; ineligible eyes: -61.8 to -110.7 μm) (all p-values <0.05 of the mean differences between eligible and ineligible CRVO eyes for all follow-ups).
IDIs had similar VA and CRT outcomes among DME eyes, regardless of pRCT-eligibility. However, among CRVO eyes, those ineligible for pRCTs showed greater deterioration in VA than those eligible.
人们对关键随机对照试验（pRCTs）结果的普遍性提出了担忧。我们旨在比较玻璃体腔内注射地塞米松植入物（IDIs）治疗糖尿病性黄斑水肿（DME）和视网膜中央静脉阻塞（CRVO）的有效性，比较符合和不符合 pRCT 条件的眼睛。
这项回顾性队列研究分析了台湾长庚研究数据库中 2015 年至 2020 年间接受 IDIs 治疗的 DME 或 CRVO 眼睛。我们根据 MEAD 和 GENEVA 试验的主要选择标准，将所有接受治疗的眼睛分为符合和不符合 pRCT 条件，并评估了开始 IDIs 后三个月、六个月和十二个月中央视网膜厚度（CRT）和视力（VA）的变化。
我们纳入了 177 只接受 IDI 治疗的眼睛（DME：72.3%；CRVO：27.7%），其中 39.8%和 55.1%的眼睛不符合 DME 和 CRVO pRCT 的条件。在 DME 眼睛中，符合（LogMAR-VA 差异：0.11 至 0.16；CRT 差异：-32.7 至-96.9 μm）和不符合（LogMAR-VA 差异：-0.01 至 0.15；CRT 差异：-54.5 至-109.3 μm）MEAD 试验的眼睛，不同时间的 LogMAR-VA 和 CRT 变化相当。相比之下，不符合 GENEVA 试验条件的 CRVO 眼睛的 LogMAR-VA 变化（0.37 至 0.50）大于符合条件的眼睛（0.05 至 0.13），CRT 降低程度相当（符合条件的眼睛：-72.3 至-106.4 μm；不符合条件的眼睛：-61.8 至-110.7 μm）（所有随访中，符合和不符合条件的 CRVO 眼睛之间的平均差异的 p 值均<0.05）。
IDIs 在 DME 眼中具有相似的 VA 和 CRT 结果，无论是否符合 pRCT 条件。然而，在 CRVO 眼中，不符合 pRCT 条件的眼睛的 VA 恶化程度大于符合条件的眼睛。
