Outer Retinal Tubulation and Geographic Atrophy: A Natural History Analysis of Sham Observed Eyes from the OAKS and DERBY Trials.

IF 3.2 3区医学 Q2 OPHTHALMOLOGY

Ophthalmology and Therapy Pub Date : 2025-07-01 Epub Date: 2025-05-19 DOI:10.1007/s40123-025-01156-5

Srinivas Sadda, Kensington A Hatcher, Birva K Shah, Srinivas Sai Kondapalli, Chao Li, Caroline R Baumal

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引用次数: 0

Abstract

Introduction: Retrospective, longitudinal analysis of sham observed eyes from the phase 3 OAKS and DERBY trials evaluated the relationship between geographic atrophy (GA) growth and the presence or absence of outer retinal tubulation (ORT).

Methods: Prevalence rates of ORT were calculated, and analysis of GA growth was performed using fundus autofluorescence and optical coherence tomography (OCT).

Results: ORT prevalence rates were 32%, 37.5%, and 43% at baseline, month 12, and month 24, respectively. Eyes with a fully formed ORT at baseline had 23.6% less GA area growth over 24 months compared with GA without ORT present at baseline.

Conclusion: The presence of ORT at baseline on OCT may be reflective of slower growth of GA, irrespective of GA location, as was noted in this series. The potential diagnostic impact of ORT should be considered when designing clinical studies for GA and when analyzing the results of such studies.

Trial registration: OAKS: ClinicalTrials.gov identifier NCT03525613 (registered May 15, 2018); EudraCT identifier 2018-001435-52 (registered September 27, 2018).

Derby: ClinicalTrials.gov identifier NCT03525600 (registered May 15, 2018); EudraCT identifier 2018-001436-22 (registered September 21, 2018).

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视网膜外管和地理萎缩：从OAKS和DERBY试验中观察到的假眼睛的自然历史分析。

简介：对3期OAKS和DERBY试验中假眼观察的回顾性、纵向分析评估了地理萎缩（GA）生长与视网膜外管（ORT）存在或不存在之间的关系。方法：计算ORT的患病率，并利用眼底自体荧光和光学相干断层扫描（OCT）分析GA生长情况。结果：在基线、12个月和24个月，ORT患病率分别为32%、37.5%和43%。在24个月内，基线时完全形成ORT的眼睛与基线时没有ORT的眼睛相比，GA面积的增长减少了23.6%。结论：正如本系列所述，OCT基线时ORT的存在可能反映GA生长较慢，而与GA位置无关。在设计GA临床研究和分析此类研究结果时，应考虑ORT的潜在诊断影响。试验注册：OAKS: ClinicalTrials.gov识别码NCT03525613（2018年5月15日注册）；草案标识符2018-001435-52（2018年9月27日注册）。Derby: ClinicalTrials.gov标识符NCT03525600（注册于2018年5月15日）；草案标识符2018-001436-22（2018年9月21日注册）。

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来源期刊

Ophthalmology and Therapy OPHTHALMOLOGY-

CiteScore

4.20

自引率

3.00%

发文量

157

审稿时长

6 weeks

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