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

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

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, an...

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Bibliographic Details
Main Authors: Srinivas Sadda, Kensington A. Hatcher, Birva K. Shah, Srinivas Sai Kondapalli, Chao Li, Caroline R. Baumal
Format: Article
Language:English
Published: Adis, Springer Healthcare 2025-05-01
Series:Ophthalmology and Therapy
Subjects:
Biomarker
Geographic atrophy
Late age-related macular degeneration
Optical coherence tomography
Outer retinal tubulation
Online Access:https://doi.org/10.1007/s40123-025-01156-5
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Summary: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).
ISSN:2193-8245
2193-6528

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