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 2018-002435-52 (registered September 27, 2018). DERBY: ClinicalTrials.gov identifier NCT03525600 (registered May 15, 2018)
EudraCT identifier 2018-002436-22 (registered September 21, 2018).