A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA) (NCT07144137) | Clinical Trial Compass
RecruitingNot Applicable
A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA)
United States75 participantsStarted 2025-07-30
Plain-language summary
This is a non-interventional, observational study to provide insights into the short-term progression of GA secondary to AMD in participants aged ≥55 years.
This is a multi-center, non-interventional, observational study which aims to identify participants who have progressive GA to allow quantification of structural and functional parameters that characterize the progression of GA, and to investigate whether these correlate with genetic or lifestyle factors.
Who can participate
Age range55 Years
SexALL
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Inclusion criteria
✓. Participants must be aged ≥55 years, at the time of signing the informed consent at the screening visit.
✓. Participants with bilateral GA secondary to AMD as confirmed by the Central Reading Center using FAF and/or OCT images with at least 1 eye having a total GA lesion area must be between 1.25 mm2 and 17.5 mm2 inclusive, determined by FAF images taken at the screening visit.
✓. Best-corrected visual acuity (BCVA) in both eyes should be sufficient to ensure navigational vision (defined as 20/400 or better for purposes of this study).
✓. BCVA between 20 and 75 letters and LLVA\>0 letters using an ETDRS chart.
✓. Mean retinal sensitivity as measured by microperimetry using the study grid must be equal to or greater than 5 dB.
✓. Able and willing to provide signed informed consent which includes compliance with the requirements and restrictions listed in the informed consent form (ICF) and in this protocol, and in the opinion of the investigator, is able to perform all study assessments.
Exclusion criteria
✕. Macular atrophy secondary to any condition other than AMD in the study eye.
✕. Any pathology of the macula other than GA secondary to AMD and other changes consistent with early, intermediate or atrophic AMD in the study eye.
✕. Evidence of prior or current Choroidal Neovascularization (CNV), also known as wet-AMD, in either eye.
✕. Atrophic retinal disease of causality other than AMD including monogenetic macular dystrophies (incorporating pattern dystrophy), myopia-related maculopathy and Stargardt disease in the study eye.
✕. Any prior treatment for AMD or any prior intravitreal treatment for any indication in the study eye, except oral supplements of vitamins and minerals such as the age-related eye disease study (AREDS) formula.
✕. Any intraocular surgery (except cataract surgery within 6 months of enrollment) or thermal laser within 3 months of screening, or any ophthalmic condition that may require surgery during the study.
✕. Any macular laser, macular surgery or retinal surgery at any time point in the study eye.