A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA)
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age55+
SponsorComplement Therapeutics
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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.
Trial population
Male or female participants, aged ≥55 years, with GA secondary to AMD are considered the appropriate population. This represents the lower end of the age range for the population with GA secondary to AMD with appropriately advanced disease to enable the measurement of disease progression. Participants with bilateral GA are selected to minimize the risk of developing neovascular (wet) AMD during the study and to allow the collection of data and potential comparison of progression for 2 eyes for each participant.
Trial design
Design model
Case-only
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
No trial groups listed
Trial outcomes
Primary outcomes
1
Short-term GA Progression
To quantify the structural and functional parameters of short-term progression of geographic atrophy (GA) through clinical evaluation and investigations
Time frame
Baseline, Month 3, Month 6Secondary outcomes
1
Further exploration of GA progression
To further explore selected potential correlates of structural and functional parameters of GA progression in greater depth
Time frame
Baseline, Month 3, Month 6Sponsors and contacts
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Source ClinicalTrials.gov