Actively Recruiting
A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Led by Complement Therapeutics · Updated on 2026-06-08
75
Participants Needed
12
Research Sites
13 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are conducting a non-interventional, observational study to understand the short-term progression of geographic atrophy (GA) caused by age-related macular degeneration (AMD) in people aged 55 and older. The study aims to identify participants with progressing GA to measure structural and functional changes and explore how these relate to genetic or lifestyle factors. This research is sponsored by Complement Therapeutics and involves multiple centers. Participants with confirmed bilateral GA secondary to AMD will be observed without receiving any study treatment. The study uses imaging techniques such as fundus autofluorescence (FAF) and optical coherence tomography (OCT) to assess GA lesion size and progression. Evaluations occur at the start, 3 months, and 6 months to monitor changes in GA area and related functional vision measures. During the study, participants will undergo visual acuity tests, microperimetry to measure retinal sensitivity, and imaging scans to track GA progression. Researchers will also collect and analyze genetic and lifestyle data to understand factors influencing the disease. The primary outcome focuses on short-term GA progression measured at baseline, month 3, and month 6. The total study duration and safety monitoring details are based on these scheduled visits.
CONDITIONS
Brief Title
A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be aged 55 years or older at the time of signing informed consent.
- Participants must have bilateral geographic atrophy secondary to AMD confirmed by imaging, with at least one eye having a GA lesion area between 1.25 mm2 and 17.5 mm2.
- Best-corrected visual acuity (BCVA) in both eyes should be 20/400 or better.
- BCVA must be between 20 and 75 letters and low luminance visual acuity greater than 0 letters using an ETDRS chart.
- Mean retinal sensitivity measured by microperimetry must be 5 dB or higher.
- Able and willing to provide signed informed consent and perform all study assessments as judged by the investigator.
You will not qualify if you...
- Macular atrophy caused by conditions other than AMD in the study eye.
- Any macular pathology other than GA secondary to AMD and related early, intermediate, or atrophic AMD changes.
- Evidence of prior or current wet-AMD (choroidal neovascularization) in either eye.
- Atrophic retinal diseases other than AMD including genetic macular dystrophies, myopia-related maculopathy, and Stargardt disease.
- History of vitrectomy in the study eye.
- Any prior treatment for AMD or intravitreal treatment except oral vitamin/mineral supplements.
- Recent intraocular surgery (except cataract surgery within 6 months) or thermal laser within 3 months before screening.
- Any macular or retinal surgery at any time in the study eye.
- Ocular or periocular infection in the 12 weeks before screening.
- History of uveitis or endophthalmitis in either eye.
- Signs of diabetic retinopathy or high HbA1c (>8) in the past 12 months.
- High myopia or hyperopia (≥6 diopters) in the study eye.
- Uncontrolled intraocular pressure or glaucomatous damage.
- Other retinal diseases or ocular disorders causing safety concerns.
- Eye conditions reducing clarity or preventing imaging, including certain cataracts.
- Aphakia or absence of posterior capsule except specific prior laser treatment.
- Medical or psychiatric conditions making follow-up unlikely or posing poor medical risk.
- Participation in other interventional clinical studies or investigational treatments for AMD within 6 months.
- Abnormal lab tests deemed clinically significant.
- Hypersensitivity to medications used in standard care procedures.
- Medications associated with macular or retinal damage or optic nerve damage.
- Previous gene or cell therapy treatments.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 6 months
Participants undergo imaging and assessments to observe geographic atrophy progression.
3 visits at Baseline, Month 3, and Month 6
Trial Site Locations
Total: 12 locations
1
Northern California Retina Vitreous Associates Medical Group
Mountain View, California, United States, 94040
Actively Recruiting
2
Midwest Eye Institute
Carmel, Indiana, United States, 46032
Actively Recruiting
3
Sierra Eye Associates
Reno, Nevada, United States, 89502
Actively Recruiting
4
Mid Atlantic Retina
Bethlehem, Pennsylvania, United States, 18017
Actively Recruiting
5
Retina Foundation of the Southwest
Dallas, Texas, United States, 75231
Actively Recruiting
6
Gundersen Health System
La Crosse, Wisconsin, United States, 54601
Actively Recruiting
7
Gloucestershire Royal Hospital
Gloucester, Gloucester, United Kingdom, GL1 3NN
Actively Recruiting
8
Moorfields Eye Hospital
London, London, United Kingdom, EC1V 2PD
Actively Recruiting
9
Central Middlesex Hospital
London, London, United Kingdom, NW10 7NS
Actively Recruiting
10
University Hospital Southampton
Southampton, Southampton, United Kingdom, SO16 6YD
Actively Recruiting
11
Sunderland Eye lnfirmary
Sunderland, Sunderland, United Kingdom, SR2 9HP
Actively Recruiting
12
The Retina Clinic London
London, United Kingdom, W1G 7LB
Actively Recruiting
Research Team
M
Muhammad Ali Memon
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
0
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