NCT07144137Recruiting
A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA)
A Non-Interventional Study Observing Short-Term Progression in Geographic Atrophy (GA) Secondary to Age-Related Macular Degeneration (AMD)
Source: ClinicalTrials.gov · Last updated 16 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 75 (estimated)
- First submitted
- 20 Aug 2025
- Start date
- Jul 2025
- Primary completion date
- Mar 2027
- Lead sponsor
- Complement Therapeutics
- Diseases
- Macular degeneration
- NCT number
- NCT07144137
What you commit to
- Study type: Observational
- Planned participants: 75
- From Jul 2025 to the primary completion date, Mar 2027
- 19 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Evidence of prior or current Choroidal Neovascularization (CNV), also known as wet-AMD, in either 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 macular laser, macular surgery or retinal surgery at any time point in the study eye.
- Any ocular or periocular infection in the 12 weeks prior to screening.
- Aphakia or absence of the posterior capsule. Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 60 days prior to baseline.
- Participation in an interventional clinical study, or use of any experimental treatment for AMD or any investigational product within 6 months or 5 half-lives of the active ingredient (whichever is longer) prior to screening.
- History or current use of medications associated with macular changes, retinal dysfunction or optic nerve damage. These include but are not limited to the following prohibited concomitant medications:
- Any previous gene or cell therapy (ophthalmic or systemic),
- Chloroquine (where taken for \>30 days cumulative across participant's lifetime), hydroxychloroquine, platinum containing medications, ethambutol, tamoxifen, pentosan, chronic use of phosphodiesterase inhibitors, and GLP-1 antagonists in the setting of a crowded optic disc.
Other illness
- Macular atrophy secondary to any condition other than AMD in the study 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.
- A history of vitrectomy in the study eye.
- 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.
- History of uveitis or endophthalmitis in either eye.
- Retinal disease other than AMD or other ocular disorders which may cause safety concerns per the judgment of the investigator; however, benign conditions of the vitreous or peripheral retina are not exclusionary (i.e., paving stone degeneration).
- Any ophthalmologic condition that reduces the clarity of the media and that, in the opinion of the investigator interferes with ophthalmologic examination (e.g., cataract or corneal abnormalities) either at the time of enrollment or during the 2-year post dosing follow-up period; or prevents adequate imaging of the retina judged by the site or CRC.
- Medical or psychiatric conditions that, in the opinion of the investigator, make consistent follow-up over the treatment period unlikely, or in general a poor medical risk because of other systemic diseases or active uncontrolled infections, including but not limited to immunodeficiency state, autoimmune diseases, malignancy other than prostate or basal cell carcinoma, connective tissue disorders and collagen vascular disorders.
- Hypersensitivity to medications used in (standard of care) study procedures.
- Situations where, in the opinion of the investigator, the risk of harm to a participant outweighs any potential benefits from study participation (these could include participants with conditions such as brittle diabetes or advanced osteoporosis as examples).
Lab values
- Any sign of diabetic retinopathy in either eye, or HbA1c \>8, in the 12 months prior to enrollment.
- History of abnormal laboratory tests (e.g. hematology, serum chemistry, renal or liver function tests, or infectious disease screen) that in the opinion of the investigator is clinically significant at the time of enrollment and not suitable for study participation.
Other
- 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.
- High myopia or hyperopia (≥6 diopter) in the study eye.
- Uncontrolled IOP measurement of ≥25 mmHg for \>1 month despite being on 2 or more ocular hypotensive agents, or IOP \>21 mm Hg in the presence of C/D asymmetry of \>0.3 per the reading center; or glaucomatous damage to the optic nerve or visual field.
Criteria the registry did not label
- Inclusion:
- 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.
Age in the registry: 55 years to - · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Belfast City Hospital Coordinator of this site? Confirm its status | Belfast | United Kingdom | Recruiting |
| Frimley Park Hospital Coordinator of this site? Confirm its status | Frimley | United Kingdom | Recruiting |
| Gloucestershire Royal Hospital Coordinator of this site? Confirm its status | Gloucester | United Kingdom | Recruiting |
| Moorfields Eye Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| The Retina Clinic London Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Central Middlesex Hospital Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
| Manchester Royal Eye Hospital Coordinator of this site? Confirm its status | Manchester | United Kingdom | Recruiting |
| University Hospital Southampton Coordinator of this site? Confirm its status | Southampton | United Kingdom | Recruiting |
| Sunderland Eye lnfirmary Coordinator of this site? Confirm its status | Sunderland | United Kingdom | Recruiting |
| Mid Atlantic Retina Coordinator of this site? Confirm its status | Bethlehem | United States | Recruiting |
| Midwest Eye Institute Coordinator of this site? Confirm its status | Carmel | United States | Withdrawn |
| Retina Foundation of the Southwest Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
| Duke Eye Center Coordinator of this site? Confirm its status | Durham | United States | Recruiting |
| Gundersen Health System Coordinator of this site? Confirm its status | La Crosse | United States | Recruiting |
| Northern California Retina Vitreous Associates Medical Group Coordinator of this site? Confirm its status | Mountain View | United States | Active, not recruiting |
| University Retina and Macula Associates Coordinator of this site? Confirm its status | Oak Forest | United States | Recruiting |
| Sierra Eye Associates Coordinator of this site? Confirm its status | Reno | United States | Recruiting |
| Springfield Clinic Coordinator of this site? Confirm its status | Springfield | United States | Recruiting |
| North Carolina Retina Associates Coordinator of this site? Confirm its status | Wake Forest | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.