New study tracks eye disease progression in older adults
NCT ID NCT07144137
First seen Jun 27, 2026 · Last updated Sep 04, 2026 · Updated 8 times
Summary
This study observes 75 adults aged 55 and older with geographic atrophy (a late stage of age-related macular degeneration) to see how the condition progresses over a short time. Researchers will measure changes in eye structure and function, and explore links to genetics and lifestyle. No treatment is given—the goal is to better understand the disease.
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Study facts
What this study's own registry entry says, in plain language.
- Participants
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About 75 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Jun 2027
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
Who is studied
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.
- Ages
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55 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion: 1. Participants must be aged ≥55 years, at the time of signing the informed consent at the screening visit. 2. 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. 3. 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). 4. BCVA between 20 and 75 letters and LLVA\>0 letters using an ETDRS chart. 5. Mean retinal sensitivity as measured by microperimetry using the study grid must be equal to or greater than 5 dB. 6. 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: 1. Macular atrophy secondary to any condition other than AMD in the study eye. 2. 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. 3. Evidence of prior or current Choroidal Neovascularization (CNV), also known as wet-AMD, in either eye. 4. 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. 5. A history of vitrectomy in the study eye. 6. 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. 7. 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. 8. Any macular laser, macular surgery or retinal surgery at any time point in the study eye. 9. Any ocular or periocular infection in the 12 weeks prior to screening. 10. History of uveitis or endophthalmitis in either eye. 11. Any sign of diabetic retinopathy in either eye, or HbA1c \>8, in the 12 months prior to enrollment. 12. High myopia or hyperopia (≥6 diopter) in the study eye. 13. 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. 14. 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). 15. 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. 16. 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. 17. 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. 18. 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. 19. 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. 20. Hypersensitivity to medications used in (standard of care) study procedures. 21. 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). 22. 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: 23. Any previous gene or cell therapy (ophthalmic or systemic), 24. 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
15 sites in 2 countries. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Genom att skicka in godkänner du våra Användarvillkor
Study contacts
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Contact
Email: •••••@•••••
Locations
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Belfast City Hospital
RECRUITINGBelfast, BT9 7AB, United Kingdom
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Central Middlesex Hospital
RECRUITINGLondon, London, NW10 7NS, United Kingdom
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Duke Eye Center
RECRUITINGDurham, North Carolina, 27710, United States
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Frimley Park Hospital
RECRUITINGFrimley, GU16 7UJ, United Kingdom
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Gloucestershire Royal Hospital
RECRUITINGGloucester, Gloucester, GL1 3NN, United Kingdom
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Gundersen Health System
RECRUITINGLa Crosse, Wisconsin, 54601, United States
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Manchester Royal Eye Hospital
RECRUITINGManchester, M13 9WL, United Kingdom
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Mid Atlantic Retina
RECRUITINGBethlehem, Pennsylvania, 18017, United States
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Midwest Eye Institute
WITHDRAWNCarmel, Indiana, 46032, United States
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Moorfields Eye Hospital
RECRUITINGLondon, London, EC1V 2PD, United Kingdom
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Northern California Retina Vitreous Associates Medical Group
ACTIVE_NOT_RECRUITINGMountain View, California, 94040, United States
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Retina Foundation of the Southwest
RECRUITINGDallas, Texas, 75231, United States
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Sierra Eye Associates
RECRUITINGReno, Nevada, 89502, United States
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Sunderland Eye lnfirmary
RECRUITINGSunderland, Sunderland, SR2 9HP, United Kingdom
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The Retina Clinic London
RECRUITINGLondon, W1G 7LB, United Kingdom
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University Hospital Southampton
RECRUITINGSouthampton, Southampton, SO16 6YD, United Kingdom
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University Retina and Macula Associates
RECRUITINGOak Forest, Illinois, 60452, United States
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