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New study tracks eye disease progression in older adults

NCT ID NCT07144137

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 75 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

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

55 years and older

Sex

Anyone

Healthy volunteers

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

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.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    15 sites in 2 countries. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names. We don't republish those.

    Open the record ↗

  4. 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

Study contacts

  • Contact

    Email: •••••@•••••

Locations

  • Belfast City Hospital

    RECRUITING

    Belfast, BT9 7AB, United Kingdom

  • Central Middlesex Hospital

    RECRUITING

    London, London, NW10 7NS, United Kingdom

  • Duke Eye Center

    RECRUITING

    Durham, North Carolina, 27710, United States

  • Frimley Park Hospital

    RECRUITING

    Frimley, GU16 7UJ, United Kingdom

  • Gloucestershire Royal Hospital

    RECRUITING

    Gloucester, Gloucester, GL1 3NN, United Kingdom

  • Gundersen Health System

    RECRUITING

    La Crosse, Wisconsin, 54601, United States

  • Manchester Royal Eye Hospital

    RECRUITING

    Manchester, M13 9WL, United Kingdom

  • Mid Atlantic Retina

    RECRUITING

    Bethlehem, Pennsylvania, 18017, United States

  • Midwest Eye Institute

    WITHDRAWN

    Carmel, Indiana, 46032, United States

  • Moorfields Eye Hospital

    RECRUITING

    London, London, EC1V 2PD, United Kingdom

  • Northern California Retina Vitreous Associates Medical Group

    ACTIVE_NOT_RECRUITING

    Mountain View, California, 94040, United States

  • Retina Foundation of the Southwest

    RECRUITING

    Dallas, Texas, 75231, United States

  • Sierra Eye Associates

    RECRUITING

    Reno, Nevada, 89502, United States

  • Sunderland Eye lnfirmary

    RECRUITING

    Sunderland, Sunderland, SR2 9HP, United Kingdom

  • The Retina Clinic London

    RECRUITING

    London, W1G 7LB, United Kingdom

  • University Hospital Southampton

    RECRUITING

    Southampton, Southampton, SO16 6YD, United Kingdom

  • University Retina and Macula Associates

    RECRUITING

    Oak Forest, Illinois, 60452, United States

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