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New eye drops aim to halt blinding disease in seniors

NCT ID NCT06659549

Disease control Sponsor: Galimedix Therapeutics Inc Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Aug 21, 2026 · Updated 6 times

Summary

This study tests whether GAL-101 eye drops can slow the growth of geographic atrophy, a form of advanced age-related macular degeneration that causes blind spots. About 110 adults aged 55 and older with early-stage atrophy will use the drops or a placebo daily for up to two years. The goal is to see if the treatment can keep the damage from reaching the center of vision.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
GAL-101 eye drops
What this could lead to
If successful, this could slow vision loss from geographic atrophy and help preserve central vision in elderly patients.
What could go wrong
This is an early Phase 2 trial with only 110 participants. The drug may not slow atrophy growth, and daily eye drops may be inconvenient or cause irritation.

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.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 110 people

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

Started

Jan 2025

Expected to finish

May 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.

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 Criteria: * ≥55 years of age * Willing and able to provide written informed consent * Willing and able to comply with the study schedule and study assessments * Able to successfully administer ophthalmic solution or have an appropriate designee (e.g., family member, health care professional) who can administer ophthalmic solution * BCVA of ≥50 letters in the study eye using Early Treatment Diabetic Retinopathy Study (ETDRS) chart (i.e., 20/100 Snellen equivalent). Criterion will be confirmed at Baseline * Refractive error between +3 and -6 diopters spherical equivalent in the study eye * Sufficiently clear ocular media and adequate pupillary dilation to permit quality fundus imaging of the study eye, in the opinion of the Investigator. Criterion will be confirmed at Baseline * Diagnosed with non-foveal GA secondary to non-neovascular AMD in the study eye, as confirmed by the reading center 1. Well-delineated cumulative GA area between 1.25 and 12.0 mm2 2. If GA is multifocal, at least 1 lesion ≥1.25 mm2 3. GA lesions must be located outside a ≥100 µm radius from the center point of the fovea (i.e., this area must have intact retinal pigment epithelium \[RPE\] and outer retina) 4. GA lesions must be located (partially or wholly) within a 2000 µm radius from the center point of the fovea 5. GA lesions must be completely located within FAF imaging field (field 2 to 30-degree image centered on the fovea). GA lesion borders must be \>300 µm from image edges 6. GA lesions must be \>300 µm from the optic disc and/or peripapillary atrophy 7. Area of PRD must be cumulatively between 7.25 and 25.0 mm2 Exclusion Criteria: 1. Presence or history of choroidal neovascularization (CNV). Criterion will be confirmed at Baseline 2. History of laser therapy in the macular region, regardless of indication 3. History of herpes zoster 4. Ophthalmic disease or condition that requires or is likely to require surgery during the study period 5. GA with cumulative area \<1.25 mm2 6. Any GA lesion within 100 µm radius from the center point of the fovea 7. Axial length \>26 mm 8. Any ocular disease or condition other than non-neovascular AMD that may, in the opinion of the Investigator, interfere with study assessments, patient adherence to the study schedule, or interpretation of study data (e.g., epiretinal membrane, macular hole, glaucomatous optic neuropathy, etc.) 9. Intraocular surgery (including cataract extraction and crystalline lens replacement) within 3 months before Visit 1a or yttrium aluminum garnet (YAG) surgery within 2 months before Visit 1a, or planned either during the study period 10. Use of pegcetacoplan or avacincaptad pegol within 6 months before Visit 1a, or planned use during the study period 11. Use of any prescription or over-the-counter ophthalmic medication within 1 month before Visit 1a or planned use during the study period 12. Use of rigid contact lenses within 1 month before Visit 1a or planned use during the study period Non-study Eye: 13. BCVA of \<5 letters using ETDRS chart (i.e., 20/800 Snellen equivalent) Either Eye: 14. History of uveitis 15. GA secondary to any condition other than non-neovascular AMD 16. History of active ocular infection or inflammation within 3 months before Visit 1a or Baseline. Criterion will be confirmed at Baseline 17. Underwent investigational treatment for AMD within 6 months before Visit 1a General Exclusion Criteria: 18. History of therapeutic radiation to the cranium 19. Known allergy or hypersensitivity to the investigational medicinal product (IMP) or any of its excipients 20. History of malignant disease 21. Use of hydroxychloroquine within 1 month before Visit 1a, or planned use during the study period 22. Participated or plan to participate in any other IMP study within 1 month before Visit 1a or during the study period 23. Use of lutein \>10 mg per day or zeaxanthin \>2 mg per day within 1 month before Visit 1a, or planned use during the study period 24. Any medical condition (including mental), in the opinion of the Investigator, that could interfere with study assessments, patient adherence to the study schedule, or interpretation of study data 25. Screening laboratory values, in the opinion of the Investigator, that make the patient unsuitable for study participation 26. Pregnant, nursing, or planning a pregnancy during the study. Criterion will be confirmed at Baseline 27. Unwilling or unable to use an acceptable method of contraception throughout the study if a woman of childbearing potential (WOCBP) or if a sexual partner of a WOCBP

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Conditions

The condition(s) this trial relates to.

age-related macular degeneration dry age related macular degeneration Geographic Atrophy macular degeneration Plaque, Amyloid

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Geographic atrophy of the macula

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

    24 sites in 8 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 and phone numbers. 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: •••••@•••••

  • Contact

    Email: •••••@•••••

Locations

  • Akhali Mzera Limited

    RECRUITING

    Tbilisi, 0162, Georgia

  • Bay Area Retina Associates

    RECRUITING

    Walnut Creek, California, 94598, United States

  • Caucasus Medical Centre LLC

    RECRUITING

    Tbilisi, 0186, Georgia

  • Centre Monticelli Paradis d'Ophtalmologie

    RECRUITING

    Marseille, 13008, France

  • Centre Ophtalmologique Odéon

    NOT_YET_RECRUITING

    Paris, 75006, France

  • Centre Rétine Gallien

    RECRUITING

    Bordeaux, 33000, France

  • Centre médico-chirurgical de Touraine

    RECRUITING

    Tours, 37540, France

  • Chichua Medical Centre Mzera LLC

    WITHDRAWN

    Tbilisi, Georgia

  • Cumberland Valley Retina Consultants

    SUSPENDED

    Hagerstown, Maryland, 21740, United States

  • Dietrich Bonhoeffer Klinikum

    RECRUITING

    Neubrandenburg, 17036, Germany

  • Hadassah Medical Center

    RECRUITING

    Jerusalem, 9112001, Israel

  • Hopital de La Croix-Rousse Service D'Ophtalmologie Groupement Hospitalier Nord Hospices Civils de Lyon

    RECRUITING

    Lyon, 69317, France

  • Institute of Eye Surgery (IOES Waterford)

    RECRUITING

    Waterford, X91 DH9W, Ireland

  • Medical Retina & Imaging Unit, IRCCS MultiMedica, Ospedale San Giuseppe

    RECRUITING

    Milan, Milano, 20123, Italy

  • Medizinische Hochschule Hannover Augenklinik

    NOT_YET_RECRUITING

    Hanover, 30625, Germany

  • Ophthalmological Center After S.V. Malayan

    RECRUITING

    Yerevan, 0048, Armenia

  • Retina-Vitreous Associates Medical Group

    RECRUITING

    Beverly Hills, California, 90211, United States

  • Tel Aviv Medical Center

    RECRUITING

    Tel Aviv, 6423906, Israel

  • UNIVERSITÄTSKLINIKUM ULM Klinik für Augenheilkunde

    NOT_YET_RECRUITING

    Ulm, 89075, Germany

  • UOS Retina Medica, P.O. Britannico, IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in OftalmologiaUOS Retina Medica, P.O. Britannico, IRCCS Fondazione G.B. Bietti per lo Studio e la Ricerca in Oftalmologia

    RECRUITING

    Roma, Roma, 00184, Italy

  • UPMC Kildare Hospital Prosperous Rd Clane, Kildare Ireland

    NOT_YET_RECRUITING

    Kildare, W91 W535, Ireland

  • Unità di Oculistica, IRCCS Ospedale San Raffaele

    RECRUITING

    Milan, Milano, 20132, Italy

  • Universitäts-Augenklinik Bonn

    RECRUITING

    Bonn, 53127, Germany

  • Universitätsklinikum Freiburg Klinik für Augenheilkunde

    RECRUITING

    Freiburg im Breisgau, 79106, Germany

  • Universitätsklinikum Tübingen, Department für Augenheilkunde.

    NOT_YET_RECRUITING

    Tübingen, 72076, Germany

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