Study on the Effectiveness and Safety of GAL-101 Eye Drops for Patients with Geographic Atrophy from Age-Related Macular Degeneration

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What is this study about?

This clinical trial is focused on studying a condition called non-foveal geographic atrophy, which is a type of damage to the retina that occurs in some people with age-related macular degeneration (AMD). AMD is a common eye condition that can lead to vision loss in older adults. The study is testing a new treatment called GAL-101, which is an eye drop solution. The purpose of the study is to see if GAL-101 can help slow down the progression of the retinal damage in people with this condition.

Participants in the study will be randomly assigned to receive either the GAL-101 eye drops or a matching placebo, which looks like the GAL-101 solution but does not contain the active ingredient. The study is designed to be “double-masked,” meaning neither the participants nor the researchers will know who is receiving the actual treatment or the placebo. This helps ensure that the results are not biased. The study will take place over a period of time, during which participants will use the eye drops and have regular check-ups to monitor their eye health and the size of the affected area in the retina.

The main goal of the study is to evaluate how effective GAL-101 is in reducing the rate of change in the size of the damaged area in the retina. Participants will undergo various eye examinations, including a method called fundus autofluorescence (FAF), which helps visualize the retina, and optical coherence tomography (OCT), which provides detailed images of the retina. These tests will help researchers understand how the treatment affects the progression of the disease. The study aims to provide valuable information on the safety and effectiveness of GAL-101 for people with non-foveal geographic atrophy due to age-related macular degeneration.

1 joining the study

Upon joining the study, you will be randomly assigned to one of two groups. One group will receive the GAL-101 ophthalmic solution, and the other group will receive a placebo solution. The placebo looks like the GAL-101 solution but does not contain the active ingredient.

2 administration of the solution

You will be required to administer the assigned ophthalmic solution to your study eye. The solution should be applied as directed by the study team. The frequency and duration of administration will be explained to you during your initial visit.

3 regular study visits

You will need to attend regular study visits at the clinic. During these visits, the study team will perform various assessments to monitor your eye health and the effects of the treatment. These assessments may include imaging tests and vision tests.

4 monitoring and assessments

Throughout the study, your eye health will be closely monitored. The primary focus will be on the change in the size of the geographic atrophy (GA) area in your eye. This will be measured using a special imaging technique called fundus autofluorescence (FAF).

Secondary assessments will include measuring changes in the area of photoreceptor degeneration (PRD) using optical coherence tomography (OCT) and changes in vision sensitivity using mesopic microperimetry (MP).

5 completion of the study

The study is expected to continue until November 2025. Upon completion, the study team will review all collected data to evaluate the efficacy and safety of the GAL-101 ophthalmic solution.

Who Can Join the Study?

Must be 55 years of age or older.
Willing and able to provide written informed consent (agreeing to participate after understanding the study).
Willing and able to follow the study schedule and assessments (appointments and tests).
Able to use the eye drop solution or have someone who can help, like a family member or healthcare professional.
Have a vision score of 50 letters or more in the study eye, which is similar to reading the 20/100 line on an eye chart.
Have a refractive error (need for glasses or contact lenses) between +3 and -6 diopters in the study eye.
Have clear eye media (parts of the eye that light passes through) and good pupil dilation for quality eye imaging, as judged by the study doctor.
Willing and able to complete MP testing (a specific eye test) for the study eye, as judged by the study doctor and verified by the reading center.
Diagnosed with non-foveal geographic atrophy (a specific type of eye condition) due to non-neovascular age-related macular degeneration in the study eye, confirmed by the reading center. This includes:
- A well-defined geographic atrophy area between 1.25 and 12.0 mm².
- If there are multiple areas, at least one must be 1.25 mm² or larger.
- Geographic atrophy areas must be located outside a 100 µm radius from the center of the fovea (the central part of the retina).
- Geographic atrophy areas must be located within a 2000 µm radius from the center of the fovea.
- Geographic atrophy areas must be completely within the imaging field used for the study.
- Geographic atrophy areas must be 300 µm or more from the optic disc and/or areas of peripapillary atrophy (areas around the optic nerve).
- The area of PRD (a specific measurement related to the eye condition) must be between 5.0 and 25.0 mm².

Who Cannot Join the Study?

Patients with non-foveal geographic atrophy caused by non-neovascular age-related macular degeneration cannot participate. This means if the damage to the eye is not in the central part of the retina and is not caused by new blood vessel growth, you cannot join.
Patients who are not within the specified age range for the study cannot participate.
Patients who are part of a vulnerable population, such as those unable to give consent, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Medizinische Hochschule Hannover	Hanover	Germany
Universitaetsklinikum Heidelberg AöR	Heidelberg	Germany

Other Sites

Site Name	City	Country
Centre Monticelli Paradis D Ophtalmologie	Marseille	France
Multimedica S.p.A.	Milan	Italy
Fondazione G.B.Bietti Per Lo Studio E La Ricerca In Oftalmologia	Rome	Italy
Institute Of Eye Surgery Limited	Waterford	Ireland
Diakonie Klinikum Dietrich Bonhoeffer GmbH	Neubrandenburg	Germany
Institute of Eye Surgery – UPMC Kildare Hospital	Clane	Ireland
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Ospedale San Raffaele S.r.l.	Milan	Italy
Rheinische Friedrich-Wilhelms-Universitaet Bonn	Bonn	Germany
Medical Center – University Of Freiburg	Freiburg Im Breisgau	Germany
Institut fuer Klinische Transfusionsmedizin und Immungenetik Ulm gGmbH	Ulm	Germany
Selarl Retine Tourny	Bordeaux	France
Centre Ophtalmologique Saint Exupéry	Saint-Cyr-Sur-Loire	France
Centre Ophtalmologique de l’Odéon	Paris	France
Cpx Csupc Rkmtlvqmlvh	Lyon	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	30.04.2025
Germany	Recruiting	30.04.2025
Ireland	Recruiting	30.04.2025
Italy	Recruiting	30.04.2025

Trial locations

Investigated drugs:

SODIUM (R)-2-(2-AMINO-3-(1H-INDOL-3- YL)PROPANAMIDO)-2-METHYLPROPANOATE-PROPAN-2-OL

GAL-101 is an eye drop solution being tested to see if it can help slow down the worsening of a specific eye condition called geographic atrophy, which is related to age-related macular degeneration. This condition affects the part of the eye responsible for sharp, central vision. The study is looking at how well this solution works in reducing the size of the damaged area in the eye over time. By using these eye drops, researchers hope to find a way to protect the eye and maintain vision for a longer period.

Non-foveal geographic atrophy secondary to non-neovascular age-related macular degeneration – This condition is a form of age-related macular degeneration that affects the retina, specifically outside the central fovea area. It is characterized by the progressive degeneration of retinal cells, leading to the formation of atrophic patches. These patches gradually enlarge over time, resulting in a loss of retinal tissue. The disease progresses slowly, causing a gradual decline in vision, particularly in the peripheral areas of the central vision. It does not involve the growth of new blood vessels, distinguishing it from the neovascular form of age-related macular degeneration. The condition primarily affects older adults and is a leading cause of vision impairment in this population.

Trial ID:

2024-519128-26-00

Protocol code:

GAL-101-C0201

NCT ID:

NCT06659549

Trial Phase:

Therapeutic exploratory (Phase II)

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