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Study of ONL1204 eye injections to slow vision loss in patients with age-related macular degeneration and geographic atrophy

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on patients with Geographic Atrophy, a severe form of Age-related Macular Degeneration (AMD). AMD is an eye condition that causes progressive damage to the central part of the retina, leading to vision loss in the center of the field of vision. Geographic Atrophy is the advanced form of dry AMD, where patches of retinal tissue gradually deteriorate.

The study will test a new medication called ONL1204, which is given as an injection directly into the eye (intravitreal injection). Some participants will receive ONL1204, while others will receive a sham injection. The purpose is to determine if ONL1204 can slow down the progression of Geographic Atrophy in people with AMD.

During the study, participants will receive multiple eye injections over a period of 60 days. The total amount of medication given will not exceed 1200 micrograms. Throughout the study, doctors will monitor changes in the areas of retinal damage to assess how well the treatment is working.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial screening

    Your eligibility for the study will be evaluated based on the following criteria:

    You must be 55 years or older

    You must have non-foveal geographic atrophy (a specific type of age-related macular degeneration) in the study eye

    Your vision must meet specific requirements: at least 24 letters on the vision test chart for the study eye, and at least 19 letters for the other eye

  2. Step 2

    Treatment assignment

    You will be randomly assigned to receive either:

    ONL1204 Ophthalmic Solution - a medication given as an eye injection

    Or

    Sham injection - a procedure that simulates an injection but does not deliver actual medication

  3. Step 3

    Treatment administration

    The treatment will be given through intravitreal injection (an injection into the eye)

    If you are currently taking eye supplements (AREDS2 or similar), you will continue taking them throughout the study

    If you are not taking these supplements, you will continue without them during the study

  4. Step 4

    Study duration

    The study is expected to run from June 2025 to January 2028

    During this period, your eye condition will be monitored to assess how the area of geographic atrophy changes

Who can join the trial?

6 criteria

  • Must be 55 years of age or older at the time of screening
  • If currently taking AREDS2 supplements (special eye health vitamins), must agree to continue taking them throughout the study. If not taking them, must agree not to start during the study
  • Must have non-foveal geographic atrophy (an advanced form of age-related macular degeneration that does not affect the center of vision) in the study eye, without evidence of exudative macular neovascularization (abnormal blood vessel growth)
  • Must have a Best Corrected Visual Acuity (BCVA) of at least 24 letters when tested using special eye charts (ETDRS charts) in the eye being studied
  • Must have a Best Corrected Visual Acuity (BCVA) of at least 19 letters when tested using special eye charts (ETDRS charts) in the other eye
  • Both men and women may participate in the study

Who cannot join the trial?

14 criteria

  • History of any eye surgery (except cataract surgery) within 3 months before starting the study
  • Active eye infection or inflammation
  • Presence of other serious eye conditions that could affect vision
  • Previous participation in other clinical trials within 30 days
  • Known allergies to medications similar to the study drug
  • Uncontrolled high blood pressure (blood pressure consistently above normal levels despite treatment)
  • Pregnancy or planning to become pregnant during the study period
  • History of stroke (sudden loss of brain function due to blocked or ruptured blood vessels) within the past 6 months
  • Active or recent cancer treatment within the past 3 months
  • Severe health conditions that could interfere with study participation
  • Unable to provide informed consent or follow study procedures
  • Current drug or alcohol abuse
  • Taking medications that could interact with the study drug
  • Any condition that the study doctor believes would make participation unsafe
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Investigated drugs

ONL1204 is an investigational medication being studied for treating geographic atrophy (GA), a severe form of age-related macular degeneration (AMD) that can lead to vision loss. The medication is administered through injections and is designed to help slow down or prevent the progression of geographic atrophy in patients with AMD. This is a new treatment being tested to potentially help preserve vision in people affected by this condition. The trial also includes sham injections as a control measure, which means some participants receive a simulated procedure without actual medication to compare the effectiveness of ONL1204.

What is already known about the treatment

ONL1204 – An investigational medication being studied in clinical trials for the treatment of Geographic Atrophy (GA) associated with Age-related Macular Degeneration (AMD), administered through ocular injections. This novel therapeutic agent is currently undergoing Phase 2 clinical trials to evaluate its efficacy and safety compared to sham injections in patients with GA, a severe form of AMD that leads to vision loss. While the exact molecular mechanism is still being studied in clinical trials, ONL1204 is being developed as a potential treatment option for slowing the progression of geographic atrophy in patients with age-related macular degeneration, representing a new approach in ophthalmological medicine.

Investigated diseases

Age-related Macular Degeneration (AMD) - A progressive eye condition that affects the central part of the retina called the macula. The disease exists in two forms, with the atrophic (dry) form characterized by the gradual breakdown of light-sensitive cells in the macula. In atrophic AMD, small yellow deposits called drusen develop under the retina, and the macula slowly thins and degenerates over time. This leads to the development of geographic atrophy (GA), where patches of retinal tissue deteriorate, creating areas of vision loss in the central field of vision. The condition typically develops gradually over several years, primarily affecting people over the age of 50. Vision changes occur slowly, with affected individuals experiencing increasing difficulty with detailed tasks like reading or recognizing faces.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-513174-22-00Protocol codeONL1204-GA-002Estimated enrolment324 patientsSponsorONL Therapeutics Inc.

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