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Study on the Effectiveness and Safety of ANX007 Injections for Patients with Geographic Atrophy from Age-Related Macular Degeneration

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What is this trial about?

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

This clinical trial is focused on studying a condition called Geographic Atrophy (GA), which is a form of Age-Related Macular Degeneration (AMD). AMD is a common eye condition that affects the macula, the part of the eye responsible for clear central vision. The study is testing a treatment called ANX007, which is given as an injection directly into the eye, a method known as intravitreal injection.

The purpose of the study is to evaluate how effective and safe ANX007 is in improving visual function and clarity in patients with GA. Participants in the study will receive either the ANX007 injection or a placebo. The study will last for 24 months, during which participants will have monthly visits to monitor their progress and any side effects. The main goal is to see if ANX007 can help maintain or improve vision over time.

Throughout the study, researchers will closely observe any changes in vision and any potential side effects. The study will also track the overall safety of the treatment to ensure it is well-tolerated by participants. This research aims to provide valuable insights into the potential benefits of ANX007 for people living with GA due to AMD.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    The study begins with an initial visit where eligibility is confirmed. This includes a diagnosis of geographic atrophy related to age-related macular degeneration.

    The study eye is selected based on specific criteria, including the size and characteristics of the geographic atrophy lesion.

  2. Step 2

    Baseline assessment

    A baseline assessment is conducted to measure best corrected visual acuity (BCVA) using the ETDRS chart. This establishes a reference point for future comparisons.

  3. Step 3

    Treatment administration

    The treatment involves intravitreal injections of ANX007. This is an injection directly into the eye.

    The injections are administered monthly over a period of 24 months.

  4. Step 4

    Monthly follow-up visits

    Monthly follow-up visits are required to monitor the patient's condition and response to the treatment.

    During these visits, assessments of visual function and visual acuity are conducted.

  5. Step 5

    Primary evaluation

    The primary evaluation occurs between Month 12 and Month 18. This involves assessing the proportion of patients experiencing a significant loss in visual acuity.

  6. Step 6

    Secondary evaluation

    Secondary evaluations focus on the incidence and severity of any adverse events related to the treatment. These evaluations occur through Month 12 and Month 24.

  7. Step 7

    Study completion

    The study concludes after 24 months of treatment and monitoring. Final assessments are conducted to evaluate the overall efficacy and safety of the treatment.

Who can join the trial?

9 criteria

  • The patient must have a condition called Geographic Atrophy (GA) due to Age-Related Macular Degeneration (AMD).
  • If the patient has been receiving treatment for GA in the other eye with an approved drug for at least 3 months, they can continue this treatment. If the treatment has been for less than 3 months, they should not join the study. If the other eye has not been treated, it should not need treatment for at least the first year of the study, according to the doctor's opinion.
  • The patient must be at least 50 years old when they sign the consent form.
  • The patient must be able and willing to participate in a study that lasts 24 months, with monthly visits.
  • The patient must have a diagnosis of GA of the macula due to AMD, confirmed by a doctor and an independent reading center.
  • The GA lesion must have specific characteristics, such as a well-defined area between 2.5 mm² and 17.5 mm², and must show a pattern called hyper autofluorescence in a specific zone. The entire lesion must be visible in an image centered on the macula and not connected to another condition called peripapillary atrophy.
  • The patient must have a certain level of vision, measured by a test called BCVA, which should be between 45 to 83 letters on a specific chart. If the vision test results differ by 10 or more letters between two tests, the patient will not be eligible.
  • A female patient can join if she is not pregnant or breastfeeding and meets certain conditions, such as being unable to have children or using a highly effective birth control method. She must also have a negative pregnancy test before starting the study.
  • The patient must be able to give signed consent, agreeing to follow the study's requirements and restrictions.

Who cannot join the trial?

10 criteria

  • Patients with any other eye disease that could affect vision, apart from the condition being studied.
  • Patients who have had eye surgery in the past three months.
  • Patients with a history of severe allergic reactions to medications.
  • Patients who are currently participating in another clinical trial.
  • Patients with uncontrolled high blood pressure.
  • Patients with a history of stroke or heart attack in the past six months.
  • Patients who are pregnant or breastfeeding.
  • Patients with any serious illness that could interfere with the study.
  • Patients who have received any treatment for the condition being studied in the past three months.
  • Patients with a history of drug or alcohol abuse in the past year.
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Investigated drugs

ANX007 is a medication being studied for its potential to help patients with geographic atrophy, a condition related to age-related macular degeneration. It is administered through an injection into the eye, known as an intravitreal injection. The goal of this medication is to improve visual function and visual acuity, which means it aims to help patients see better and maintain their vision.

What is already known about the treatment

ANX007 – ANX007 is administered through intravitreal injection, which means it is injected directly into the eye. It is currently being studied in clinical trials for its effectiveness in treating geographic atrophy secondary to age-related macular degeneration. The main therapeutic indication is to improve visual function and visual acuity in affected patients. ANX007 works by targeting specific molecular pathways involved in the progression of macular degeneration, aiming to slow down or halt the deterioration of vision. It is classified pharmacologically as a treatment for eye disorders, specifically those related to macular degeneration.

Investigated diseases

Geographic Atrophy Secondary to Age-Related Macular Degeneration – This condition is a progressive eye disease that affects the macula, the central part of the retina responsible for sharp vision. It is a form of age-related macular degeneration (AMD) characterized by the gradual loss of retinal cells, leading to areas of atrophy or thinning. As the disease progresses, these atrophic areas expand, causing a decline in central vision. Patients may experience difficulty with tasks that require detailed vision, such as reading or recognizing faces. The progression of geographic atrophy can vary, with some individuals experiencing a slow decline in vision over several years.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515022-88-00Protocol codeANX007-GA-02Estimated enrolment630 patientsSponsorAnnexon Inc.

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On this site, “treatment” means an investigational medicine being studied in a clinical trial. Its safety and efficacy for the use being studied have not yet been confirmed, some participants may receive a placebo or a comparator medicine, and taking part does not guarantee any health benefit. The decision to take part is made by the doctor at the research site. This site is for information only and does not replace medical advice.

This service is not affiliated with the European Commission, the EMA, or the official CTIS system. Most information comes from publicly available international clinical-trial registries, supplemented by data from academic sites, national regulators and commercial sponsors. On this site, “treatment” and “therapy” mean a medicine being tested in a clinical trial. Its safety and effectiveness in the use being studied are not yet confirmed, some participants may receive a placebo or a comparator, and taking part does not guarantee a health benefit. The doctor at the research site decides who can take part. This site provides information, not medical advice. Certain content and visual elements on this website have been generated or enhanced using artificial intelligence (AI).