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Study on the Safety of Avacincaptad Pegol for Patients with Geographic Atrophy Who Completed a Previous Study

Verified siteRegistered drugNo placebo
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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 the safety of a treatment for a condition called geographic atrophy, which is a progressive eye disease that affects the retina and can lead to vision loss. The treatment being studied is called avacincaptad pegol, also known by its code name ARC1905. This medication is administered as a solution for injection directly into the eye, a method known as intravitreal use. The purpose of the study is to assess the long-term safety of this treatment in patients who have already participated in a previous study called ISEE2008 (GATHER2).

During the course of the study, participants will receive monthly injections of avacincaptad pegol for a period of up to 17 months. Some participants may receive a placebo instead. The study will monitor participants for any adverse effects, which are unwanted or harmful reactions to the treatment. Additionally, the study will evaluate the body's immune response to the medication, known as immunogenicity, and how the drug is processed in the body, referred to as pharmacokinetics.

This study is an open-label extension, meaning that both the researchers and participants know which treatment is being administered. It is designed for patients who have completed the previous study and aims to provide further insights into the safety of avacincaptad pegol for treating geographic atrophy. The study is expected to conclude in April 2025.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Consent and eligibility confirmation

    Upon joining the study, you will be asked to provide new written informed consent. This is a document that confirms your willingness to participate in the trial after understanding all the details.

    Your eligibility will be confirmed based on your previous completion of the Study ISEE2008 (GATHER2) and your diagnosis of geographic atrophy.

  2. Step 2

    Initial assessment

    An initial assessment will be conducted to gather baseline information about your health and condition. This may include various tests and evaluations to ensure the trial's safety and effectiveness.

  3. Step 3

    Treatment administration

    You will receive avacincaptad pegol through an injection into the eye, known as an intravitreal injection. This is a solution specifically designed for this type of administration.

    The treatment will be administered once a month for the duration of the trial.

  4. Step 4

    Regular follow-up visits

    You will be required to attend regular follow-up visits throughout the 18-month trial period. These visits are crucial for monitoring your health and the effects of the treatment.

    During these visits, assessments will be conducted to check for any adverse effects and to evaluate the treatment's impact on your condition.

  5. Step 5

    Final assessment

    At the end of the trial, a final assessment will be conducted. This will involve a comprehensive evaluation of your health and the overall outcomes of the treatment.

    The results will help determine the long-term safety and effectiveness of the treatment.

Who can join the trial?

5 criteria

  • Patients must be 50 years or older.
  • Patients must have been diagnosed with geographic atrophy (GA), which is a condition affecting the eye.
  • Patients must have completed the previous study called ISEE2008 (GATHER2) through the Month 24 visit, whether they received the study treatment or a placebo (a harmless substance with no therapeutic effect).
  • Patients must provide new written informed consent to participate in this trial. This means they agree to join the study after being informed about its details.
  • Patients must be able to attend all trial visits for the entire 18-month duration of the study.

Who cannot join the trial?

2 criteria

  • Patients who have not completed the previous study called ISEE2008 (GATHER2) up to the 24-month visit cannot participate.
  • Patients who have not been treated with either **avacincaptad pegol** or a **Sham** (a placebo treatment) in the previous study cannot participate.
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Investigated drugs

Avacincaptad Pegol is a medication used in this clinical trial to help patients with a condition called geographic atrophy, which affects the eyes. This medication works by blocking a part of the immune system known as Complement C5. By doing this, it aims to slow down the damage to the eye that happens in geographic atrophy. In this trial, the medication is given as an injection directly into the eye, which is known as intravitreal administration. The goal is to see if using this medication over a long period is safe for patients who have already participated in a previous study.

What is already known about the treatment

Avacincaptad Pegol – Avacincaptad Pegol is administered through an injection directly into the eye, a method known as intravitreal administration. It is currently being studied in clinical trials to evaluate its long-term safety for patients with a condition called geographic atrophy, which affects the retina and can lead to vision loss. The medication works by inhibiting a part of the immune system called complement C5, which is thought to play a role in the progression of this eye disease. Avacincaptad Pegol is classified as a complement inhibitor, a type of drug that targets specific proteins in the immune system to prevent damage to the body's own tissues.

Investigated diseases

Geographic Atrophy – Geographic atrophy is a progressive eye disease that affects the macula, the central part of the retina responsible for sharp vision. It is characterized by the gradual degeneration of retinal cells, leading to the formation of atrophic lesions. As the disease progresses, these lesions expand, causing a gradual loss of central vision. Peripheral vision typically remains intact, but the ability to see fine details and perform tasks like reading or recognizing faces becomes increasingly difficult. The progression of geographic atrophy can vary among individuals, with some experiencing a slow decline in vision while others may notice more rapid changes. The condition is often associated with age-related macular degeneration, a common cause of vision loss in older adults.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2024-515185-13-00Protocol codeISEE2009Estimated enrolment280 patientsSponsorAstellas Pharma Global Development Inc.

sourced from the EU Clinical Trials Register and site verification

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