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Study on Long-Term Safety and Effects of Pegcetacoplan 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, which is a form of Age-Related Macular Degeneration (AMD). AMD is an eye disease that can lead to vision loss in older adults. The treatment being tested in this study is called Pegcetacoplan, also known by its code name APL-2. Pegcetacoplan is administered as a solution for injection directly into the eye, a method known as intravitreal use.

The purpose of this study is to evaluate the long-term safety and effectiveness of Pegcetacoplan in individuals with Geographic Atrophy due to AMD. Participants in this study will receive regular injections of Pegcetacoplan over a period of time. The study will monitor the safety of the treatment and its impact on the progression of the disease. Participants will undergo various assessments to track changes in their vision and the condition of their eyes.

This study is an extension of previous research, meaning it continues to follow participants who have already been involved in earlier trials of Pegcetacoplan. The goal is to gather more information about how the treatment works over a longer period and to ensure it remains safe for use. Participants will be closely monitored by healthcare professionals throughout the study to ensure their well-being and to collect valuable data on the treatment's effects.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Participation begins after completing a previous study or treatment phase related to geographic atrophy secondary to age-related macular degeneration.
Eligibility is confirmed based on specific criteria, including eye health and, for women, a negative pregnancy test.
Step 2
Initial assessment
An initial assessment is conducted to ensure clarity of ocular media and adequate pupillary dilation.
Good quality images of the eyes are collected for evaluation.
Step 3
Treatment administration
The medication pegcetacoplan is administered as a solution for injection directly into the eye (intravitreal use).
The frequency and duration of administration are determined by the study protocol.
Step 4
Ongoing monitoring
Regular monitoring is conducted to assess the safety and effects of the treatment.
This includes measuring the area and growth rate of geographic atrophy lesions using imaging techniques.
Step 5
Vision assessments
Vision is evaluated using various tests, such as reading speed and visual acuity charts.
Additional assessments may include measuring macular sensitivity and other eye function parameters.
Step 6
Completion of study
The study is expected to conclude by June 2025.
Final assessments are conducted to evaluate the long-term safety and efficacy of the treatment.

Who can join the trial?

6 criteria

The study is for people with a condition called **Geographic Atrophy** due to **Age-Related Macular Degeneration**. This is a specific eye condition.
You must have participated in a previous study called APL2-103 or completed treatment in studies APL2-303 or APL2-304. If you missed the last visit in these studies, you can still join if you are screened within 60 days of the last expected visit.
Your eyes must be clear enough to allow good quality images to be taken, as decided by the study doctor. This applies to the other eye that is not being studied.
If you are a woman, you must either be unable to have children or, if you can have children, you must have a negative pregnancy test before starting and agree to use birth control during the study and for 90 days after the last dose. You must also agree not to breastfeed during the study.
If you are a man with a female partner who can have children, you must agree to use birth control and not donate sperm during the study and for 90 days after the last dose.
You must be willing and able to give informed consent, which means you understand the study and agree to follow the study procedures and assessments.

Who cannot join the trial?

9 criteria

Patients who have any other eye diseases that could affect the study results.
Patients who have had eye surgery within the last three months.
Patients who are currently using other treatments for eye conditions that are not allowed in the study.
Patients with a history of severe allergic reactions to medications.
Patients who have any serious health conditions that could interfere with the study.
Patients who are pregnant or breastfeeding.
Patients who are participating in another clinical trial at the same time.
Patients who have a history of drug or alcohol abuse.
Patients who are unable to follow the study procedures or attend study visits.

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Verified
ASST Fatebenefratelli Sacco
Milan, Italy
Responsive
Fakultni Nemocnice Kralovske Vinohrady
Prague, Czechia
Responsive
Stichting Radboud University Medical Center
Nijmegen, The Netherlands

Trial locations

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Investigated drugs

Pegcetacoplan is a medication being studied for its long-term safety and effectiveness in treating geographic atrophy, which is a condition related to age-related macular degeneration. This medication is administered through an injection into the eye, and the study aims to understand how well it works and how safe it is for patients over an extended period.

Pegcetacoplan

What is already known about the treatment

Pegcetacoplan – Pegcetacoplan is administered through an intravitreal injection, which means it is injected directly into the eye. It is currently being studied in clinical trials for its long-term safety and effectiveness in treating geographic atrophy secondary to age-related macular degeneration. This medication works by inhibiting a part of the immune system known as the complement pathway, which is involved in inflammation and tissue damage. Pegcetacoplan is classified as a complement inhibitor, aiming to slow the progression of vision loss associated with this condition.

Investigated diseases

Geographic Atrophy Secondary to Age-Related Macular Degeneration – This disease is a progressive eye condition that affects the central part of the retina, known as the macula, leading to vision loss. It is a form of age-related macular degeneration where the retinal cells gradually deteriorate, causing patches of atrophy or thinning. Over time, these patches expand, resulting in a gradual decline in central vision, which is crucial for tasks like reading and recognizing faces. The progression of the disease can vary, with some individuals experiencing a slow decline, while others may notice more rapid changes. Peripheral vision usually remains intact, but the loss of central vision can significantly impact daily activities.