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Long-Term Safety Study of GT005 for Patients with Geographic Atrophy Due to Age-Related Macular Degeneration Previously Treated in a Gyroscope Study

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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 long-term safety of a treatment called GT005 for people with a specific eye condition known as geographic atrophy, which is a form of age-related macular degeneration. This condition affects the central part of the retina, leading to vision loss. Participants in this study have already received GT005 in previous studies conducted by Gyroscope Therapeutics Ltd.

The purpose of this study is to monitor the safety of GT005 over an extended period. The treatment involves a special type of injection called a suspension for injection, which is administered under the retina. This study will observe participants for up to five years to check for any side effects or health issues that might arise from the treatment.

Participants in this study have previously been treated with GT005 in earlier studies named FOCUS, EXPLORE, and HORIZON. The study will focus on identifying any adverse events, which are unexpected health problems that might occur during the study period. This long-term follow-up is essential to ensure the continued safety of the treatment for those with geographic atrophy due to age-related macular degeneration.

The research process

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

Step 1
Joining the study
Participation begins after providing written informed consent, confirming understanding and agreement to the study's terms.
Eligibility requires previous treatment with GT005 in a prior study, specifically GT005-01 (FOCUS), GT005-02 (EXPLORE), or GT005-03 (HORIZON).
Step 2
Initial assessment
An initial assessment is conducted to establish a baseline for monitoring the long-term safety of GT005.
This includes evaluating the current state of geographic atrophy related to age-related macular degeneration.
Step 3
Treatment administration
GT005 is administered as a suspension for injection through subretinal use, which involves delivering the medication directly under the retina.
This step is only applicable if additional administration is required as per the study protocol.
Step 4
Regular follow-up visits
Regular follow-up visits are scheduled to monitor the safety of GT005 over a period of up to 5 years.
These visits focus on identifying any ocular or systemic adverse events, assessing their incidence and severity.
Step 5
Final assessment
A final assessment is conducted at the end of the study period to evaluate the long-term safety outcomes of GT005 treatment.
This includes a comprehensive review of any adverse events experienced during the study.

Who can join the trial?

5 criteria

Must be able and willing to give written informed consent. This means you agree to participate in the study after understanding what it involves.
Must have received **GT005** in a previous study. This refers to a specific treatment you had in one of the earlier studies named FOCUS, EXPLORE, or HORIZON.
Must be willing to attend study visits and complete the study assessments. This means you agree to come to all the appointments and take part in the tests and evaluations required by the study.
Both men and women can participate.
Participants should not be from a vulnerable population. This means the study is not intended for individuals who might need special protection or care.

Who cannot join the trial?

3 criteria

Participants who have not been treated with GT005 in previous studies (GT005-01, GT005-02, or GT005-03) cannot join the study.
Participants with medical conditions other than geographic atrophy (a type of eye disease) caused by age-related macular degeneration (a common eye condition that affects vision) are not eligible.
Participants who are part of a vulnerable population, meaning they might need special protection or care, are not allowed to participate.

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Verified sites

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Centre Hospitalier Universitaire De Dijon
Dijon, France
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Centre Hospitalier Universitaire De Nantes
Nantes, France
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Hospital Universitario De Navarra
Pamplona, Spain

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Investigated drugs

GT005 is a medication being studied for its long-term safety in people with geographic atrophy, a condition related to age-related macular degeneration. The trial aims to monitor any potential side effects or adverse events that may occur up to five years after treatment with GT005. This medication is part of a follow-up study to ensure its safety for patients who have already received it in a previous study.

Gt005

What is already known about the treatment

GT005 – GT005 is administered through an injection directly into the eye, specifically targeting the area affected by geographic atrophy secondary to age-related macular degeneration. Currently, GT005 is under investigation in clinical trials, with a focus on evaluating its long-term safety in participants who have previously received the treatment in earlier studies. The main therapeutic indication for GT005 is to address geographic atrophy, a condition that leads to vision loss in individuals with age-related macular degeneration. At the molecular level, GT005 works by modulating the complement system, which is part of the immune response, to reduce inflammation and slow the progression of retinal damage. It is classified pharmacologically as a gene therapy product, aiming to provide a sustained therapeutic effect through genetic modification.

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 where the cells in the macula gradually break down, leading to a loss of central vision. Over time, this degeneration creates areas of atrophy, or thinning, in the retina, which can expand and merge, worsening vision loss. The progression is typically slow, and while peripheral vision remains intact, tasks requiring detailed vision, such as reading or recognizing faces, become challenging. The condition is more common in older adults and is a leading cause of vision impairment in this age group.