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 study about?

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.

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).

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.

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.

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.

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 Study?

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 Study?

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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Hospital Universitario De Navarra	Pamplona	Spain

Other Sites

Site Name	City	Country
Clinica Baviera S.A.	Madrid	Spain
Universitaetsklinikum Tuebingen AöR	Tuebingen	Germany
Centre Hospitalier Universitaire De Nantes	Nantes	France
Universitaetsklinikum Schleswig-Holstein AöR	Kiel	Germany
Oftalmika Sp. z o.o.	Bydgoszcz	Poland
Cxkcmz Hggckpcaxsf Uitrwrqnadjzh Dj Dvpay	Dijon	France
Ioqplhnny Dn Mlxvidkixlue Ogrkdo Dam Spel	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
France	Not recruiting	05.07.2022
Germany	Not recruiting	05.07.2022
Poland	Not recruiting	05.07.2022
Spain	Not recruiting	05.07.2022

Trial locations

Investigated drugs:

Gt005

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.

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.

Trial ID:

2024-510946-15-00

Protocol code:

CPPY988A12203B

Trial Phase:

Human Pharmacology (Phase I) – Other

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