A Phase 3, Open-Label, Multicenter, Extension Study to Evaluate the Long-Term Safety and Efficacy of Pegcetacoplan in Subjects with Geographic Atrophy Secondary to Age-Related Macular Degeneration
This research study is for people who have Geographic Atrophy, a common eye condition that can lead to vision loss. It's an extension of previous studies, meaning participants will continue to receive a treatment called pegcetacoplan (also known as APL-2) for a longer period. The main goal is to find out more about the long-term safety of this treatment and if it helps people keep their vision or slows down the progression of the condition. Researchers will closely monitor for any side effects, both in the eyes and elsewhere in the body. They will also measure how much the affected area of the eye changes over time and how well people can see and read.
At a glance
What is this study about?
This study is designed for individuals who have already participated in an earlier study looking into a treatment called pegcetacoplan (or APL-2) for Geographic Atrophy. Geographic Atrophy is a condition that affects part of the eye called the macula, which is responsible for sharp, central vision. It's often linked to age-related macular degeneration (AMD) and can cause blind spots and difficulties with reading or recognising faces.
The main purpose of this study is to gather more information about how safe pegcetacoplan is when used over a longer period. Researchers also want to see if the treatment helps to slow down the growth of the affected areas in the eye and if it improves or maintains people's vision. By continuing to follow participants, they can understand the long-term benefits and any potential downsides.
This is a 'Phase 3' study, which means the treatment has already shown some promise in earlier, smaller studies and is now being tested on a larger group of people to confirm its effects. The results from this type of study are very important to help determine if the treatment could eventually become widely available.
Key takeaways
- This study is for long-term safety and effectiveness of pegcetacoplan for Geographic Atrophy.
- It's an extension study, meaning it's for people already in a related trial.
- Researchers will monitor eye changes, vision, and overall health.
- The treatment aims to slow down the progression of the eye condition.
- Both men and women aged 18 and over can participate if they meet the previous study criteria.
Who may be eligible?
To be considered for this study, you must have previously taken part in an earlier study looking at the treatment pegcetacoplan for Geographic Atrophy. This means it's not a study for people newly diagnosed with the condition, but for those who have already started the treatment in a research setting.
Participants must be at least 18 years old. There is no upper age limit, meaning older adults are welcome to participate. Both men and women can join this study.
Overall, the most important requirement is your previous involvement in a related study for Geographic Atrophy where you received pegcetacoplan.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- I have Geographic Atrophy secondary to Age-Related Macular Degeneration.
- I have previously participated in a study using pegcetacoplan for this condition.
- I am 18 years old or older.
- I am willing and able to attend regular clinic visits.
What does participation involve?
If you join this study, you will continue to receive the pegcetacoplan treatment. You will have regular visits to the clinic where the study team will carry out various checks. These visits will involve detailed eye examinations, including special scans to measure the affected area of your eye. Your vision will be tested in different ways, such as reading charts and looking at detailed images. The team will also monitor your general health to check for any side effects from the treatment, both in your eyes and in your body. The study will last for a period of time that allows researchers to observe the long-term effects of the treatment.
Potential risks and benefits
Locations (7)
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Common questions
What is Geographic Atrophy?
It's an eye condition, often linked to age-related macular degeneration (AMD), where parts of your central vision can slowly become damaged, making it harder to see details.
What is pegcetacoplan (APL-2)?
It's a treatment being studied to see if it can help slow down the progression of Geographic Atrophy.
Why is this study important?
This study helps us understand the long-term safety and effectiveness of pegcetacoplan, which could potentially become a new treatment option for this condition.
Who can join this study?
Only people who have already participated in a previous study using pegcetacoplan for Geographic Atrophy are eligible.
Will I get paid to join?
The information provided does not mention payment for participation; you would need to ask the study team directly.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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