AN OPEN-LABEL EXTENSION (OLE) PHASE 3 TRIAL TO ASSESS THE SAFETY OF INTRAVITREAL ADMINISTRATION OF AVACINCAPTAD PEGOL (COMPLEMENT C5 INHIBITOR) IN PATIENTS WITH GEOGRAPHIC ATROPHY WHO PREVIOUSLY COMPLETED PHASE 3 STUDY ISEE2008 (GATHER2)
This study is an extension of a previous trial, meaning it's continuing to gather information from people who have already received a study medicine. It focuses on the long-term safety of a drug called Avacincaptad pegol, which is being investigated for a serious eye condition known as geographic atrophy. This condition causes central vision loss. The study will continue to give the medicine directly into the eye and observe participants carefully to see if there are any side effects over a longer period. It's a Phase 3 study, which means it's one of the final stages before a medicine might be approved for wider use.
At a glance
What is this study about?
This clinical trial is designed to check the long-term safety of a new medicine called Avacincaptad pegol. This medicine is being developed to treat a challenging eye condition called geographic atrophy. Geographic atrophy is a severe form of age-related macular degeneration that leads to central vision loss, making everyday tasks like reading or recognising faces very difficult.
Participants in this study have already taken part in a previous trial (called GATHER2) where they received Avacincaptad pegol. Now, doctors want to see how the medicine affects people over an even longer time. They will be carefully looking for any side effects or problems that might show up with continued use. Since this medicine is given directly into the eye, ensuring its long-term safety is very important.
The main goal of this study is to closely monitor any side effects that might occur. The researchers will also look at how the body reacts to the drug over time and if the body develops any immune responses to it. This information is crucial for understanding whether Avacincaptad pegol could be a safe and helpful treatment for geographic atrophy in the future.
Key takeaways
- This study evaluates the long-term safety of Avacincaptad pegol for geographic atrophy.
- It's an extension for patients who completed a previous trial (GATHER2).
- The medicine is given via eye injections.
- Researchers are carefully tracking side effects and body reactions.
- Participation will involve regular clinic visits and eye assessments.
Who may be eligible?
To be part of this study, you must have previously participated in a specific earlier study, called ISEE2008 (GATHER2), which also investigated the medicine Avacincaptad pegol for geographic atrophy. This means you would have already received this study medicine.
Generally, participants must be adults, aged 18 years or older. Both men and women are welcome to take part in this research. The most important requirement is that you have completed the previous GATHER2 study.
- Are you 18 years old or older?
- Did you previously take part in the GATHER2 study?
- Did you complete your participation in the GATHER2 study?
- Do you have geographic atrophy?
This is a guide only — the research team will confirm whether you can take part.
What does participation involve?
If you join this study, you will continue to receive the study medicine, Avacincaptad pegol, which is given as an injection directly into your eye. You will have regular visits to the clinic, where doctors will check your eyes and overall health very carefully. They will be looking for any potential side effects or changes. Some visits might involve tests to see how your body reacts to the medicine or to watch your eye condition. The total length of your participation will depend on the study plan, but because it's an extension of a previous trial, it will involve ongoing follow-up for a significant period.
Potential risks and benefits
Locations (10)
- —Hungary
- —Belgium
- —France
- —Austria
- —Latvia
- —Italy
- —Spain
- —Czechia
- —Germany
- —Croatia
Common questions
What is geographic atrophy?
It's an advanced form of age-related macular degeneration that causes blind spots in your central vision, making it hard to see fine details.
What is Avacincaptad pegol?
It's a study medicine being tested for its ability to slow down the progression of geographic atrophy.
Why is this study only for people from a previous trial?
This study is an extension to find out if the medicine is safe when used for a longer time after the initial study period.
What does 'intravitreal administration' mean?
It means the medicine is given directly into your eye using a very fine needle.
What does a 'Phase 3' study mean?
It means this is one of the final stages of testing before a new medicine might be considered for wider use.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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