An Optimised GA Interventional Trial (Opti-GAIN) to Test if Treatment With CTx001 is Safe and Works for People With Geographic Atrophy (GA)
The Opti-GAIN study is looking into a new treatment called CTx001 for people who have geographic atrophy (GA), a condition that can lead to vision loss, often linked to age-related macular degeneration (AMD). This study is in its early stages (Phase 1 and 2), meaning we're mainly checking if CTx001 is safe when given as a single injection into the eye. We will also carefully observe if it has any positive effects on vision or the eye condition itself. Participants will be monitored regularly for two years to check its safety and how well it works, and then for longer-term safety for up to five years. This research aims to find better ways to help people living with GA.
At a glance
What is this study about?
Geographic atrophy (GA) is an advanced form of 'dry' age-related macular degeneration (AMD), a common eye condition that can affect your central vision. It happens when cells in certain parts of the retina, the light-sensitive tissue at the back of your eye, waste away. This can cause blurry spots or missing patches in your vision.
This study is testing a new treatment called CTx001. Our main goal is to find out if this treatment is safe for people with GA. We'll also be looking closely to see if it can help improve or slow down the progression of GA. The treatment involves a single injection directly into the eye.
We understand that taking part in a study is a big decision. We want to assure you that your safety is our top priority. We'll be carefully monitoring participants over several years to understand both the immediate and long-term effects of this new treatment. We hope this research will lead to new and better ways to manage GA and help people maintain their precious eyesight.
Key takeaways
- The Opti-GAIN study is testing a new treatment (CTx001) for geographic atrophy (GA).
- It aims to see if the treatment is safe and effective for GA caused by AMD.
- Participation involves a single eye injection and up to five years of follow-up appointments.
- Your safety is a top priority, with close monitoring throughout the study.
- This is an early-stage study, meaning we are still learning about how it works.
Who may be eligible?
To join this study, we're looking for people generally aged 55 or older who have geographic atrophy (GA) in both eyes due to age-related macular degeneration (AMD). Your GA needs to meet certain size requirements, and your vision in the study eye and your other eye will be checked to make sure it fits the study's specific levels. We'll also need you to be able to understand the study and agree to follow all the instructions.
However, some things might mean you can't take part. This includes if your vision problems are from something other than AMD, if you've had certain eye surgeries or laser treatments before, or if you've previously had injections or other treatments in your eye for AMD. You also can't join if you have 'wet' AMD, uncontrolled glaucoma, or other serious eye problems or general health conditions that could make your participation unsafe or difficult.
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.
- Are you generally 55 years old or older?
- Do you have geographic atrophy (GA) in both eyes due to AMD?
- Have you NOT had 'wet' AMD?
- Have you NOT had certain eye surgeries or treatments in the study eye recently?
- Are you able and willing to attend all study appointments and follow instructions?
What does participation involve?
If you decide to take part in this study, you'll receive a single injection of the study medicine, CTx001, into one of your eyes. Following this, you will have regular check-ups at the hospital. These visits will involve various eye tests and examinations to monitor your vision and the health of your eyes, as well as to check for any side effects. These regular checks will happen over two years. After these two years, you'll continue to have annual checks for up to five years to make sure we understand the long-term safety of the treatment. The total duration of your participation in the study, including all follow-up appointments, will be up to five years.
Potential risks and benefits
Locations (5)
- Midwest Eye InstituteVerified postcodeCarmel, United States· Recruiting
- Sierra Eye AssociatesVerified postcodeReno, United States· Recruiting
- Retina Foundation of the SouthwestVerified postcodeDallas, United States· Recruiting
- Gundersen Health SystemVerified postcodeLa Crosse, United States· Recruiting
- The Retina Clinic LondonVerified postcodeLondon, United Kingdom· Recruiting
Common questions
What is geographic atrophy?
It's an advanced form of 'dry' age-related macular degeneration (AMD) where cells in the back of your eye waste away, causing blurry or missing patches in your central vision.
What is CTx001?
CTx001 is the name of the new experimental medicine being tested in this study to see if it's safe and can help with geographic atrophy.
How will the treatment be given?
The treatment will be given as a single injection directly into one of your eyes.
How long will I be in the study?
You'll have regular check-ups for two years after the treatment, and then annual checks for up to five years in total.
Can I leave the study if I change my mind?
Yes, you can choose to leave the study at any time, and it won't affect your regular medical care.
How to find out more
Muhammad Ali Memon
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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