Study to Assess the Injection Burden, Adverse Events, Change in Disease Activity, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec in Adult Participants With Neovascular Age-Related Macular Degeneration (nAMD)
This study is investigating a new treatment called Surabgene Lomparvovec for a common eye condition called 'wet' age-related macular degeneration (nAMD). This condition causes new, abnormal blood vessels to grow at the back of the eye, which can affect your vision. The study wants to find out how safe and effective this new gene therapy is for treating nAMD. It also aims to see if it can reduce the number of injections people need and help preserve their eyesight over time. Participants will be adults aged 50 and over who have been previously treated for their nAMD. They will be split into different groups, receiving either the new gene therapy or standard injections. The study will last up to 5 years.
At a glance
What is this study about?
This research study is focused on a eye condition called 'wet' age-related macular degeneration (nAMD). This is a common and serious eye disease that can lead to blurred vision or even blindness if not treated. It happens when abnormal new blood vessels grow under the central part of your retina (the light-sensitive layer at the back of your eye), which can leak fluid and blood, damaging your vision.
The main goal of this study is to test a new treatment called Surabgene Lomparvovec. This is a type of gene therapy, which is a cutting-edge approach that aims to change how your body works at a very basic level to fight the disease. The researchers want to know if this new treatment is safe to use and how well it works compared to the standard treatments currently available. They are particularly interested in whether it can reduce how often people need eye injections and help keep their vision stable in the long run.
Ultimately, the hope is that this new gene therapy could offer a more convenient and effective way to manage 'wet' AMD, potentially reducing the burden of frequent hospital visits and injections that many people with the condition currently face. By helping to preserve vision, it could significantly improve the quality of life for those affected by this eye disease.
Key takeaways
- This study is testing a new gene therapy for 'wet' AMD.
- It aims to reduce injection burden and preserve vision.
- Participants will be aged 50+ with previously treated 'wet' AMD.
- The study involves either a single gene therapy injection or ongoing standard injections.
- You will have monthly visits for up to 5 years.
- It's a global study involving over 500 participants.
Who may be eligible?
To join this study, you need to be an adult aged 50 or over and have received treatment for 'wet' age-related macular degeneration (nAMD) before. You also need to have had cataract surgery in the eye being studied at least 12 weeks before beginning the trial.
There are also specific details about your eye condition that need to be met. For example, your 'wet' AMD should not be too widespread, and you must have already had at least two regular eye injections for your condition in the last six months, and these treatments must have been effective for you.
However, you wouldn't be able to join if your 'wet' AMD was diagnosed more than four years ago in the eye being studied, or if your vision problems are due to other eye conditions. Also, if there are certain other features or issues on the scans of your eye, like a lot of bleeding or specific types of detachments, you might not be suitable for this study.
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 50 years old or older?
- Do you have 'wet' age-related macular degeneration (nAMD) in one eye?
- Have you had cataract surgery in that eye at least 12 weeks ago?
- Have you received at least 2 regular eye injections for your nAMD in the last 6 months?
- Has your doctor confirmed those previous treatments were effective for you?
- Has your 'wet' AMD been diagnosed within the last 4 years in the study eye?
What does participation involve?
If you decide to take part in this study, you will be assigned to one of three different groups. Two groups will receive the new gene therapy, Surabgene Lomparvovec, as a one-time injection into the back of your eye, under the retina. The third group will receive regular injections of a standard treatment called Ranibizumab into the jelly-like substance in your eye, as and when needed. The initial treatment choices are decided randomly, like flipping a coin.
The study will last for up to 5 years. During this time, you will need to attend regular monthly visits at a hospital or clinic. These visits will involve various medical checks, including eye examinations, blood tests, and looking for any side effects. You will also be asked to fill out questionnaires about how you are feeling and your vision. It's important to be aware that taking part in a study like this might involve more hospital visits and assessments than your usual routine care.
Potential risks and benefits
Locations (128)
- Barnet Dulaney Perkins Eye Centers /ID# 279265Verified postcodeMesa, United States· Recruiting
- American Vision Partners /ID# 264615Verified postcodeSun City, United States· Recruiting
- Retinal Diagnostic Center /ID# 263054Verified postcodeCampbell, United States· Recruiting
- The Retina Partners /ID# 263265Verified postcodeEncino, United States· Recruiting
- Retina Associates of Southern California /ID# 263056Verified postcodeHuntington Beach, United States· Recruiting
- Northern California Retina Vitreous Associates - Mountain View /ID# 263990Verified postcodeMountain View, United States· Recruiting
- Retina Consultants of San Diego /ID# 264026Verified postcodePoway, United States· Recruiting
- Retina Consultants Of Southern California - Redlands /ID# 276496Verified postcodeRedlands, United States· Recruiting
- Kaiser Permanente - Riverside Medical Center /ID# 263253Verified postcodeRiverside, United States· Recruiting
- Retinal Consultants - Sacramento - Greenback Lane /ID# 263983Verified postcodeSacramento, United States· Recruiting
- UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058Verified postcodeSan Francisco, United States· Recruiting
- Orange County Retina Medical Group /ID# 266612Verified postcodeSanta Ana, United States· Recruiting
Common questions
What is 'wet' age-related macular degeneration (nAMD)?
It's an eye condition where new, abnormal blood vessels grow at the back of your eye, which can leak and damage your central vision.
What is Surabgene Lomparvovec?
It's a new gene therapy being tested for 'wet' AMD. It aims to treat the condition by changing how your body works at a basic level.
How will the treatments be given?
The new gene therapy is a single injection under the retina, while the standard treatment (Ranibizumab) is given as regular injections into the jelly of the eye.
How long will the study last?
The study will last for up to 5 years, with regular monthly check-ups during that time.
Can I leave the study at any time?
Yes, your participation is voluntary, and you can withdraw from the study at any point without it affecting your medical care.
How to find out more
ABBVIE CALL CENTER
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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