Safety and Efficacy of ADVM-022 in Treatment-Experienced Patients With Neovascular Age-related Macular Degeneration [LUNA]
The LUNA study is a stage 2 clinical trial investigating a new gene therapy called ADVM-022 for 'wet' Age-related Macular Degeneration (nAMD). This condition affects the central vision and usually requires regular injections into the eye to prevent vision loss. This new gene therapy, ADVM-022, aims to provide long-lasting treatment with just one injection directly into the eye. This could mean fewer trips to the clinic for patients, potentially leading to better outcomes. The study will assess how safe ADVM-022 is and how well it works in people who have previously received treatment for nAMD. We are testing two different doses of the treatment and different ways to manage potential inflammation after the injection. Participants will be followed for about five years.
At a glance
What is this study about?
Wet Age-related Macular Degeneration, often called nAMD, is an eye condition that can cause blurred vision or blind spots. It happens when abnormal blood vessels grow in the back of your eye, leaking fluid and damaging your central vision. Currently, many people with nAMD need frequent injections into their eye, sometimes as often as every month, to stop this damage. While these treatments are effective, the need for regular injections can be a big commitment and sometimes people miss appointments, which can unfortunately lead to vision getting worse.
This study, called LUNA, is looking at a new type of treatment for nAMD called ADVM-022. It's a gene therapy, which means it works by introducing new genetic material into your body to help it fight the disease. The idea is that with just one injection, ADVM-022 could deliver a continuous supply of medicine (similar to that in current eye injections) directly into the eye for a long time. This could mean fewer clinic visits and less burden for patients, while still protecting their vision.
In this study, we want to understand how safe ADVM-022 is, how well it's tolerated by the body, and how effective it is at treating nAMD. We are looking at two different strengths of the ADVM-022 gene therapy, and also trying out different ways to prevent any inflammation that might happen after the injection, using steroid medicines. We hope this research will lead to a simpler and more sustained way to manage nAMD in the future.
Key takeaways
- New gene therapy for 'wet' AMD (ADVM-022) aims for sustained treatment.
- Potential to reduce the need for frequent eye injections.
- Study involves a single injection of the gene therapy.
- Follow-up for about five years to assess safety and effectiveness.
- Two different doses and steroid regimens are being tested.
- Participation is voluntary, and you can withdraw at any time.
Who may be eligible?
To join the LUNA study, you need to be at least 50 years old. You must have 'wet' Age-related Macular Degeneration (nAMD) and have already been receiving regular eye injections for this condition. We would expect you to have shown a good response to your previous treatments, and for you to have received at least two injections in the last four months for your study eye. Your vision in the eye being studied will need to be within a certain range, which the study doctor will check.
There are also some reasons why you might not be able to join. For example, if you have certain other eye conditions or infections, or if you have uncontrolled diabetes or other uncontrolled health problems. If you've had certain eye surgeries in the past, or if you've previously had gene therapy or certain other experimental treatments, you might not be eligible. The study doctor will go through all the criteria with you to make sure it's the right study for you.
Your safety is very important, so the eligibility checks are designed to make sure that the study is suitable for you and that taking part is as safe as possible.
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?
- Have you been diagnosed with 'wet' Age-related Macular Degeneration (nAMD)?
- Are you currently receiving regular eye injections for nAMD and have you responded well to them?
- Have you had at least two eye injections for nAMD in the last four months?
- Do you have good control of any other health conditions, like diabetes?
What does participation involve?
If you decide to take part in the LUNA study, you would receive a single injection of the study gene therapy, ADVM-022, into one of your eyes. You would also receive a course of steroid medicine, either as eye drops or tablets, to help manage any potential inflammation after the injection. The study team will assign you to one of the different doses of ADVM-022 and one of the steroid plans. Throughout the study, you'll have regular check-ups at the clinic, where the study team will monitor your vision and general eye health. These visits will involve various eye tests and examinations. The total participation for this study is approximately five years from the time of your injection, to carefully track the long-term effects of the treatment.
Potential risks and benefits
Locations (39)
- Adverum Clinical Site 178Verified postcodePhoenix, United States
- Adverum Clinical Site 126Verified postcodePhoenix, United States
- Adverum Clinical Site 159Verified postcodeTucson, United States
- Adverum Clinical Site 100Verified postcodeBeverly Hills, United States
- Adverum Clinical Site 172Verified postcodeEncino, United States
- Adverum Clinical Site 169Verified postcodeFullerton, United States
- Adverum Clinical Site 170Verified postcodePasadena, United States
- Adverum Clinical Site 174Verified postcodePoway, United States
- Adverum Clinical Site 164Verified postcodeRiverside, United States
- Adverum Clinical Site 166Verified postcodeSacramento, United States
- Adverum Clinical Site 175Verified postcodeSanta Barbara, United States
- Adverum Clinical Site 116Verified postcodeLakewood, United States
Common questions
What is 'wet' Age-related Macular Degeneration (nAMD)?
It's an eye condition where abnormal blood vessels grow in the back of your eye, leading to blurred central vision or blind spots.
What is gene therapy, and how does ADVM-022 work?
Gene therapy introduces new genetic material to your eye. ADVM-022 aims to help your eye produce its own medicine to treat nAMD for a long time after a single injection.
Will I still need eye injections if I join the study?
The goal of ADVM-022 is to reduce the need for frequent injections. You will receive one injection of ADVM-022, and the study will assess if this successfully reduces further injections.
How long will I be in the study?
If you join, the study will follow your progress for about five years after you receive the single treatment injection.
Can I leave the study if I change my mind?
Yes, your participation is completely voluntary. You can choose to leave the study at any time, and this will not affect your regular medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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