AuthorisedTherapeutic exploratory (Phase II)Interventional

A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of RGX-314 Following Subretinal Administration in Participants with Neovascular Age-related Macular Degeneration and Fellow Eye Treatment Substudy

This research is a long-term look at a new treatment called Surabgene Lomparvovec (ABBV-RGX-314) for people with wet age-related macular degeneration (nAMD). This type of AMD can cause vision loss. The treatment is given as a one-time injection under the retina, the light-sensing part at the back of your eye. Researchers want to see how safe this treatment is over several years and how well it helps control the condition. They are particularly interested in whether it can reduce the number of other eye injections people might need and help maintain their vision. This study is an important step in understanding new ways to treat nAMD.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

AbbVie Deutschland GmbH & Co. KG

Enrolment target

Start

14 Jul 2025

Neovascular age-related macular degeneration

What is this study about?

This study is a long-term follow-up to see how a new treatment, Surabgene Lomparvovec (we'll call it ABBV-RGX-314 for short), works for people with a common eye condition called wet age-related macular degeneration, or nAMD. This condition affects the central part of your vision and can make everyday tasks like reading or recognising faces difficult.

ABBV-RGX-314 is a special type of treatment that gets delivered directly to the eye in a single procedure. The main purpose of this follow-up study is to check on the safety of this treatment over several years – meaning how often side effects or problems happen. Researchers will also be looking closely at how effective it is in managing the nAMD.

They want to know if this treatment can help slow down the disease, improve or keep vision stable, and potentially reduce the need for other treatments that people with nAMD often need, such as frequent eye injections. By understanding these long-term effects, doctors hope to find better and more convenient ways to help people living with nAMD.

Key takeaways

This study is about long-term follow-up for a new wet AMD treatment.
It aims to check the safety and how well it works over several years.
Researchers will monitor vision, eye health, and the need for other treatments.
Participation is for people who have already had the ABBV-RGX-314 treatment.
It helps understand if a single treatment can have lasting benefits.
The study assesses how many additional eye injections are needed over time.

Who may be eligible?

To be part of this study, you must be 18 years old or older. There is no upper age limit, meaning both younger and older adults can take part.

This study is for people who have already received the ABBV-RGX-314 treatment in a previous study focusing on wet age-related macular degeneration (nAMD). Essentially, it's a follow-up for people who have already started this specific treatment.

Both men and women are welcome to participate, as gender does not affect whether you can join this particular research.

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 18 years old or older?
Have you previously received the ABBV-RGX-314 treatment for wet AMD?
Are you willing to attend regular monitoring appointments for several years?
Do you have wet age-related macular degeneration (nAMD)?

Answer every question to see your result.

What does participation involve?

If you take part in this study, you will be followed up over several years to monitor your eye health. This will involve regular visits to an eye specialist, where they will check your vision and take detailed pictures of your eye. They will be looking for any changes in your condition or any side effects from the treatment you received previously.

Researchers will also be keeping track of how many additional eye injections you might need to control your nAMD, and how often you visit your eye doctor. You won't receive a new treatment dose in this follow-up study, but your existing treatment effects will be carefully monitored. The total duration of your participation will be several years, as it's a long-term study.

Potential risks and benefits

Participating in this study allows researchers to gather important long-term information about a new treatment for nAMD, which could benefit others in the future. The potential benefits for you personally include continued close monitoring of your eye condition by specialists. As this is a long-term follow-up study, the main risk involves ongoing observation for any side effects from the treatment you previously received, which will be carefully recorded. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (5)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Italy
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Unverified
Hungary
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Unverified
France
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Unverified
Spain
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Unverified
Germany

Common questions

What is the main goal of this study?

The main goal is to see how safe and effective the ABBV-RGX-314 treatment is for wet AMD over a long period, especially in reducing the need for more injections.

Will I receive new treatment in this study?

No, this study is a long-term follow-up for those who have already received the ABBV-RGX-314 treatment in a previous study.

How long will I be followed in this study?

This is a long-term study, so you will be monitored for several years to see the sustained effects of the treatment.

What kind of appointments will I have?

You'll have regular visits with an eye specialist for vision checks, eye scans, and to discuss your eye health and any additional treatments you've received.

Can anyone join this study?

No, this study is specifically for adults aged 18 and over who have already received the ABBV-RGX-314 treatment as part of an earlier trial for wet AMD.