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Long-term Safety and Effectiveness Evaluation of RGX-314 in Patients with Neovascular Age-related Macular Degeneration

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study evaluates the long-term safety and effectiveness of ABBV-RGX-314 in people with neovascular age-related macular degeneration (nAMD). Neovascular age-related macular degeneration is a condition that causes abnormal blood vessel growth under the retina (the light-sensitive tissue at the back of the eye), leading to vision loss. The treatment being evaluated, ABBV-RGX-314, is administered by subretinal (under the retina) injection and is designed to help reduce the need for frequent eye injections typically required to treat this condition.

The purpose of this research is to monitor participants who previously received ABBV-RGX-314 in earlier clinical trials to evaluate its long-term safety and effectiveness. The study includes follow-up assessments of vision using best-corrected visual acuity (BCVA) testing and measurements of central retinal thickness (CRT) using specialized imaging. The study also tracks how many additional anti-VEGF (vascular endothelial growth factor) injections participants might need over time. Anti-VEGF medications help control the growth of abnormal blood vessels in the eye.

Additionally, this study includes a "Fellow Eye Treatment Substudy" which will evaluate treatment in the other eye of participants who have nAMD in both eyes. Participants will be monitored for any side effects and changes in their vision over a period of several years.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Study entry
After completing a previous clinical study of ABBV-RGX-314 for neovascular age-related macular degeneration (nAMD), you will be invited to participate in this long-term follow-up study.
NAMD is a condition where abnormal blood vessels grow under the retina (the light-sensitive tissue at the back of the eye) and can leak fluid, causing vision loss.
The purpose of this study is to evaluate the long-term safety and effectiveness of ABBV-RGX-314 (also called surabgene lomparvovec), which was previously administered to your eye.
Step 2
Follow-up visits
You will attend regular follow-up visits with your retina specialist to monitor your eye condition.
During these visits, the doctor will assess your Best Corrected Visual Acuity (BCVA), which measures how well you can see with the best possible glasses prescription.
The doctor will also measure the Central Retinal Thickness (CRT) using a special imaging technique called Spectral Domain Optical Coherence Tomography (SD-OCT). This is a non-invasive scan that shows detailed images of your retina.
Step 3
Supplemental anti-VEGF injections
Based on your eye condition during follow-up visits, you may receive additional anti-VEGF injections. These are medications that target a protein called Vascular Endothelial Growth Factor that contributes to abnormal blood vessel growth in nAMD.
The study will track how many additional anti-VEGF injections you need over years 2, 3, 4, and 5 of follow-up.
The need for these injections helps determine how well the ABBV-RGX-314 treatment is working long-term.
Step 4
Safety monitoring
Throughout the study, which continues until July 2030, any side effects or health problems will be monitored and recorded.
The study team will track both eye-related problems (ocular adverse events) and other health issues (non-ocular adverse events).
Special attention will be given to specific types of side effects that are of particular interest for this treatment (adverse events of special interest).
Step 5
Fellow Eye Treatment Substudy
Some participants may be eligible for treatment in their other eye (fellow eye) as part of a substudy.
If you participate in this portion, your previously untreated eye may receive ABBV-RGX-314 treatment.
Similar assessments will be conducted for this eye as were done for your originally treated eye.
Step 6
Study completion
The study is scheduled to end by July 2030, with final results available after all data is collected and analyzed.
At the end of the study, you will continue to receive standard care for your eye condition as determined by your eye doctor.

Who can join the trial?

4 criteria

You must have neovascular age-related macular degeneration (a condition where abnormal blood vessels grow under the retina in the back of the eye, causing vision loss)
You must be able and willing to provide written, signed informed consent to participate in this study
You must have previously participated in a clinical study where you received ABBV-RGX-314 administered under the retina for treating neovascular age-related macular degeneration
You must be willing and able to follow all study procedures

Who cannot join the trial?

10 criteria

You are pregnant, planning to become pregnant, or breastfeeding during the study period.
You have a history of eye conditions that could interfere with the study, such as certain types of glaucoma (increased pressure in the eye) or diabetic retinopathy (eye damage due to diabetes).
You have had eye surgery within 30 days before starting the study.
You have an active eye infection or inflammation.
You have uncontrolled high blood pressure.
You have a known allergy to any of the study medications.
You are currently participating in another clinical trial.
You have a significant medical condition that the study doctor thinks might make it unsafe for you to participate.
You have had a stroke or heart attack within the past 6 months.
You have a known immune system disorder that could affect how your body responds to the treatment.

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Verified sites

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ASST Fatebenefratelli Sacco
Milan, Italy
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Azienda Ospedaliera Universitaria Universita' Degli Studi Della Campania Luigi Vanvitelli
Naples, Italy
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Azienda Sanitaria Universitaria Friuli Centrale
Udine, Italy

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Investigated drugs

ABBV-RGX-314 is an investigational gene therapy designed to treat neovascular age-related macular degeneration (also known as wet AMD). This therapy is given through a subretinal injection (an injection under the retina of the eye). It works by delivering a gene that enables eye cells to produce a protein that blocks VEGF, a substance that causes abnormal blood vessel growth and leakage in the eye that leads to vision loss in wet AMD. The goal of this treatment is to potentially reduce the need for frequent anti-VEGF injections that are currently the standard treatment for wet AMD.

What is already known about the treatment

ABBV-RGX-314 – A gene therapy product administered through subretinal injection, designed to treat neovascular age-related macular degeneration (wet AMD). Currently in clinical trials, this therapy aims to reduce the need for frequent anti-VEGF injections by enabling the eye to produce its own anti-VEGF protein. ABBV-RGX-314 works by delivering a gene that instructs retinal cells to produce a protein similar to existing anti-VEGF medications, potentially offering long-term management of wet AMD with a single treatment. It belongs to the class of adeno-associated virus (AAV) vector gene therapies and represents an innovative approach to treating this chronic eye condition.

Investigated diseases

Neovascular age-related macular degeneration is an advanced form of age-related macular degeneration characterized by the abnormal growth of new blood vessels under the retina. These fragile vessels leak blood and fluid into the macula, causing damage to the photoreceptors responsible for central vision. The disease typically begins with distortion of straight lines, followed by a blurry or dark spot in the center of vision that gradually expands. As the disease progresses, patients experience increasing difficulty with daily activities requiring detailed vision such as reading, recognizing faces, and driving. The condition primarily affects older adults, with risk increasing significantly after age 50.