Surabgene Lomparvovec for Macular Degeneration

Recruiting at 7 trial locations

Overseen By ABBVIE CALL CENTER

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: AbbVie

Must be taking: Anti-VEGF injections

Disqualifiers: CNV, Macular edema, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 5 years

561 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new gene therapy treatment called Surabgene Lomparvovec (also known as ABBV-RGX-314) for individuals with neovascular age-related macular degeneration (nAMD), a condition where abnormal blood vessels grow in the eye, affecting vision. The trial aims to determine the safety and effectiveness of this treatment compared to the existing treatment, Ranibizumab. Participants will be divided into three groups: two groups will receive different doses of the new gene therapy, and one group will receive the standard treatment. The trial seeks individuals who have previously received treatment for nAMD but continue to experience vision issues. Participants must attend regular monthly visits over several years for check-ups and assessments. As a Phase 3 trial, this treatment is in the final step before FDA approval, offering participants a chance to contribute to a potentially groundbreaking therapy.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Surabgene Lomparvovec (ABBV-RGX-314) was well tolerated in earlier studies. In one study, 60 people received the treatment, and no serious side effects were linked to it. After one year, their vision remained stable or improved. This suggests the treatment is generally safe for individuals with neovascular age-related macular degeneration (nAMD), also known as "wet" AMD. However, it is important to note that this treatment is still under investigation and has not yet received approval from any regulatory authority. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for macular degeneration, which typically involve frequent injections like Ranibizumab, Surabgene Lomparvovec introduces a gene therapy approach. This experimental treatment is administered as a one-time subretinal delivery, potentially reducing the need for ongoing injections. Researchers are excited because Surabgene Lomparvovec targets the underlying genetic causes of the disease rather than just managing symptoms, offering hope for a more lasting solution.

What evidence suggests that this trial's treatments could be effective for neovascular age-related macular degeneration?

Research has shown that Surabgene Lomparvovec (ABBV-RGX-314), one of the treatments in this trial, may help treat neovascular age-related macular degeneration (nAMD), a condition affecting vision. In a study with 60 participants, those who received this gene therapy had stable or improved vision after one year. Importantly, no serious side effects were linked to the drug, indicating it is generally safe. This treatment delivers genetic material to the retina, the light-sensing part of the eye, potentially reducing the need for frequent eye injections. Early results suggest it could help maintain or improve vision over time. Participants in this trial will receive either Surabgene Lomparvovec at different doses or Ranibizumab as a control treatment. ^{1 5 6 7 8}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

This trial is for adults over 50 with 'wet' macular degeneration who've had cataract surgery at least 12 weeks ago and have been treated with specific eye injections in the past 6 months. They should have a certain type of lesion in their eye but can't join if they don't meet these conditions.

Inclusion Criteria

I had cataract surgery in my study eye over 12 weeks ago.

I have been diagnosed with CNV due to AMD in one eye.

My CNV lesion is smaller than 10-disc areas.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a single subretinal dose of ABBV-RGX-314 or Ranibizumab as needed

5 years

Regular monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ranibizumab
• Surabgene Lomparvovec (ABBV-RGX-314)

Trial Overview The study tests Surabgene Lomparvovec, a gene therapy, against Ranibizumab (a control) for 'wet' AMD. Participants are randomly placed into three groups: two receive one dose of ABBV-RGX-314; the third gets regular Ranibizumab injections. The effects will be monitored up to five years.

How Is the Trial Designed?

Group I: Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 Experimental Treatment 1 Intervention

Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 administered via subretinal delivery one time.

Group II: Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 Experimental Treatment 1 Intervention

Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 administered via subretinal delivery one time.

Group III: Ranibizumab Control Group Experimental Treatment 1 Intervention

Ranibizumab administered via intravitreal injection as needed PRN

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Citations

1. regenxbio.com regenxbio.com/getattachment/1411ee65-162f-45af-8958-4770c77ae3a7/Abbey_Sura-vec_SR-FE_CTS-2025_FINAL_.pdf?lang=en-US&ext=.pdf

Subretinal Delivery of Investigational ABBV-RGX-314 as a ... Data cut for first eye: September 11, 2024; second eye: May 26, 2025. This slide presents results from an individual participant and is not ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04704921

NCT04704921 | Pivotal 1 Study of ABBV-RGX-314 (Also ... Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time. Detailed Description. This ...

3. regenxbio.gcs-web.com regenxbio.gcs-web.com/news-releases/news-release-details/regenxbio-announces-completion-enrollment-pivotal-trials

REGENXBIO Announces Completion of Enrollment in Pivotal ... At one year, sura-vec was well tolerated in 60 treated participants with no drug-related serious adverse events, stable to improved vision and ...

4. ophthalmologytimes.com ophthalmologytimes.com/view/regenxbio-completes-enrollment-in-atmosphere-and-ascent-trials-of-sura-vec-in-wet-amd

REGENXBIO completes enrollment in ATMOSPHERE and ... REGENXBIO announces completion of enrollment in pivotal trials of subretinal surabgene lomparvovec for Wet AMD. Published October 6, 2025.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT07007065

NCT07007065 | Study to Assess the Injection Burden, ... Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD) ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT04704921

NCT04704921 | Pivotal 1 Study of ABBV-RGX-314 (Also ... This randomized, partially masked, active-controlled, Phase 2b/3 clinical study will evaluate the efficacy and safety of ABBV-RGX-314 gene therapy in ...

7. news.abbvie.com news.abbvie.com/2025-01-13-AbbVie-and-REGENXBIO-Announce-Updates-on-the-ABBV-RGX-314-Clinical-Program

AbbVie and REGENXBIO Announce Updates on the ABBV ... Pivotal data evaluating the safety and efficacy of the subretinal delivery of ABBV-RGX-314 in patients with wet age-related macular degeneration ...

8. ir.regenxbio.com ir.regenxbio.com/news-releases/news-release-details/regenxbio-announces-pivotal-program-surabgene-lomparvovec

REGENXBIO Announces Pivotal Program for Surabgene ... New Phase II ALTITUDE® trial data demonstrate a durable safety and efficacy profile observed through two years with a single, in-office ...