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)

Phase 3

Not yet recruiting

• Conditions: Neovascular Age-related Macular Degeneration
• Interventions: Drug: Surabgene Lomparvovec (ABBV-RGX-314); Drug: Ranibizumab Control

• Registration Number: NCT07007065
• Lead Sponsor: AbbVie

Brief Summary

Neovascular age-related macular degeneration (nAMD), also known as "wet" AMD, is the abnormal growth of new blood vessels in the light-sensitive tissue at the back of the eye called the retina. The purpose of this study is to assess how safe and effective Surabgene Lomparvovec is in treating participants with Neovascular age-related macular degeneration (nAMD).

Surabgene Lomparvovec (ABBV-RGX-314) is an investigational gene therapy being developed for the treatment of neovascular age-related macular degeneration (nAMD). Participants will be placed into 1 of 3 groups, called treatment arms. Each group receives different treatment. Adult participants aged 50 and older years with a diagnosis of previously treated nAMD will be enrolled. Around 561 participants will be enrolled in the study at approximately 150 sites worldwide.

Participants in groups 1 and 2 will receive a single subretinal dose of ABBV-RGX-314. Participants in group 3 will receive Ranibizumab as needed throughout the study. Ranibizumab will be given as an intravitreal injection (injection into the jelly-like tissue that fills the eyeball injection), and ABBV-RGX-314 will be given as a subretinal (between the retina and the back of the eye) injection. The Assessment Period begins after randomization (1:1:1) to one of the ABBV-RGX-314 treatment groups or control at Week -2 and lasts up to 5 years.

There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular monthly visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study First Submitted: 2025-05-28
• Study First Submitted QC: 2025-05-28
• Last Update Submitted: 2025-05-28
• Study First Posted: 2025-06-05
• Last Update Posted: 2025-06-05
• Study Start: 2025-09-17
• Primary Completion: 2033-03
• Study Completion: 2033-03

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 561

Inclusion Criteria

• Pseudophakic (at least 12 weeks post cataract surgery at Screening Visit 1 [Week -6]) in the study eye.

• Must have a diagnosis of choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD) in the study eye

  --CNV lesion characteristics as assessed by the central reading center: lesion size needs to be less than 10-disc areas (typical disc area = 2.54 mm^2)

• Must have received at least 2 intravitreal anti-vascular endothelial growth factor (VEGF) injections in the past 6 months in the study eye prior to Screening Visit 1 (Week -6) and have been responsive (determined by investigator)

Exclusion Criteria

• CNV or macular edema in the study eye that is secondary to any causes other than AMD
• Study eye with nAMD diagnosed > 4 years from Screening Visit 1
• Any retinal pigment epithelial detachment > 400 μm or any pigment epithelial detachment > 350 μm within the central subfield (central 1 mm) in the study eye at Screening Visit 1 (Week -6), as assessed by the central reading center.
• Any subretinal hemorrhage in the study eye > 50% of the total lesion area or within the parafovea (3 mm center of the macula), as determined by the central reading center
• Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Surabgene Lomparvovec (ABBV-RGX-314) Dose 1	Surabgene Lomparvovec (ABBV-RGX-314)	Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 1 administered via subretinal delivery one time.
Surabgene Lomparvovec (ABBV-RGX-314) Dose 2	Surabgene Lomparvovec (ABBV-RGX-314)	Participants will receive Surabgene Lomparvovec (ABBV-RGX-314) Dose 2 administered via subretinal delivery one time.
Ranibizumab Control Group	Ranibizumab Control	Ranibizumab administered via intravitreal injection as needed PRN

Primary Outcome Measures

Name	Time	Method
Annualized intravitreal anti-VEGF injection rate	Up to Week 54	To assess the injection burden and the necessity for supplemental anti-VEGF injections over the first year of the study period across the different treatment groups.
Number of Participants Experiencing Adverse Events	Up to 5 years	An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.

Secondary Outcome Measures

Name	Time	Method
Change from Baseline in best corrected visual acuity (BCVA)	Up to 3 Years	BCVA will be measured using an Early Treatment Diabetic Retinopathy Study (ETDRS) visual acuity chart
Annualized intravitreal anti-VEGF injection rate	Up to 3 Years	To evaluate the long-term injection burden and the necessity for supplemental anti-VEGF injections across the different treatment groups.