Recruiting

Phase 3

Surabgene LomparvovecStudy 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)

Sponsor:

AbbVie

Code:

NCT07007065

Conditions

Neovascular Age-related Macular Degeneration

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

Interventions

Surabgene Lomparvovec (ABBV-RGX-314)

Ranibizumab Control

Study Details

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.

Conditions

Neovascular Age-related Macular Degeneration

Study ID

NCT07007065

Start date

Nov 5, 2025

Status verified date

Sep, 2026

Completion date

Mar, 2033

Anticipated

Primary completion date

Mar, 2033

Anticipated

Eligibility Criteria

Sex: All

Age: 50+

Healthy Volunteers: Not accepted

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

Enrollment

561 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Surabgene Lomparvovec (ABBV-RGX-314) Dose 1

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

experimental: Surabgene Lomparvovec (ABBV-RGX-314) Dose 2

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

experimental: Ranibizumab Control Group

Ranibizumab administered via intravitreal injection as needed PRN

Interventions

Surabgene Lomparvovec (ABBV-RGX-314)

subretinal injection

Ranibizumab Control

intravitreal injection

Primary outcome measure

Annualized intravitreal anti-VEGF injection rate [ Time Frame: Up to Week 54 ]
Number of Participants Experiencing Adverse Events [ Time Frame: Up to 5 years ]

Central Contacts and Locations

Central contacts

ABBVIE CALL CENTER

844-663-3742 abbvieclinicaltrials@abbvie.com

Locations

Barnet Dulaney Perkins Eye Centers /ID# 279265

Recruiting

Mesa, Arizona, United States, 85206

American Vision Partners /ID# 264615

Recruiting

Sun City, Arizona, United States, 85351

Retinal Diagnostic Center /ID# 263054

Recruiting

Campbell, California, United States, 95008

The Retina Partners /ID# 263265

Recruiting

Encino, California, United States, 91436

Retina Associates of Southern California /ID# 263056

Recruiting

Huntington Beach, California, United States, 92647

Shiley Eye Institute At Uc San Diego Health /ID# 276682

Recruiting

La Jolla, California, United States, 92093

Northern California Retina Vitreous Associates - Mountain View /ID# 263990

Recruiting

Mountain View, California, United States, 94040-4119

Eye Research Foundation /ID# 277345

Recruiting

Newport Beach, California, United States, 92663

Retina Consultants of San Diego /ID# 264026

Recruiting

Poway, California, United States, 92064-2530

Retina Consultants Of Southern California - Redlands /ID# 276496

Recruiting

Redlands, California, United States, 92374

Kaiser Permanente - Riverside Medical Center /ID# 263253

Recruiting

Riverside, California, United States, 92505

Retinal Consultants - Sacramento - Greenback Lane /ID# 263983

Recruiting

Sacramento, California, United States, 95841

UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058

Recruiting

San Francisco, California, United States, 94143-2510

Orange County Retina Medical Group /ID# 266612

Recruiting

Santa Ana, California, United States, 92705

Retina Consultants of Southern Colorado /ID# 263284

Recruiting

Colorado Springs, Colorado, United States, 80909

Colorado Retina Associates /ID# 263247

Recruiting

Lakewood, Colorado, United States, 80228

Advanced Vision Surgery Center /ID# 264208

Recruiting

Longmont, Colorado, United States, 80503

Advanced Research, LLC /ID# 276526

Recruiting

Deerfield Beach, Florida, United States, 33064-1346

Segal Drug Trials, Inc /ID# 276966

Recruiting

Delray Beach, Florida, United States, 33484

Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631

Recruiting

Fort Myers, Florida, United States, 33917

Florida Retina Institute - Lake Mary /ID# 263288

Recruiting

Lake Mary, Florida, United States, 32746

Center for Retina and Macular Disease /ID# 264201

Recruiting

Winter Haven, Florida, United States, 33880

Southeast Retina Center /ID# 263264

Recruiting

Augusta, Georgia, United States, 30909

Vision Medical Research /ID# 277102

Recruiting

Oak Lawn, Illinois, United States, 60453

Springfield Clinic Main Campus /ID# 265202

Recruiting

Springfield, Illinois, United States, 62703-2403

Midwest Eye Institute North Indianapolis /ID# 264031

Recruiting

Carmel, Indiana, United States, 46290

Wolfe Eye Clinic - West Des Moines /ID# 263270

Recruiting

West Des Moines, Iowa, United States, 50266

Maine Eye Center - Marginal Way Campus /ID# 263251

Recruiting

Portland, Maine, United States, 04101

The Retina Care Center /ID# 263263

Recruiting

Baltimore, Maryland, United States, 21209

Retina Specialist /ID# 264633

Recruiting

Towson, Maryland, United States, 21204

Associated Retinal Consultants /ID# 263289

Recruiting

Royal Oak, Michigan, United States, 48073

Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427

Recruiting

Edina, Minnesota, United States, 55435

Mayo Clinic - Minnesota /ID# 263977

Recruiting

Rochester, Minnesota, United States, 55905

Retina Institute - St. Louis /ID# 263985

Recruiting

St Louis, Missouri, United States, 63128

Monmouth Retina Consultants /ID# 279252

Recruiting

Little Silver, New Jersey, United States, 07739

Cleveland Clinic - Cleveland /ID# 264210

Recruiting

Cleveland, Ohio, United States, 44195

Ohio State Havener Eye Institute - Columbus /ID# 263987

Recruiting

Columbus, Ohio, United States, 43212

Midwest Retina /ID# 263231

Recruiting

Dublin, Ohio, United States, 43016

Erie Retina Research /ID# 263287

Recruiting

Erie, Pennsylvania, United States, 16507

Mid Atlantic Retina - Philadelphia /ID# 263291

Recruiting

Philadelphia, Pennsylvania, United States, 19107

Charleston Neuroscience Institute - Bluffton /ID# 264037

Recruiting

Bluffton, South Carolina, United States, 29910

Charleston Neuroscience Institute - Charleston /ID# 276425

Recruiting

Charleston, South Carolina, United States, 29414

Retina Consultants of South Carolina - Ladson /ID# 277596

Recruiting

Ladson, South Carolina, United States, 29456

Retina Consultants of America /ID# 264038

Recruiting

Mt. Pleasant, South Carolina, United States, 29464

Retina Research Institute of Texas /ID# 263233

Recruiting

Abilene, Texas, United States, 79606

Austin Retina Associates - Austin /ID# 266770

Recruiting

Austin, Texas, United States, 78705

Austin Clinical Research, LLC /ID# 263229

Recruiting

Austin, Texas, United States, 78750-2298

Star Retina /ID# 266386

Recruiting

Burleson, Texas, United States, 76028

Retina Consultants of Texas /ID# 263274

Recruiting

Houston, Texas, United States, 77056-3030

Austin Retina Associates - Round Rock /ID# 266776

Recruiting

Round Rock, Texas, United States, 78681

Retina Consultants of Texas - Westover /ID# 264209

Recruiting

San Antonio, Texas, United States, 78251

Rocky Mountain Retina Consultants /ID# 263266

Recruiting

Murray, Utah, United States, 84107

Retina Centre of Ottawa /ID# 263803

Recruiting

Ottawa, Ontario, Canada, K2B 7E9

More Information

Sponsor

AbbVie

Last update posted

Sep 4, 2026

Last verified

Sep, 2026

Keywords

Neovascular age-related macular degeneration
Surabgene Lomparvovec
ABBV-RGX-314

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-07. This information was provided to ClinicalTrials.gov by AbbVie on 2026-09-04.