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)
AbbVie · NCT07007065
Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.
Key facts
- Compensation
- Not posted. Ask the study team before screening.
- Who can join
- Ages 50+ · All sexes
- Healthy volunteers
- Not accepted (a condition is required)
- Study type
- Interventional · Phase 3
- Target enrollment
- 561
- US sites recruiting
- 55
- Study start
- November 5, 2025
- Record last updated
- October 23, 2026
Status re-checked against ClinicalTrials.gov within the last 12 hours.
What the study is about
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.
Being studied: Surabgene Lomparvovec (ABBV-RGX-314); Ranibizumab Control
Conditions: Neovascular Age-related Macular Degeneration
Eligibility criteria
Copied from the official record. The study team makes the final decision at screening.
Show full criteria
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.
Recruiting US locations
Barnet Dulaney Perkins Eye Center - Mesa /ID# 279265
Mesa, AZ 85206
American Vision Partners /ID# 264615
Sun City, AZ 85351
Retinal Diagnostic Center /ID# 263054
Campbell, CA 95008
The Retina Partners /ID# 263265
Encino, CA 91436
Retina Associates of Southern California /ID# 263056
Huntington Beach, CA 92647
Shiley Eye Institute At Uc San Diego Health /ID# 276682
La Jolla, CA 92093
Northern California Retina Vitreous Associates - Mountain View /ID# 263990
Mountain View, CA 94040-4119
Eye Research Foundation /ID# 277345
Newport Beach, CA 92663
Retina Consultants of San Diego /ID# 264026
Poway, CA 92064-2530
Retina Consultants Of Southern California - Redlands /ID# 276496
Redlands, CA 92374
Kaiser Permanente - Riverside Medical Center /ID# 263253
Riverside, CA 92505
Retinal Consultants - Sacramento - Greenback Lane /ID# 263983
Sacramento, CA 95841
UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058
San Francisco, CA 94143-2510
Orange County Retina Medical Group /ID# 266612
Santa Ana, CA 92705
Retina Consultants of Southern Colorado /ID# 263284
Colorado Springs, CO 80909
Colorado Retina Associates /ID# 263247
Lakewood, CO 80228
Advanced Vision Surgery Center /ID# 264208
Longmont, CO 80503
Advanced Research, LLC /ID# 276526
Deerfield Beach, FL 33064-1346
Segal Drug Trials, Inc /ID# 276966
Delray Beach, FL 33484
Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631
Fort Myers, FL 33917
Florida Retina Institute - Orlando /ID# 263288
Orlando, FL 32806
Center for Retina and Macular Disease /ID# 264201
Winter Haven, FL 33880
Southeast Retina Center /ID# 263264
Augusta, GA 30909
Vision Medical Research /ID# 277102
Oak Lawn, IL 60453
Springfield Clinic Main Campus /ID# 265202
Springfield, IL 62703-2403
Midwest Eye Institute North Indianapolis /ID# 264031
Carmel, IN 46290
Wolfe Eye Clinic - West Des Moines /ID# 263270
West Des Moines, IA 50266
Retina Associates - Lenexa /ID# 264607
Lenexa, KS 66215
Maine Eye Center - Marginal Way Campus /ID# 263251
Portland, ME 04101
The Retina Care Center /ID# 263263
Baltimore, MD 21209
Retina Specialist /ID# 264633
Towson, MD 21204
Associated Retinal Consultants /ID# 263289
Royal Oak, MI 48073
Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427
Edina, MN 55435
Mayo Clinic - Minnesota /ID# 263977
Rochester, MN 55905
Retina Institute - St. Louis /ID# 263985
St Louis, MO 63128
Sierra Eye Associates /ID# 263240
Reno, NV 89502
Monmouth Retina Consultants /ID# 279252
Little Silver, NJ 07739
Cleveland Clinic - Cleveland /ID# 264210
Cleveland, OH 44195
Ohio State Havener Eye Institute - Columbus /ID# 263987
Columbus, OH 43212
Midwest Retina /ID# 263231
Dublin, OH 43016
Erie Retina Research /ID# 263287
Erie, PA 16507
Mid Atlantic Retina - Philadelphia /ID# 263291
Philadelphia, PA 19107
Charleston Neuroscience Institute - Bluffton /ID# 264037
Bluffton, SC 29910
Charleston Neuroscience Institute - Charleston /ID# 276425
Charleston, SC 29414
Retina Consultants of South Carolina - Ladson /ID# 277596
Ladson, SC 29456
Retina Consultants of America /ID# 264038
Mt. Pleasant, SC 29464
Black Hills Regional Eye Institute /ID# 279258
Rapid City, SD 57701
Retina Research Institute of Texas /ID# 263233
Abilene, TX 79606
Austin Retina Associates - Austin /ID# 266770
Austin, TX 78705
Austin Clinical Research, LLC /ID# 263229
Austin, TX 78750-2298
Star Retina /ID# 266386
Burleson, TX 76028
Retina Consultants of Texas /ID# 263274
Houston, TX 77056-3030
Austin Retina Associates - Round Rock /ID# 266776
Round Rock, TX 78681
Retina Consultants of Texas - Westover /ID# 264209
San Antonio, TX 78251
Rocky Mountain Retina Consultants /ID# 263266
Murray, UT 84107
Study contacts (from the official record)
- ABBVIE CALL CENTER · 844-663-3742 · abbvieclinicaltrials@abbvie.com