Tests gene therapy surabgene lomparvovec against ranibizumab in wet macular degeneration
Tests surabgene lomparvovec, a gene therapy, in adults with wet age-related macular degeneration.
Plain-language title generated from the registry record
Registry title: 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)
Key facts
- Where
- Abilene, Augusta, Austin, Baltimore, Bluffton, Burleson, Campbell, Carmel, Charleston, Cleveland, Colorado Springs, Columbus, Deerfield Beach, Delray Beach, Dublin, Edina, Encino, Erie, Fort Myers, Houston, Huntington Beach, La Jolla, Ladson, Lakewood, Lenexa, Little Silver, Longmont, Mesa, Mountain View, Mt. Pleasant, Murray, Newport Beach, Oak Lawn, Orlando, Philadelphia, Portland, Poway, Rapid City, Redlands, Reno, Riverside, Rochester, Round Rock, Royal Oak, Sacramento, San Antonio, San Francisco, Santa Ana, Springfield, St Louis, Sun City, Towson, West Des Moines, and Winter Haven, United StatesSee the 55 sites
- Phase
- Phase 3
Where in United States
- Retina Research Institute of Texas /ID# 263233Abilene, United StatesTaking people
- Southeast Retina Center /ID# 263264Augusta, United StatesTaking people
- Austin Clinical Research, LLC /ID# 263229Austin, United StatesTaking people
- Austin Retina Associates - Austin /ID# 266770Austin, United StatesTaking people
- The Retina Care Center /ID# 263263Baltimore, United StatesTaking people
- Charleston Neuroscience Institute - Bluffton /ID# 264037Bluffton, United StatesTaking people
- Star Retina /ID# 266386Burleson, United StatesTaking people
- Retinal Diagnostic Center /ID# 263054Campbell, United StatesTaking people
- Retina Partners Midwest, P.C. /ID# 264031Carmel, United StatesTaking people
- Charleston Neuroscience Institute - Charleston /ID# 276425Charleston, United StatesTaking people
- Cleveland Clinic - Cleveland /ID# 264210Cleveland, United StatesTaking people
- Retina Consultants of Southern Colorado /ID# 263284Colorado Springs, United StatesTaking people
- Ohio State Havener Eye Institute - Columbus /ID# 263987Columbus, United StatesTaking people
- Advanced Research, LLC /ID# 276526Deerfield Beach, United StatesTaking people
- Segal Drug Trials, Inc /ID# 276966Delray Beach, United StatesTaking people
- Midwest Retina /ID# 263231Dublin, United StatesTaking people
- Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427Edina, United StatesTaking people
- The Retina Partners /ID# 263265Encino, United StatesTaking people
- Erie Retina Research /ID# 263287Erie, United StatesTaking people
- Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631Fort Myers, United StatesTaking people
- Retina Consultants of Texas /ID# 263274Houston, United StatesTaking people
- Retina Associates of Southern California /ID# 263056Huntington Beach, United StatesTaking people
- Shiley Eye Institute At Uc San Diego Health /ID# 276682La Jolla, United StatesTaking people
- Retina Consultants of South Carolina - Ladson /ID# 277596Ladson, United StatesTaking people
- Colorado Retina Associates /ID# 263247Lakewood, United StatesTaking people
- Retina Associates - Lenexa /ID# 264607Lenexa, United StatesTaking people
- Monmouth Retina Consultants /ID# 279252Little Silver, United StatesTaking people
- Advanced Vision Surgery Center /ID# 264208Longmont, United StatesTaking people
- Barnet Dulaney Perkins Eye Center - Mesa /ID# 279265Mesa, United StatesTaking people
- Northern California Retina Vitreous Associates - Mountain View /ID# 263990Mountain View, United StatesTaking people
- Retina Consultants of America /ID# 264038Mt. Pleasant, United StatesTaking people
- Rocky Mountain Retina Consultants /ID# 263266Murray, United StatesTaking people
- Eye Research Foundation /ID# 277345Newport Beach, United StatesTaking people
- Vision Medical Research /ID# 277102Oak Lawn, United StatesTaking people
- Florida Retina Institute - Orlando /ID# 263288Orlando, United StatesTaking people
- Mid Atlantic Retina - Philadelphia /ID# 263291Philadelphia, United StatesTaking people
- Maine Eye Center - Marginal Way Campus /ID# 263251Portland, United StatesTaking people
- Retina Consultants of San Diego /ID# 264026Poway, United StatesTaking people
- Black Hills Regional Eye Institute /ID# 279258Rapid City, United StatesTaking people
- Retina Consultants Of Southern California - Redlands /ID# 276496Redlands, United StatesTaking people
- Sierra Eye Associates /ID# 263240Reno, United StatesTaking people
- Kaiser Permanente - Riverside Medical Center /ID# 263253Riverside, United StatesTaking people
- Mayo Clinic - Minnesota /ID# 263977Rochester, United StatesTaking people
- Austin Retina Associates - Round Rock /ID# 266776Round Rock, United StatesTaking people
- Associated Retinal Consultants /ID# 263289Royal Oak, United StatesTaking people
- Retinal Consultants - Sacramento - Greenback Lane /ID# 263983Sacramento, United StatesTaking people
- Retina Consultants of Texas - Westover /ID# 264209San Antonio, United StatesTaking people
- UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058San Francisco, United StatesTaking people
- Orange County Retina Medical Group /ID# 266612Santa Ana, United StatesTaking people
- Springfield Clinic Main Campus /ID# 265202Springfield, United StatesTaking people
- Retina Institute - St. Louis /ID# 263985St Louis, United StatesTaking people
- American Vision Partners /ID# 264615Sun City, United StatesTaking people
- Retina Specialist /ID# 264633Towson, United StatesTaking people
- Wolfe Eye Clinic - West Des Moines /ID# 263270West Des Moines, United StatesTaking people
- Center for Retina and Macular Disease /ID# 264201Winter Haven, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- AbbVie
- Trial code
- NCT07007065EU 2024-512298-28-00
- Record updated
- 29 October 2026
- Original description
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).Read full original descriptionShow less
A Randomized, Controlled, Partially Masked, Phase 3b Study to Assess the Injection Burden, Efficacy, Safety, and Long-Term Preservation of Visual Acuity of Surabgene Lomparvovec (ABBV-RGX-314) in a Real-World Context in Subjects With Neovascular Age-Related Macular Degeneration (nAMD)
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.
Inclusion: 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: 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; Study eye with nAMD diagnosed > 4 years from Screening Visit 1; CNV or macular edema in the study eye that is secondary to any causes other than AMD; 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; Retinal pigment epithelial tear involving the central subfield (central 1 mm) in the study eye as determined by the central reading center.