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)
Status: Recruiting
Location: See all (44) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Healthy Volunteers: f
View:
• 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)
Locations
United States
Arizona
American Vision Partners /ID# 264615
RECRUITING
Sun City
California
Retinal Diagnostic Center /ID# 263054
RECRUITING
Campbell
The Retina Partners /ID# 263265
RECRUITING
Encino
Retinal Consultants - Sacramento - Greenback Lane /ID# 263983
RECRUITING
Sacramento
Colorado
Retina Consultants of Southern Colorado /ID# 263284
RECRUITING
Colorado Springs
Colorado Retina Associates /ID# 263247
RECRUITING
Lakewood
Advanced Vision Surgery Center /ID# 264208
RECRUITING
Longmont
Florida
Advanced Research, LLC /ID# 276526
RECRUITING
Deerfield Beach
Retina Vitreous Consultants LLP business DBA as Retina Group of Florida /ID# 264631
RECRUITING
Fort Myers
Florida Retina Institute - Lake Mary /ID# 263288
RECRUITING
Lake Mary
Georgia
Southeast Retina Center /ID# 263264
RECRUITING
Augusta
Iowa
Wolfe Eye Clinic - West Des Moines /ID# 263270
RECRUITING
West Des Moines
Illinois
Springfield Clinic Main Campus /ID# 265202
RECRUITING
Springfield
Maryland
The Retina Care Center /ID# 263263
RECRUITING
Baltimore
Retina Specialist /ID# 264633
RECRUITING
Towson
Michigan
Associated Retinal Consultants /ID# 263289
RECRUITING
Royal Oak
Pennsylvania
Erie Retina Research /ID# 263287
RECRUITING
Erie
South Carolina
Charleston Neuroscience Institute /ID# 264037
RECRUITING
Bluffton
Charleston Neuroscience Institute /ID# 276425
RECRUITING
Charleston
Retina Consultants of South Carolina - Ladson /ID# 277596
RECRUITING
Ladson
Retina Consultants of America /ID# 264038
RECRUITING
Mt. Pleasant
Texas
Austin Clinical Research, LLC /ID# 263229
RECRUITING
Austin
Star Retina - Burleson /ID# 266386
RECRUITING
Burleson
Retina Consultants of Texas - Westover /ID# 264209
RECRUITING
San Antonio
Other Locations
Austria
Medizinische Universitaet Innsbruck /ID# 264502
RECRUITING
Innsbruck
Kepler Universitaetsklinikum GmbH /ID# 264493
RECRUITING
Linz
Bulgaria
Medical Center -Vereya /ID# 275728
RECRUITING
Stara Zagora
Canada
Retina Centre of Ottawa /ID# 263803
RECRUITING
Ottawa
France
Centre Hospitalier Intercommunal de Creteil /ID# 265080
RECRUITING
Créteil
Hopital Edouard Herriot /ID# 265072
RECRUITING
Lyon
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hôtel-Dieu /ID# 265077