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  4. 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)

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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 (126) 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
Barnet Dulaney Perkins Eye Centers /ID# 279265
RECRUITING
Mesa
American Vision Partners /ID# 264615
RECRUITING
Sun City
California
Retinal Diagnostic Center /ID# 263054
RECRUITING
Campbell
The Retina Partners /ID# 263265
RECRUITING
Encino
Retina Associates of Southern California /ID# 263056
RECRUITING
Huntington Beach
Northern California Retina Vitreous Associates - Mountain View /ID# 263990
RECRUITING
Mountain View
Retina Consultants of San Diego /ID# 264026
RECRUITING
Poway
Retina Consultants Of Southern California - Redlands /ID# 276496
RECRUITING
Redlands
Kaiser Permanente - Riverside Medical Center /ID# 263253
RECRUITING
Riverside
Retinal Consultants - Sacramento - Greenback Lane /ID# 263983
RECRUITING
Sacramento
UCSF, Wayne and Gladys Valley Center for Vision /ID# 263058
RECRUITING
San Francisco
Orange County Retina Medical Group /ID# 266612
RECRUITING
Santa Ana
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 Eye Specialists /ID# 276612
NOT_YET_RECRUITING
Jacksonville
Florida Retina Institute - Lake Mary /ID# 263288
RECRUITING
Lake Mary
New Vision Eye Center /ID# 276971
NOT_YET_RECRUITING
Vero Beach
Center for Retina and Macular Disease /ID# 264201
RECRUITING
Winter Haven
Georgia
Southeast Retina Center /ID# 263264
RECRUITING
Augusta
Georgia Retina - Marietta /ID# 266850
NOT_YET_RECRUITING
Marietta
Hawaii
Retina Consultants of Hawaii, Inc. /ID# 266359
NOT_YET_RECRUITING
‘aiea
Iowa
Wolfe Eye Clinic - West Des Moines /ID# 263270
RECRUITING
West Des Moines
Illinois
Springfield Clinic Main Campus /ID# 265202
RECRUITING
Springfield
Indiana
Midwest Eye Institute North Indianapolis /ID# 264031
RECRUITING
Carmel
Maryland
The Retina Care Center /ID# 263263
RECRUITING
Baltimore
Retina Specialist /ID# 264633
RECRUITING
Towson
Maine
Maine Eye Center - Marginal Way Campus /ID# 263251
RECRUITING
Portland
Michigan
Associated Retinal Consultants /ID# 263289
RECRUITING
Royal Oak
Minnesota
Retina Consultants of Minnesota (RCM) - Edina Retina Clinic /ID# 279427
RECRUITING
Edina
Mayo Clinic - Minnesota /ID# 263977
RECRUITING
Rochester
Missouri
Retina Institute - St. Louis /ID# 263985
RECRUITING
St Louis
New Jersey
Monmouth Retina Consultants /ID# 279252
RECRUITING
Little Silver
Ohio
Cleveland Clinic - Cleveland /ID# 264210
RECRUITING
Cleveland
Midwest Retina /ID# 263231
RECRUITING
Dublin
Pennsylvania
Erie Retina Research /ID# 263287
RECRUITING
Erie
South Carolina
Charleston Neuroscience Institute - Bluffton /ID# 264037
RECRUITING
Bluffton
Charleston Neuroscience Institute - Charleston /ID# 276425
RECRUITING
Charleston
Retina Consultants of South Carolina - Ladson /ID# 277596
RECRUITING
Ladson
Retina Consultants of America /ID# 264038
RECRUITING
Mt. Pleasant
Palmetto Retina Center - West Columbia /ID# 263254
NOT_YET_RECRUITING
West Columbia
Tennessee
Tennessee Retina /ID# 263238
NOT_YET_RECRUITING
Nashville
Texas
Retina Research Institute of Texas /ID# 263233
RECRUITING
Abilene
Austin Clinical Research, LLC /ID# 263229
RECRUITING
Austin
Austin Retina Associates - Austin /ID# 266770
RECRUITING
Austin
Star Retina /ID# 266386
RECRUITING
Burleson
Retina Consultants of Texas /ID# 263274
RECRUITING
Houston
Austin Retina Associates - Round Rock /ID# 266776
RECRUITING
Round Rock
Retina Consultants of Texas - Westover /ID# 264209
RECRUITING
San Antonio
Utah
Rocky Mountain Retina Consultants /ID# 263266
RECRUITING
Murray
Washington
Spokane Eye Clinic /ID# 276934
NOT_YET_RECRUITING
Spokane
Other Locations
Austria
Medizinische Universitaet Graz /ID# 264511
RECRUITING
Graz
Medizinische Universitaet Innsbruck /ID# 264502
RECRUITING
Innsbruck
Kepler Universitaetsklinikum GmbH /ID# 264493
RECRUITING
Linz
Belgium
UZ Gent /ID# 261300
RECRUITING
Ghent
Universitair Ziekenhuis Leuven /ID# 261302
RECRUITING
Leuven
Bulgaria
Specialized Eye Hospital for Active Treatment - Burgas OOD /ID# 275729
RECRUITING
Burgas
OCIPSMAED St. Luka /ID# 275727
RECRUITING
Plovdiv
Specialized Hospital for Active Treatment of Eye Diseases Zora /ID# 275730
RECRUITING
Sofia
Medical Center -Vereya /ID# 275728
RECRUITING
Stara Zagora
Canada
Retina Centre of Ottawa /ID# 263803
RECRUITING
Ottawa
Croatia
Klinicki Bolnicki Centar Zagreb /ID# 276047
RECRUITING
Grad Zagreb
Klinicka Bolnica Sveti Duh /ID# 275871
RECRUITING
Zagreb
Specijalna bolnica Svjetlost /ID# 276051
RECRUITING
Zagreb
France
CHU Bordeaux - Hopital Pellegrin /ID# 265123
RECRUITING
Bordeaux
Centre Hospitalier Intercommunal de Creteil /ID# 265080
RECRUITING
Créteil
Hopital Edouard Herriot /ID# 265072
RECRUITING
Lyon
Centre Monticelli Paradis d'Ophtalmologie /ID# 265120
RECRUITING
Marseille
Centre Hospitalier Universitaire de Nantes - L' Hopital l'hotel-Dieu /ID# 265077
RECRUITING
Nantes
Clinique Jules Verne /ID# 265076
RECRUITING
Nantes
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 265073
RECRUITING
Nice
Centre Hospitalier National d'Ophtalmologie Quinze-Vingts /ID# 265125
RECRUITING
Paris
Hôpital Fondation Adolphe de Rothschild /ID# 265081
RECRUITING
Paris
Germany
Charite Universitaetsmedizin Berlin - Campus Benjamin Franklin /ID# 266366
RECRUITING
Berlin
Universitaetsklinikum Bonn /ID# 264279
RECRUITING
Bonn
Universitaetsklinikum Freiburg /ID# 275449
RECRUITING
Freiburg Im Breisgau
Universitaetsmedizin Goettingen - Georg-August-Universitaet /ID# 264282
RECRUITING
Göttingen
Universitaetsklinikum Hamburg-Eppendorf /ID# 264280
RECRUITING
Hamburg
Medizinische Hochschule Hannover /ID# 264281
RECRUITING
Hanover
Universitaetsklinikum Schleswig-Holstein - Campus Luebeck /ID# 264284
RECRUITING
Lübeck
Klinikum Ludwigshafen /ID# 275448
RECRUITING
Ludwigshafen Am Rhein
LMU Klinikum - Campus Innenstadt /ID# 264285
RECRUITING
Munich
Universitaetsklinikum Tuebingen /ID# 264283
RECRUITING
Tübingen
Greece
General Hospital of Athens G. Gennimatas /ID# 264243
RECRUITING
Athens
University General Hospital Attikon /ID# 264914
RECRUITING
Athens
University General Hospital of Larissa /ID# 264247
RECRUITING
Larissa
Hungary
Budapest Retina Associates /ID# 265208
RECRUITING
Budapest
Debreceni Egyetem-Klinikai Kozpont /ID# 265453
RECRUITING
Debrecen
Ganglion Orvosi Kozpont /ID# 265210
RECRUITING
Pécs
Israel
The Lady Davis Carmel Medical Center /ID# 265618
RECRUITING
Haifa
Edith Wolfson Medical Center /ID# 266304
RECRUITING
Holon
Hadassah Medical Center-Hebrew University /ID# 264300
RECRUITING
Jerusalem
Rabin Medical Center /ID# 266449
RECRUITING
Petah Tikva
The Chaim Sheba Medical Center /ID# 264700
RECRUITING
Ramat Gan
Kaplan Medical Center /ID# 264399
RECRUITING
Rehovot
Tel Aviv Sourasky Medical Center /ID# 266246
RECRUITING
Tel Aviv
Yitzhak Shamir Medical Center /ID# 275679
RECRUITING
Ẕerifin
Italy
Azienda Ospedaliero Universitaria delle Marche /ID# 265305
RECRUITING
Ancona
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 276017
RECRUITING
Cona
Azienda Ospedaliero Universitaria Careggi /ID# 265739
RECRUITING
Florence
AUSL di Reggio Emilia - Arcispedale Santa Maria Nuova /ID# 265732
RECRUITING
Reggio Emilia
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Universita Cattolica /ID# 276032
RECRUITING
Rome
Portugal
Unidade Local de Saude de Coimbra /ID# 264657
RECRUITING
Coimbra
Unidade Local de Saude de Sao Jose, EPE /ID# 264655
RECRUITING
Lisbon
Unidade Local de Saude de Santo Antonio /ID# 264658
RECRUITING
Porto
Puerto Rico
Emanuelli Research & Development Center /ID# 264350
RECRUITING
Arecibo
Spain
Instituto Oftalmológico Fernández-Vega /ID# 263157
RECRUITING
Asturias
Centre d'Oftalmologia Barraquer /ID# 266631
RECRUITING
Barcelona
Hospital Universitari Vall d'Hebron /ID# 263301
RECRUITING
Barcelona
Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 263152
RECRUITING
Barcelona
Hospital Arruzafa /ID# 280175
RECRUITING
Córdoba
Hospital Universitario De Donostia /ID# 263155
RECRUITING
Donostia / San Sebastian
Hospital Universitario 12 de Octubre /ID# 263544
RECRUITING
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 263179
RECRUITING
Majadahonda
Hospital Universitario Virgen Macarena /ID# 263180
RECRUITING
Seville
Hospital Universitari i Politecnic La Fe /ID# 263441
RECRUITING
Valencia
Hospital Clinico Universitario Lozano Blesa /ID# 263158
RECRUITING
Zaragoza
United Kingdom
Bristol Eye Hospital /ID# 266155
RECRUITING
Bristol
Gloucestershire Royal Hospital /ID# 276072
RECRUITING
Gloucester
Liverpool University Hospitals NHS Foundation Trust /ID# 265854
RECRUITING
Liverpool
Moorfields Eye Hospital /ID# 267227
RECRUITING
London
The Retina Clinic London /ID# 266156
RECRUITING
London
Manchester Royal Eye Hospital /ID# 266153
NOT_YET_RECRUITING
Manchester
Sunderland Royal Hospital /ID# 266664
RECRUITING
Sunderland
Contact Information
Primary
ABBVIE CALL CENTER
abbvieclinicaltrials@abbvie.com
844-663-3742
Time Frame
Start Date: 2025-11-05
Estimated Completion Date: 2033-03
Participants
Target number of participants: 561
Treatments
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
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: AbbVie

This content was sourced from clinicaltrials.gov

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