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A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD

Status: Recruiting
Location: See all (181) locations...
Intervention Type: Biological, Genetic
Study Type: Interventional
Study Phase: Phase 3
SUMMARY

ABBV-RGX-314 (also known as RGX-314 and surabgene lomparvovec (sura-vec)) is being developed as a novel one-time gene therapy for the treatment of neovascular (wet) age-related macular degeneration (wet AMD). Wet AMD is characterized by loss of vision due to new, leaky blood vessel formation in the retina. Wet AMD is a significant cause of vision loss in the United States, Europe and Japan, with up to 2 million people living with wet AMD in these geographies alone. Current anti-vascular endothelial growth factor (VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every four to 12 weeks in frequency, to maintain efficacy. Due to the burden of treatment, patients often experience a decline in vision with reduced frequency of treatment over time. ABBV-RGX-314 is being developed as a potential one-time treatment for wet AMD.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 89
Healthy Volunteers: f
View:

• Age ≥ 50 years and ≤ 89 years

• An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye

• Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in the study eye previously treated with anti-VEGF

• Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye

• Willing and able to provide written, signed informed consent for this study

• Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry

• An ETDRS BCVA letter score between ≤ 83 and ≥ 40 in both eyes

• Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in both eyes

• Must be pseudophakic (at least 12 weeks postcataract surgery) in both eyes

• Willing and able to provide written, signed informed consent for this study

• Newcomers must have active disease in the study eye; crossover participants must have active disease in the eye not treated in the main study

Locations
United States
Arizona
Barnet Dulaney Eye Center-Phoenix /ID# 256340
RECRUITING
Phoenix
Retinal Research Institute /ID# 256238
RECRUITING
Phoenix
Retina Macula Institute of Arizona /ID# 271026
RECRUITING
Scottsdale
California
California Retina Consultants - Bakersfield /ID# 256240
RECRUITING
Bakersfield
Retina Vitreous Assoc Med Grp /ID# 256246
RECRUITING
Beverly Hills
Retinal Diagnostic Center /ID# 256262
RECRUITING
Campbell
The Retina Partners - Encino /ID# 259660
RECRUITING
Encino
Retina Consultants of Orange County /ID# 256267
ACTIVE_NOT_RECRUITING
Fullerton
Jacobs Retina Center at UCSD/ID# 256320
ACTIVE_NOT_RECRUITING
La Jolla
California Retina Consultants - Oxnard - North Ventura Road /ID# 262883
RECRUITING
Oxnard
Byers Eye Institute Stanford /ID# 262853
RECRUITING
Palo Alto
Retina Consultants of San Diego /ID# 256258
ACTIVE_NOT_RECRUITING
Poway
Kaiser Permanente - Riverside Medical Center /ID# 262413
RECRUITING
Riverside
Retinal Consultants Medical Group, Inc. - Greenback /ID# 256353
ACTIVE_NOT_RECRUITING
Sacramento
UC Davis Health Eye Center
ACTIVE_NOT_RECRUITING
Sacramento
Orange County Retina Medical Group /ID# 256286
RECRUITING
Santa Ana
Macula Retina Vitreous Center - Torrance /ID# 270247
RECRUITING
Torrance
Bay Area Retina Associates - Walnut Creek - Lennon Lane /ID# 268513
RECRUITING
Walnut Creek
Colorado
Retina Consultants of Southern Colorado /ID# 256285
RECRUITING
Colorado Springs
Southwest Retina Research Center /ID# 256261
ACTIVE_NOT_RECRUITING
Durango
Colorado Retina Associates /ID# 256378
COMPLETED
Lakewood
Advanced Vision Research Institute /ID# 256380
RECRUITING
Longmont
Connecticut
Retina Consultants, P.C. /ID# 273610
RECRUITING
Manchester
Florida
Rand Eye Institute /ID# 256337
COMPLETED
Deerfield Beach
National Ophthalmic Research Institute /ID# 256344
ACTIVE_NOT_RECRUITING
Fort Myers
Vitreoretinal Associates, P.A. /ID# 256266
ACTIVE_NOT_RECRUITING
Gainesville
Florida Retina Consultants /ID# 256321
RECRUITING
Lakeland
Florida Retina Institute - Orlando /ID# 256373
RECRUITING
Orlando
Retina Specialty Institute /ID# 256268
RECRUITING
Pensacola
Fort Lauderdale Eye Institute /ID# 266011
COMPLETED
Plantation
Retina Vitreous Associates of Florida - St. Petersburg /ID# 256279
RECRUITING
St. Petersburg
Center for Retina and Macular Disease /ID# 256335
RECRUITING
Winter Haven
Georgia
Georgia Retina - Marietta /ID# 256264
RECRUITING
Marietta
Hawaii
Retina Consultants of Hawaii /ID# 256278
RECRUITING
‘aiea
Iowa
Wolfe Eye Clinic - West Des Moines /ID# 256314
ACTIVE_NOT_RECRUITING
West Des Moines
Illinois
Northwestern Memorial Hospital - Department of Ophthalmology /ID# 256379
RECRUITING
Chicago
University Retina and Macula Associates /ID# 256288
ACTIVE_NOT_RECRUITING
Lemont
University Retina and Macula Associates /ID# 256287
COMPLETED
Oak Forest
Illinois Retina Associates - Oak Park /ID# 256375
ACTIVE_NOT_RECRUITING
Oak Park
Springfield Clinic - First /ID# 256371
RECRUITING
Springfield
Indiana
Retina Partners Midwest, PC /ID# 256277
RECRUITING
Indianapolis
John-Kenyon American Eye Institute -New Albany /ID# 256283
ACTIVE_NOT_RECRUITING
New Albany
Kansas
Retina Associates - Lenexa /ID# 258296
RECRUITING
Lenexa
Massachusetts
MA Eye & Ear Infirmary /ID# 262430
ACTIVE_NOT_RECRUITING
Boston
Ophthalmic Consultants of Boston /ID# 256233
RECRUITING
Boston
Vitreo Retinal Associates - Worcester /ID# 266008
RECRUITING
Worcester
Maryland
Johns Hopkins Hospital /ID# 256236
COMPLETED
Baltimore
Retina Specialists /ID# 256392
ACTIVE_NOT_RECRUITING
Baltimore
Mid Atlantic Retina Specialists - Hagerstown /ID# 256310
ACTIVE_NOT_RECRUITING
Hagerstown
Maine
Maine Eye Center - Marginal Way Campus /ID# 256391
RECRUITING
Portland
Michigan
Retina Associates of Michigan /ID# 256393
RECRUITING
Grand Blanc
Associated Retinal Consultants /ID# 256269
RECRUITING
Royal Oak
Minnesota
VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256272
RECRUITING
Edina
Mayo Clinic - Rochester /ID# 258295
RECRUITING
Rochester
Missouri
Mid America Surgery Center /ID# 258993
COMPLETED
Chesterfield
University of Missouri Hospital /ID# 262474
RECRUITING
Columbia
Washington University School of Medicine - St. Louis /ID# 256383
RECRUITING
St Louis
Mississippi
Mississippi Retina Associates /ID# 270934
RECRUITING
Madison
North Carolina
Asheville Eye Associates- Retina Division /ID# 256355
RECRUITING
Asheville
Duke University Medical Center /ID# 256245
RECRUITING
Durham
Graystone Eye /ID# 256424
RECRUITING
Hickory
New Jersey
Envision Ocular, LLC /ID# 256367
RECRUITING
Bloomfield
Monmouth Retina Consultants /ID# 275895
RECRUITING
Little Silver
Nevada
Sierra Eye Associates /ID# 256239
COMPLETED
Reno
New York
Columbia University of New York - Edward S. Harkness Eye Institute /ID# 256342
ACTIVE_NOT_RECRUITING
New York
Retina Associates of Western New York /ID# 256374
COMPLETED
Rochester
Ohio
Cincinnati Eye Institute /ID# 256247
RECRUITING
Cincinnati
Cleveland Clinic - Cleveland /ID# 256282
ACTIVE_NOT_RECRUITING
Cleveland
Retina Associates of Cleveland-Middleburg Heights /ID# 256280
ACTIVE_NOT_RECRUITING
Cleveland
Ohio State University /ID# 256275
RECRUITING
Columbus
Midwest Retina /ID# 276644
COMPLETED
Dublin
Oklahoma
Retina Vitreous Center, Research /ID# 256284
RECRUITING
Edmond
Pennsylvania
Mid Atlantic Retina /ID# 256232
ACTIVE_NOT_RECRUITING
Philadelphia
University of Pennsylvania /ID# 258995
ACTIVE_NOT_RECRUITING
Philadelphia
University of Pittsburgh Medical Center /ID# 258994
ACTIVE_NOT_RECRUITING
Pittsburgh
South Carolina
Charleston Neuroscience Institute - Beaufort /ID# 256385
RECRUITING
Beaufort
Charleston Neurosciences Institute /ID# 256351
RECRUITING
Charleston
Palmetto Retina Center-Florence /ID# 256244
COMPLETED
Florence
Charleston Neurosciences Institute /ID# 256336
RECRUITING
Ladson
South Dakota
Black Hills Regional Eye Institute /ID# 262872
RECRUITING
Rapid City
Tennessee
Southeastern Retina Associates - Chattanooga /ID# 258992
COMPLETED
Chattanooga
Charles Retina Institute /ID# 256237
COMPLETED
Germantown
Southeastern Retina Associates - Johnson City /ID# 256396
RECRUITING
Johnson City
Tennessee Retina - Nashville /ID# 256388
RECRUITING
Nashville
Vanderbilt University Medical Center /ID# 256372
RECRUITING
Nashville
Texas
Retina Research Institute of Texas /ID# 256263
COMPLETED
Abilene
Austin Clinical Research, LLC /ID# 256274
COMPLETED
Austin
Austin Research Center for Retina /ID# 256265
RECRUITING
Austin
Retina Consultants of Texas - Bellaire /ID# 256377
RECRUITING
Bellaire
Star Retina - Burleson /ID# 256376
ACTIVE_NOT_RECRUITING
Burleson
Texas Retina Associates /ID# 256259
RECRUITING
Dallas
Texas Retina Associates - Fort Worth /ID# 256326
RECRUITING
Fort Worth
Austin Retina Associates - Round Rock /ID# 256387
RECRUITING
Round Rock
Retina Associates of South Texas
RECRUITING
San Antonio
Retina Consultants of Texas /ID# 256382
RECRUITING
San Antonio
Retina Consultants of Texas/ID# 259661
RECRUITING
San Antonio
Retina Center Of Texas (Rct) - Southlake /ID# 256281
RECRUITING
Southlake
Utah
Rocky Mountain Retina Consultants /ID# 256369
ACTIVE_NOT_RECRUITING
Murray
Retina Associates of Utah /ID# 256276
RECRUITING
Salt Lake City
Virginia
Piedmont Eye Center /ID# 256386
COMPLETED
Lynchburg
Wagner Kapoor Research Institute - Norfolk /ID# 256260
COMPLETED
Norfolk
Retina Institute of Virginia /ID# 256394
COMPLETED
Richmond
Vistar Eye Center /ID# 271024
RECRUITING
Roanoke
Washington
Pacific Northwest Retina /ID# 258999
COMPLETED
Bellevue
Retina Center NW, PLLC /ID# 256395
RECRUITING
Silverdale
Spokane Eye Clinic /ID# 256338
ACTIVE_NOT_RECRUITING
Spokane
Wisconsin
Gundersen Health System - La Crosse Medical Center /ID# 276012
RECRUITING
La Crosse
Other Locations
Canada
Calgary Retina Consultants /ID# 258997
ACTIVE_NOT_RECRUITING
Calgary
Alberta Retina Consultants /ID# 265599
ACTIVE_NOT_RECRUITING
Edmonton
Vitreous Retina Macula Specialists of Toronto /ID# 258299
ACTIVE_NOT_RECRUITING
Etobicoke
Retina Surgical Associates /ID# 270958
ACTIVE_NOT_RECRUITING
New Westminster
Ottawa Hospital Research Institute /ID# 258998
ACTIVE_NOT_RECRUITING
Ottawa
Retina Centre of Ottawa /ID# 259659
ACTIVE_NOT_RECRUITING
Ottawa
CHU de Quebec-Universite Laval /ID# 258996
COMPLETED
Québec
Sunnybrook Research Institute /ID# 270690
ACTIVE_NOT_RECRUITING
Toronto
Toronto Retina Institute /ID# 265602
ACTIVE_NOT_RECRUITING
Toronto
University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 266014
COMPLETED
Vancouver
France
Centre Hosp Intercommunal de Creteil /ID# 262407
ACTIVE_NOT_RECRUITING
Créteil
CHU Dijon /ID# 262410
ACTIVE_NOT_RECRUITING
Dijon
Hôpital de la Croix Rousse - Groupement Hospitalier Nord /ID# 262409
ACTIVE_NOT_RECRUITING
Lyon
Clinique Juge /ID# 262417
ACTIVE_NOT_RECRUITING
Marseille
Clinique Honoré Cave /ID# 262225
ACTIVE_NOT_RECRUITING
Montauban
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 262408
ACTIVE_NOT_RECRUITING
Nantes
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 262418
ACTIVE_NOT_RECRUITING
Nice
AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 262406
ACTIVE_NOT_RECRUITING
Paris
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 262415
ACTIVE_NOT_RECRUITING
Paris
Chu De Toulouse - Hopital Pierre Paul Ricquet /ID# 262411
ACTIVE_NOT_RECRUITING
Toulouse
Germany
Universitaetsklinikum Bonn /ID# 262498
ACTIVE_NOT_RECRUITING
Bonn
Universitaetsklinikum Freiburg /ID# 262495
ACTIVE_NOT_RECRUITING
Freiburg Im Breisgau
Universitaetsklinikum Hamburg-Eppendorf /ID# 262493
ACTIVE_NOT_RECRUITING
Hamburg
Klinikum Ludwigshafen /ID# 262497
ACTIVE_NOT_RECRUITING
Ludwigshafen Am Rhein
Universitaetsklinikum Muenster /ID# 262499
ACTIVE_NOT_RECRUITING
Münster
Knappschaftsklinikum Saar /ID# 262496
COMPLETED
Püttlingen
Universitaetsklinikum Ulm /ID# 262494
ACTIVE_NOT_RECRUITING
Ulm
Hungary
Budapest Retina Intezet /ID# 262647
ACTIVE_NOT_RECRUITING
Budapest
Debreceni Egyetem-Klinikai Kozpont /ID# 262646
ACTIVE_NOT_RECRUITING
Debrecen
Ganglion Orvosi Központ /ID# 264550
ACTIVE_NOT_RECRUITING
Pécs
Italy
A.O.U. Consorziale Policlinico di Bari /ID# 262500
ACTIVE_NOT_RECRUITING
Bari
ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 263923
ACTIVE_NOT_RECRUITING
Chieti
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 262896
ACTIVE_NOT_RECRUITING
Cona
ASST Fatebenefratelli Sacco /ID# 263273
ACTIVE_NOT_RECRUITING
Milan
IRCCS Ospedale San Raffaele /ID# 263035
ACTIVE_NOT_RECRUITING
Milan
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 264074
ACTIVE_NOT_RECRUITING
Naples
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 263536
COMPLETED
Negrar
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 263037
ACTIVE_NOT_RECRUITING
Rome
IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 262897
COMPLETED
Rome
ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 263036
ACTIVE_NOT_RECRUITING
Udine
Japan
Juntendo University Hospital /ID# 258715
RECRUITING
Bunkyo-ku
Fukushima Medical University Hospital /ID# 258411
RECRUITING
Fukushima
Kagoshima University Hospital /ID# 257053
RECRUITING
Kagoshima
Kobe City Eye Hospital /ID# 256948
RECRUITING
Kobe
Kyoto University Hospital /ID# 267351
RECRUITING
Kyoto
University of Miyazaki Hospital /ID# 262879
RECRUITING
Miyazaki
Nagoya University Hospital /ID# 267350
RECRUITING
Nagoya
Hyogo Medical University Hospital /ID# 257893
RECRUITING
Nishinomiya-shi
Shiga University of Medical Science /ID# 266862
RECRUITING
Ōtsu
Puerto Rico
Emanuelli Research & Development Center LLC /ID# 256231
ACTIVE_NOT_RECRUITING
Arecibo
Spain
Hospital Santa Creu i Sant Pau /ID# 262637
ACTIVE_NOT_RECRUITING
Barcelona
Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 262644
COMPLETED
Barcelona
Instituto de Microcirugía Ocular /ID# 262642
COMPLETED
Barcelona
Hospital Arruzafa /ID# 262634
ACTIVE_NOT_RECRUITING
Córdoba
Hospital Universitari de Bellvitge /ID# 262641
ACTIVE_NOT_RECRUITING
L'hospitalet De Llobregat
Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 262633
ACTIVE_NOT_RECRUITING
Las Palmas De Gran Canaria
Clinica Baviera /ID# 270146
COMPLETED
Madrid
Hospital Universitario 12 de Octubre /ID# 262636
ACTIVE_NOT_RECRUITING
Madrid
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 262635
ACTIVE_NOT_RECRUITING
Majadahonda
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262632
ACTIVE_NOT_RECRUITING
Santiago De Compostela
United Kingdom
Stoke Mandeville Hospital /ID# 277343
ACTIVE_NOT_RECRUITING
Aylesbury
Bradford Royal Infirmary /ID# 273164
ACTIVE_NOT_RECRUITING
Bradford
Bristol Eye Hospital /ID# 271619
COMPLETED
Bristol
Gloucestershire Royal Hospital /ID# 277362
COMPLETED
Gloucester
Leeds Teaching Hospital /ID# 277366
COMPLETED
Leeds
Liverpool University Hospitals NHS Foundation Trust /ID# 262305
ACTIVE_NOT_RECRUITING
Liverpool
Moorfields Eye Hospital /ID# 263038
COMPLETED
London
The Retina Clinic London /ID# 262304
ACTIVE_NOT_RECRUITING
London
Western Eye Hospital /ID# 271621
ACTIVE_NOT_RECRUITING
London
Manchester University NHS Foundation Trust /ID# 262404
COMPLETED
Manchester
Royal Victoria Infirmary /ID# 277368
ACTIVE_NOT_RECRUITING
Newcastle Upon Tyne
Oxford University Hospitals NHS Foundation Trust /ID# 262306
ACTIVE_NOT_RECRUITING
Oxford
University Hospital Southampton NHS Foundation Trust /ID# 262307
ACTIVE_NOT_RECRUITING
Southampton
Sunderland Eye Infirmary /ID# 271620
COMPLETED
Sunderland
Contact Information
Primary
Patient Advocacy
Patientadvocacy@regenxbio.com
1-833-711-0349
Time Frame
Start Date: 2022-01-13
Estimated Completion Date: 2027-11
Participants
Target number of participants: 714
Treatments
Experimental: ABBV-RGX-314 Dose 1
ABBV-RGX-314 Dose 1 administered via subretinal delivery one time.
Experimental: ABBV-RGX-314 Dose 2
ABBV-RGX-314 Dose 2 administered via subretinal delivery one time.
Active_comparator: Control Arm
Aflibercept administered via intravitreal injection approximately every 8 weeks
Related Therapeutic Areas
Late-Onset Retinal Degeneration
Age-Related Macular Degeneration (ARMD)
Sponsors
Leads: AbbVie
Collaborators: REGENXBIO Inc.

This content was sourced from clinicaltrials.gov

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