Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD (ASCENT)

July 30, 2026 updated by: AbbVie

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

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Detailed Description

This randomized, partially masked, controlled, Phase 3 clinical study will evaluate the efficacy and safety of ABBV-RGX-314 gene therapy in participants with nAMD. The study will evaluate 2 dose levels of RGX-314 gene therapy relative to an active comparator. The primary endpoint of this study is mean change in best-corrected visual acuity (BCVA) of ABBV-RGX-314 relative to aflibercept. Approximately 714 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms.

A bilateral treatment substudy conducted at US sites is an open-label, partially randomized, parallel arm study to evaluate the safety and efficacy of subretinal ABBV-RGX-314 administered bilaterally in participants who have bilateral nAMD. Previously treated crossover participants from the control arm of the main study who crossed over and received ABBV-RGX-314 in the study eye will receive the same ABBV-RGX-314 dose in the contralateral eye (ie, same dose as in the study eye), while newcomers (participants who have not been randomized in an ABBV-RGX-314 study) and untreated crossover participants (ongoing control participants in the main study who have completed Week 54 but have not crossed over to receive ABBV-RGX-314 in the main study) will be randomized in a 2:1 ratio to receive ABBV-RGX-314 Dose 1 or ABBV-RGX-314 Dose 2 in both eyes. Up to 15 participants who qualify for the substudy will be enrolled and followed for a minimum of 50 weeks.

Study Type

Interventional

Enrollment (Actual)

735

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T2H 0C8
        • Calgary Retina Consultants /ID# 258997
      • Edmonton, Alberta, Canada, T5H 0X5
        • Alberta Retina Consultants /ID# 265599
    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 5H1
        • Retina Surgical Associates /ID# 270958
      • Vancouver, British Columbia, Canada, V5Z 3N9
        • University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 266014
    • Ontario
      • Etobicoke, Ontario, Canada, M8X 2X3
        • Vitreous Retina Macula Specialists of Toronto /ID# 258299
      • Ottawa, Ontario, Canada, K1H 8L6
        • Ottawa Hospital Research Institute /ID# 258998
      • Ottawa, Ontario, Canada, K2B 7E9
        • Retina Centre of Ottawa /ID# 259659
      • Toronto, Ontario, Canada, M3C 0G9
        • Toronto Retina Institute /ID# 265602
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Research Institute /ID# 270690
    • Quebec
      • Québec, Quebec, Canada, G1R 2J6
        • CHU de Quebec-Universite Laval /ID# 258996
  • France
      • Montauban, France, 82017
        • Clinique Honoré Cave /ID# 262225
      • Paris, France, 75010
        • AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 262406
    • Alpes-Maritimes
      • Nice, Alpes-Maritimes, France, 06001
        • Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 262418
    • Auvergne-Rhône-Alpes
      • Lyon, Auvergne-Rhône-Alpes, France, 69004
        • Hôpital de la Croix Rousse - Groupement Hospitalier Nord /ID# 262409
    • Cote-d Or
      • Dijon, Cote-d Or, France, 21000
        • CHU Dijon /ID# 262410
    • Occitanie
      • Toulouse, Occitanie, France, 31059
        • Chu De Toulouse - Hopital Pierre Paul Ricquet /ID# 262411
    • Paris
      • Paris, Paris, France, 75679
        • Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 262415
    • Pays de la Loire Region
      • Nantes, Pays de la Loire Region, France, 44000
        • Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 262408
    • Provence-Alpes-Côte d'Azur Region
      • Marseille, Provence-Alpes-Côte d'Azur Region, France, 13008
        • Clinique Juge /ID# 262417
    • Val-de-Marne
      • Créteil, Val-de-Marne, France, 94000
        • Centre Hosp Intercommunal de Creteil /ID# 262407
  • Germany
      • Hamburg, Germany, 20246
        • Universitaetsklinikum Hamburg-Eppendorf /ID# 262493
      • Püttlingen, Germany, 66346
        • Knappschaftsklinikum Saar /ID# 262496
    • Baden-Wurttemberg
      • Freiburg im Breisgau, Baden-Wurttemberg, Germany, 79106
        • Universitaetsklinikum Freiburg /ID# 262495
      • Ulm, Baden-Wurttemberg, Germany, 89081
        • Universitaetsklinikum Ulm /ID# 262494
    • North Rhine-Westphalia
      • Bonn, North Rhine-Westphalia, Germany, 53127
        • Universitaetsklinikum Bonn /ID# 262498
      • Münster, North Rhine-Westphalia, Germany, 48149
        • Universitaetsklinikum Muenster /ID# 262499
    • Rhineland-Palatinate
      • Ludwigshafen am Rhein, Rhineland-Palatinate, Germany, 67063
        • Klinikum Ludwigshafen /ID# 262497
  • Hungary
      • Budapest, Hungary, 1133
        • Budapest Retina Intezet /ID# 262647
      • Pécs, Hungary, 7621
        • Ganglion Orvosi Központ /ID# 264550
    • Hajdú-Bihar
      • Debrecen, Hajdú-Bihar, Hungary, 4032
        • Debreceni Egyetem-Klinikai Kozpont /ID# 262646
  • Italy
      • Bari, Italy, 70124
        • A.O.U. Consorziale Policlinico di Bari /ID# 262500
      • Chieti, Italy, 67100
        • ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 263923
      • Udine, Italy, 33100
        • ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 263036
    • Ferrara
      • Cona, Ferrara, Italy, 44124
        • Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 262896
    • Milano
      • Milan, Milano, Italy, 20132
        • IRCCS Ospedale San Raffaele /ID# 263035
      • Milan, Milano, Italy, 20157
        • ASST Fatebenefratelli Sacco /ID# 263273
    • Napoli
      • Naples, Napoli, Italy, 80138
        • Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 264074
    • Roma
      • Rome, Roma, Italy, 00168
        • Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 263037
      • Rome, Roma, Italy, 00184
        • IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 262897
    • Verona
      • Negrar, Verona, Italy, 37024
        • IRCCS Ospedale Sacro Cuore Don Calabria /ID# 263536
  • Japan
    • Aichi-ken
      • Nagoya, Aichi-ken, Japan, 466-8560
        • Nagoya University Hospital /ID# 267350
    • Fukushima
      • Fukushima, Fukushima, Japan, 960-1295
        • Fukushima Medical University Hospital /ID# 258411
    • Hyōgo
      • Kobe, Hyōgo, Japan, 650-0047
        • Kobe City Eye Hospital /ID# 256948
      • Nishinomiya-shi, Hyōgo, Japan, 663-8501
        • Hyogo Medical University Hospital /ID# 257893
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-8520
        • Kagoshima University Hospital /ID# 257053
    • Kyoto
      • Kyoto, Kyoto, Japan, 606-8507
        • Kyoto University Hospital /ID# 267351
    • Miyazaki
      • Miyazaki, Miyazaki, Japan, 889-1692
        • University of Miyazaki Hospital /ID# 262879
    • Shiga
      • Ōtsu, Shiga, Japan, 520-2192
        • Shiga University of Medical Science /ID# 266862
    • Tokyo
      • Bunkyo-ku, Tokyo, Japan, 113-8431
        • Juntendo University Hospital /ID# 258715
  • Puerto Rico
      • Arecibo, Puerto Rico, 00612
        • Emanuelli Research & Development Center LLC /ID# 256231
  • Spain
      • Barcelona, Spain, 08028
        • Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 262644
      • Barcelona, Spain, 08035
        • Instituto de Microcirugía Ocular /ID# 262642
      • Barcelona, Spain, 08041
        • Hospital Santa Creu i Sant Pau /ID# 262637
      • Madrid, Spain, 28041
        • Hospital Universitario 12 de Octubre /ID# 262636
      • Madrid, Spain, 28046
        • Clinica Baviera /ID# 270146
    • A Coruna
      • Santiago de Compostela, A Coruna, Spain, 15706
        • Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262632
    • Barcelona
      • L'Hospitalet de Llobregat, Barcelona, Spain, 08907
        • Hospital Universitari de Bellvitge /ID# 262641
    • Cordoba
      • Córdoba, Cordoba, Spain, 14012
        • Hospital Arruzafa /ID# 262634
    • Las Palmas
      • Las Palmas de Gran Canaria, Las Palmas, Spain, 35016
        • Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 262633
    • Madrid
      • Majadahonda, Madrid, Spain, 28222
        • Hospital Universitario Puerta de Hierro - Majadahonda /ID# 262635
  • United Kingdom
      • Bradford, United Kingdom, BD9 6RJ
        • Bradford Royal Infirmary /ID# 273164
      • Bristol, United Kingdom, BS1 2LX
        • Bristol Eye Hospital /ID# 271619
      • Liverpool, United Kingdom, L7 8XP
        • Liverpool University Hospitals NHS Foundation Trust /ID# 262305
      • Manchester, United Kingdom, M9 2AA
        • Manchester University NHS Foundation Trust /ID# 262404
      • Newcastle upon Tyne, United Kingdom, NE1 4LP
        • Royal Victoria Infirmary /ID# 277368
      • Sunderland, United Kingdom, SR2 9HP
        • Sunderland Eye Infirmary /ID# 271620
    • Buckinghamshire
      • Aylesbury, Buckinghamshire, United Kingdom, HP21 8AL
        • Stoke Mandeville Hospital /ID# 277343
    • England
      • London, England, United Kingdom, NW1 5QH
        • Western Eye Hospital /ID# 271621
    • Gloucestershire
      • Gloucester, Gloucestershire, United Kingdom, GL1 3NN
        • Gloucestershire Royal Hospital /ID# 277362
    • Greater London
      • London, Greater London, United Kingdom, EC1V 2PD
        • Moorfields Eye Hospital /ID# 263038
      • London, Greater London, United Kingdom, W1G 7LB
        • The Retina Clinic London /ID# 262304
    • Hampshire
      • Southampton, Hampshire, United Kingdom, SO16 6YD
        • University Hospital Southampton NHS Foundation Trust /ID# 262307
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom, OX3 9DU
        • Oxford University Hospitals NHS Foundation Trust /ID# 262306
    • West Yorkshire
      • Leeds, West Yorkshire, United Kingdom, LS9 7TF
        • Leeds Teaching Hospital /ID# 277366
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85016
        • Barnet Dulaney Eye Center-Phoenix /ID# 256340
      • Phoenix, Arizona, United States, 85053
        • Retinal Research Institute /ID# 256238
      • Scottsdale, Arizona, United States, 85255-4134
        • Retina Macula Institute of Arizona /ID# 271026
    • California
      • Bakersfield, California, United States, 93309-1677
        • California Retina Consultants - Bakersfield /ID# 256240
      • Beverly Hills, California, United States, 90211
        • Retina Vitreous Assoc Med Grp /ID# 256246
      • Campbell, California, United States, 95008
        • Retinal Diagnostic Center /ID# 256262
      • Encino, California, United States, 91436
        • The Retina Partners - Encino /ID# 259660
      • Fullerton, California, United States, 92835
        • Retina Consultants of Orange County /ID# 256267
      • La Jolla, California, United States, 92093
        • Jacobs Retina Center at UCSD/ID# 256320
      • Oxnard, California, United States, 93036
        • California Retina Consultants - Oxnard - North Ventura Road /ID# 262883
      • Palo Alto, California, United States, 94303
        • Byers Eye Institute Stanford /ID# 262853
      • Poway, California, United States, 92064-2530
        • Retina Consultants of San Diego /ID# 256258
      • Riverside, California, United States, 92505
        • Kaiser Permanente - Riverside Medical Center /ID# 262413
      • Sacramento, California, United States, 95817
        • UC Davis Health Eye Center
      • Sacramento, California, United States, 95841
        • Retinal Consultants Medical Group, Inc. - Greenback /ID# 256353
      • Santa Ana, California, United States, 92705
        • Orange County Retina Medical Group /ID# 256286
      • Torrance, California, United States, 90503
        • Macula Retina Vitreous Center - Torrance /ID# 270247
      • Walnut Creek, California, United States, 94598
        • Bay Area Retina Associates - Walnut Creek - Lennon Lane /ID# 268513
    • Colorado
      • Colorado Springs, Colorado, United States, 80909
        • Retina Consultants of Southern Colorado /ID# 256285
      • Durango, Colorado, United States, 81303
        • Southwest Retina Research Center /ID# 256261
      • Lakewood, Colorado, United States, 80228
        • Colorado Retina Associates /ID# 256378
      • Longmont, Colorado, United States, 80503
        • Advanced Vision Research Institute /ID# 256380
    • Connecticut
      • Manchester, Connecticut, United States, 06042-3556
        • Retina Consultants, P.C. /ID# 273610
    • Florida
      • Deerfield Beach, Florida, United States, 33064
        • Rand Eye Institute /ID# 256337
      • Fort Myers, Florida, United States, 33912-7125
        • National Ophthalmic Research Institute /ID# 256344
      • Gainesville, Florida, United States, 32607
        • Vitreoretinal Associates, P.A. /ID# 256266
      • Lakeland, Florida, United States, 33805
        • Florida Retina Consultants /ID# 256321
      • Orlando, Florida, United States, 32806-1101
        • Florida Retina Institute - Orlando /ID# 256373
      • Pensacola, Florida, United States, 32503
        • Retina Specialty Institute /ID# 256268
      • Plantation, Florida, United States, 33324
        • Fort Lauderdale Eye Institute /ID# 266011
      • St. Petersburg, Florida, United States, 33711-1141
        • Retina Vitreous Associates of Florida - St. Petersburg /ID# 256279
      • Winter Haven, Florida, United States, 33880
        • Center for Retina and Macular Disease /ID# 256335
    • Georgia
      • Marietta, Georgia, United States, 30060
        • Georgia Retina - Marietta /ID# 256264
    • Hawaii
      • ‘Aiea, Hawaii, United States, 96701
        • Retina Consultants of Hawaii /ID# 256278
    • Illinois
      • Chicago, Illinois, United States, 60611-2987
        • Northwestern Memorial Hospital - Department of Ophthalmology /ID# 256379
      • Lemont, Illinois, United States, 60439
        • University Retina and Macula Associates /ID# 256288
      • Oak Forest, Illinois, United States, 60452
        • University Retina and Macula Associates /ID# 256287
      • Oak Park, Illinois, United States, 60304
        • Illinois Retina Associates - Oak Park /ID# 256375
      • Springfield, Illinois, United States, 62702
        • Springfield Clinic - First /ID# 256371
    • Indiana
      • Indianapolis, Indiana, United States, 46290
        • Retina Partners Midwest, PC /ID# 256277
      • New Albany, Indiana, United States, 47150
        • John-Kenyon American Eye Institute -New Albany /ID# 256283
    • Iowa
      • West Des Moines, Iowa, United States, 50266
        • Wolfe Eye Clinic - West Des Moines /ID# 256314
    • Kansas
      • Lenexa, Kansas, United States, 66215
        • Retina Associates - Lenexa /ID# 258296
    • Maine
      • Portland, Maine, United States, 04101
        • Maine Eye Center - Marginal Way Campus /ID# 256391
    • Maryland
      • Baltimore, Maryland, United States, 21204
        • Retina Specialists /ID# 256392
      • Baltimore, Maryland, United States, 21287
        • Johns Hopkins Hospital /ID# 256236
      • Hagerstown, Maryland, United States, 21740-5965
        • Mid Atlantic Retina Specialists - Hagerstown /ID# 256310
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • MA Eye & Ear Infirmary /ID# 262430
      • Boston, Massachusetts, United States, 02114
        • Ophthalmic Consultants of Boston /ID# 256233
      • Worcester, Massachusetts, United States, 01605
        • Vitreo Retinal Associates - Worcester /ID# 266008
    • Michigan
      • Grand Blanc, Michigan, United States, 48439
        • Retina Associates of Michigan /ID# 256393
      • Royal Oak, Michigan, United States, 48073
        • Associated Retinal Consultants /ID# 256269
    • Minnesota
      • Edina, Minnesota, United States, 55435
        • VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256272
      • Rochester, Minnesota, United States, 55905-0001
        • Mayo Clinic - Rochester /ID# 258295
    • Mississippi
      • Madison, Mississippi, United States, 39110-2028
        • Mississippi Retina Associates /ID# 270934
    • Missouri
      • Chesterfield, Missouri, United States, 63017
        • Mid America Surgery Center /ID# 258993
      • Columbia, Missouri, United States, 65212
        • University of Missouri Hospital /ID# 262474
      • St Louis, Missouri, United States, 63108
        • Washington University School of Medicine - St. Louis /ID# 256383
    • Nevada
      • Reno, Nevada, United States, 89502
        • Sierra Eye Associates /ID# 256239
    • New Jersey
      • Bloomfield, New Jersey, United States, 07003
        • Envision Ocular, LLC /ID# 256367
      • Little Silver, New Jersey, United States, 07739
        • Monmouth Retina Consultants /ID# 275895
    • New York
      • New York, New York, United States, 10032
        • Columbia University of New York - Edward S. Harkness Eye Institute /ID# 256342
      • Rochester, New York, United States, 14620
        • Retina Associates of Western New York /ID# 256374
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Asheville Eye Associates- Retina Division /ID# 256355
      • Durham, North Carolina, United States, 27710
        • Duke University Medical Center /ID# 256245
      • Hickory, North Carolina, United States, 28602
        • Graystone Eye /ID# 256424
    • Ohio
      • Cincinnati, Ohio, United States, 45242-5664
        • Cincinnati Eye Institute /ID# 256247
      • Cleveland, Ohio, United States, 44130
        • Retina Associates of Cleveland-Middleburg Heights /ID# 256280
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic - Cleveland /ID# 256282
      • Columbus, Ohio, United States, 43210
        • Ohio State University /ID# 256275
      • Dublin, Ohio, United States, 43016
        • Midwest Retina /ID# 276644
    • Oklahoma
      • Edmond, Oklahoma, United States, 73013
        • Retina Vitreous Center, Research /ID# 256284
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104-5502
        • University of Pennsylvania /ID# 258995
      • Philadelphia, Pennsylvania, United States, 19107
        • Mid Atlantic Retina /ID# 256232
      • Pittsburgh, Pennsylvania, United States, 15213
        • University of Pittsburgh Medical Center /ID# 258994
    • South Carolina
      • Beaufort, South Carolina, United States, 29902-6216
        • Charleston Neuroscience Institute - Beaufort /ID# 256385
      • Charleston, South Carolina, United States, 29414-5896
        • Charleston Neurosciences Institute /ID# 256351
      • Florence, South Carolina, United States, 29501
        • Palmetto Retina Center-Florence /ID# 256244
      • Ladson, South Carolina, United States, 29414-5896
        • Charleston Neurosciences Institute /ID# 256336
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Black Hills Regional Eye Institute /ID# 262872
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • Southeastern Retina Associates - Chattanooga /ID# 258992
      • Germantown, Tennessee, United States, 38138
        • Charles Retina Institute /ID# 256237
      • Johnson City, Tennessee, United States, 37604
        • Southeastern Retina Associates - Johnson City /ID# 256396
      • Nashville, Tennessee, United States, 37203-1513
        • Tennessee Retina - Nashville /ID# 256388
      • Nashville, Tennessee, United States, 37232-0011
        • Vanderbilt University Medical Center /ID# 256372
    • Texas
      • Abilene, Texas, United States, 79606-1224
        • Retina Research Institute of Texas /ID# 256263
      • Austin, Texas, United States, 78705
        • Austin Research Center for Retina /ID# 256265
      • Austin, Texas, United States, 78750-2298
        • Austin Clinical Research, LLC /ID# 256274
      • Bellaire, Texas, United States, 77401
        • Retina Consultants of Texas - Bellaire /ID# 256377
      • Burleson, Texas, United States, 76028
        • Star Retina - Burleson /ID# 256376
      • Dallas, Texas, United States, 75231
        • Texas Retina Associates /ID# 256259
      • Fort Worth, Texas, United States, 76104
        • Texas Retina Associates - Fort Worth /ID# 256326
      • Round Rock, Texas, United States, 78681
        • Austin Retina Associates - Round Rock /ID# 256387
      • San Antonio, Texas, United States, 78240
        • Retina Associates of South Texas
      • San Antonio, Texas, United States, 78240-1655
        • Retina Consultants of Texas/ID# 259661
      • San Antonio, Texas, United States, 78251
        • Retina Consultants of Texas /ID# 256382
      • Southlake, Texas, United States, 76092
        • Retina Center Of Texas (Rct) - Southlake /ID# 256281
    • Utah
      • Murray, Utah, United States, 84107
        • Rocky Mountain Retina Consultants /ID# 256369
      • Salt Lake City, Utah, United States, 84107
        • Retina Associates of Utah /ID# 256276
    • Virginia
      • Lynchburg, Virginia, United States, 24502
        • Piedmont Eye Center /ID# 256386
      • Norfolk, Virginia, United States, 23502
        • Wagner Kapoor Research Institute - Norfolk /ID# 256260
      • Richmond, Virginia, United States, 23235
        • Retina Institute of Virginia /ID# 256394
      • Roanoke, Virginia, United States, 24019
        • Vistar Eye Center /ID# 271024
    • Washington
      • Bellevue, Washington, United States, 98004
        • Pacific Northwest Retina /ID# 258999
      • Silverdale, Washington, United States, 98383
        • Retina Center NW, PLLC /ID# 256395
      • Spokane, Washington, United States, 99204
        • Spokane Eye Clinic /ID# 256338
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Gundersen Health System - La Crosse Medical Center /ID# 276012

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

46 years to 85 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age ≥ 50 years and ≤ 89 years
  2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
  3. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in the study eye previously treated with anti-VEGF
  4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye
  5. Willing and able to provide written, signed informed consent for this study
  6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry

Inclusion Criteria (Bilateral Treatment Substudy)*:

  1. An ETDRS BCVA letter score between ≤ 83 and ≥ 40 in both eyes
  2. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in both eyes
  3. Must be pseudophakic (at least 12 weeks postcataract surgery) in both eyes
  4. Willing and able to provide written, signed informed consent for this study
  5. Newcomers must have active disease in the study eye; crossover participants must have active disease in the eye not treated in the main study

Exclusion Criteria:

  1. CNV or macular edema in the study eye secondary to any causes other than AMD
  2. Subfoveal fibrosis or atrophy in the study eye
  3. Any condition in the investigator's opinion that could limit VA improvement in the study eye
  4. Advanced glaucoma or history of secondary glaucoma in the study eye
  5. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
  6. History of intraocular surgery in the study eye within 12 weeks prior to randomization
  7. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational medicinal product, other than an intravitreal therapy for AMD, in the 6 months prior to Week -6
  8. Prior treatment with gene therapy

Exclusion Criteria (Bilateral Treatment Substudy)*:

  1. CNV or macular edema in either eye secondary to any causes other than AMD
  2. Subfoveal fibrosis or atrophy in either eye
  3. Any condition in the investigator's opinion that could limit VA improvement in either eye
  4. Advanced glaucoma or history of secondary glaucoma in either eye
  5. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
  6. History of intraocular surgery in either eye within 12 weeks prior to randomization
  7. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational medicinal product, other than an intravitreal therapy for AMD, in the 6 months prior to Week -6.
  8. Prior treatment with gene therapy (*) For previously treated crossover participants, criteria apply to the eye not treated in the main study only.

Note: Other inclusion/exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Arm
Aflibercept administered via intravitreal injection approximately every 8 weeks
Biological: Aflibercept (EYLEA®)
2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections
Other Names:
  • Eylea (anti-VEGF agent)
Experimental: ABBV-RGX-314 Dose 1
ABBV-RGX-314 Dose 1 administered via subretinal delivery one time.
Genetic: ABBV-RGX-314 Dose 1
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
Other Names:
  • RGX-314
  • surabgene lomparvovec
Experimental: ABBV-RGX-314 Dose 2
ABBV-RGX-314 Dose 2 administered via subretinal delivery one time.
Genetic: ABBV-RGX-314 Dose 2
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
Other Names:
  • RGX-314
  • surabgene lomparvovec

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs
Time Frame: Week 50
AEs and SAEs through Week 50
Week 50
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
Time Frame: At Week 54
To evaluate the noninferiority of ABBV-RGX-314 relative to aflibercept in mean change from Baseline BCVA at Week 54
At Week 54

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Bilateral Treatment Substudy: Mean change from Baseline in CRT at assessed time points
Time Frame: Through Week 50
Mean change in CRT as measured by SD-OCT
Through Week 50
Bilateral Treatment Substudy: Supplemental anti-VEGF injection annualized rate
Time Frame: Through Week 50
Supplemental anti-VEGF injection annualized rate
Through Week 50
Bilateral Treatment Substudy: Mean number of supplemental anti-VEGF injections
Time Frame: Through Week 50
Mean supplemental anti-VEGF injections
Through Week 50
Bilateral Treatment Substudy: Aqueous humor and serum ABBV-RGX-314 TP concentrations
Time Frame: Week 26, Week 34, Week 50
Aqueous humor and serum ABBV-RGX-314 TP concentrations
Week 26, Week 34, Week 50
Bilateral Treatment Substudy: Proportion of participants with 0, ≤ 1, ≤ 2, and ≤ 3 supplemental anti-VEGF injections
Time Frame: Through Week 50
Proportion of participants with 0, ≤ 1, ≤ 2, and ≤ 3 supplemental anti-VEGF injections
Through Week 50
Incidences of ocular and overall AEs
Time Frame: Through Week 54
To evaluate the safety and tolerability of ABBV-RGX-314 through Week 54
Through Week 54
Proportion of participants with improved BCVA
Time Frame: Week 54
To evaluate the effect of ABBV-RGX-314 relative to aflibercept on BCVA
Week 54
Proportion of participants with worsened BCVA
Time Frame: Week 54
To evaluate the effect of ABBV-RGX-314 relative to aflibercept on BCVA
Week 54
Proportion of participants (1) gaining or losing greater than 0 letters; (2) maintaining vision compared with baseline as per BCVA
Time Frame: Week 54
To evaluate the effect of ABBV-RGX-314 relative to aflibercept on BCVA
Week 54
Mean change from baseline in BCVA for participants who received 0 or more supplemental anti-VEGF injection (ABBV-RGX- 314 randomized participants)
Time Frame: Week 54
To evaluate the effect of ABBV-RGX-314 relative to aflibercept on BCVA
Week 54
Mean change from Week 54 to Week 108 in BCVA (control arm participants who cross over to ABBV-RGX-314)
Time Frame: Week 54 to Week 108
To evaluate the effect of ABBV-RGX-314 relative to aflibercept on BCVA
Week 54 to Week 108
Mean change in central retinal thickness (CRT) as measured by SD-OCT
Time Frame: Through Week 108
To evaluate the effect of ABBV-RGX-314 relative to aflibercept on CRT as measured by SD-OCT
Through Week 108
Mean change in central point thickness (CPT) as measured by SD-OCT
Time Frame: Through Week 108
To evaluate the effect of ABBV-RGX-314 relative to aflibercept on CPT as measured by SD-OCT
Through Week 108
Mean number of supplemental anti-VEGF injections from Baseline through Week 54 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 108 (control arm participants who cross over to ABBV-RGX-314)
Time Frame: Through Week 108
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 108
Proportion of participants with 0, 1, 2, and 3 supplemental injections through Week 54 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 108 (control arm participants who cross over to ABBV-RGX-314)
Time Frame: Through Week 108
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 108
Proportion of participants with ≤ 1, ≤ 2, and ≤ 3 supplemental injections through Week 54 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 108 (control arm participants who cross over to ABBV-RGX-314)
Time Frame: Through Week 108
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 108
Proportion of participants that received 1 or 2 injections through Week 54 (ABBV-RGX-314 randomized participants) and from Week 54 through Week 108 (control arm participants who cross over to ABBV-RGX-314)
Time Frame: Through Week 108
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 108
Proportion of participants with a reduction of ≥ 50% in anti-VEGF injection annualized rate through Week 54 compared with the prior year (ABBV-RGX-314 randomized participants)
Time Frame: Through Week 54
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 54
Proportion of participants with a reduction of ≥ 75% in anti-VEGF injection annualized rate through Week 54 compared with the prior year (ABBV-RGX-314 randomized participants)
Time Frame: Through Week 54
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 54
Percent reduction in anti-VEGF injection annualized rate through Week 54 compared with the prior year (ABBV-RGX-314 randomized participants)
Time Frame: Through Week 54
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 54
Supplemental anti-VEGF injection annualized rate through Week 54 (ABBV-RGX-314 randomized participants)
Time Frame: Through Week 54
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 54
Percent reduction in anti-VEGF injection annualized rate after Week 58 through Week 108 relative to the year prior to study (control arm participants who cross over to ABBV-RGX-314)
Time Frame: Through Week 108
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 108
Supplemental anti-VEGF injection annualized rate after Week 58 through Week 108 (control arm participants who cross over to ABBV-RGX-314)
Time Frame: Through Week 108
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 108
Time to first supplemental anti- VEGF injection after the Week 2 injection (ABBV-RGX-314 randomized participants)
Time Frame: Through Week 54
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 54
Time to first supplemental anti-VEGF injection after the Week 58 injection (control arm participants who cross over to ABBV-RGX-314)
Time Frame: Through Week 108
To assess the need for supplemental anti-VEGF therapy in participants treated with ABBV-RGX-314
Through Week 108
Mean change from Baseline in NEI VFQ-25 (composite score) at Week 54 and (control arm participants who cross over to ABBV-RGX-314) Week 108
Time Frame: Week 54 and Week 108
To evaluate patient-reported visual function and treatment satisfaction using PRO questionnaires
Week 54 and Week 108
Mean change from Baseline in MacTSQ (composite score) at Week 54 and (control arm participants who cross over to ABBV-RGX-314) Week 108
Time Frame: Week 54 and Week 108
To evaluate patient-reported visual function and treatment satisfaction using PRO questionnaires
Week 54 and Week 108
Aqueous humor ABBV-RGX-314 TP concentrations at Week -2, Week 14, Week 38, and Week 54 (ABBV-RGX-314 randomized participants)
Time Frame: Through Week 54
To assess aqueous humor and serum TP concentrations prior to and after ABBV-RGX-314 administration
Through Week 54
Aqueous humor ABBV-RGX-314 TP concentrations at Week 54, Week 74, Week 90, and Week 108 (control arm participants who cross over to ABBV-RGX-314)
Time Frame: Through Week 108
To assess aqueous humor and serum TP concentrations prior to and after ABBV-RGX-314 administration
Through Week 108
Serum ABBV-RGX-314 TP concentrations (at select sites)
Time Frame: Through Week 54
To assess aqueous humor and serum TP concentrations prior to and after ABBV-RGX-314 administration
Through Week 54
Immunogenicity measurements (ABBV-RGX-314 randomized participants)
Time Frame: Week -2, Week 14, Week 38, and Week 54
Immunogenicity measurements (serum antibodies to AAV8 and serum antibodies to ABBVRGX- 314 TP)
Week -2, Week 14, Week 38, and Week 54
Immunogenicity measurements (control arm participants who cross over to ABBV-RGX-314)
Time Frame: Week 54, Week 74, Week 90, and Week 108
Immunogenicity measurements (serum antibodies to AAV8 and serum antibodies to ABBV-RGX- 314 TP)
Week 54, Week 74, Week 90, and Week 108
Bilateral Treatment Substudy: Incidence of nonocular AEs and any AESIs
Time Frame: Week 50
To evaluate the safety and tolerability of bilateral treatment of ABBV-RGX-314 gene therapy
Week 50
Bilateral Treatment Substudy: Mean change from Baseline in BCVA at assessed time points
Time Frame: Week 50
BCVA measured by ETDRS
Week 50
Bilateral Treatment Substudy: Immunogenicity measurements (serum anti-ABBV-RGX-314 TP antibodies, serum anti-AAV8 antibodies) and enzyme-linked immunospot at assessed time points
Time Frame: Week 50
Immunogenicity measurements
Week 50

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Collaborators

REGENXBIO Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2022

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

November 1, 2027

Study Registration Dates

First Submitted

January 28, 2022

First Submitted That Met QC Criteria

June 2, 2022

First Posted (Actual)

June 7, 2022

Study Record Updates

Last Update Posted (Actual)

August 3, 2026

Last Update Submitted That Met QC Criteria

July 30, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RGX-314-3101
  • M23-409 (Other Identifier: AbbVie)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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