Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
ASCENT
A Randomized, Partially Masked, Controlled, Phase 3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD
2 other identifiers
interventional
735
10 countries
181
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2022
Longer than P75 for phase_3
181 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 13, 2022
CompletedFirst Submitted
Initial submission to the registry
January 28, 2022
CompletedFirst Posted
Study publicly available on registry
June 7, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 1, 2027
August 3, 2026
July 1, 2026
4.7 years
January 28, 2022
July 30, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Mean change from baseline in Best Corrected Visual Acuity (BCVA)
To evaluate the noninferiority of ABBV-RGX-314 relative to aflibercept in mean change from Baseline BCVA at Week 54
At Week 54
Bilateral Treatment Substudy: Incidence of ocular AEs and any SAEs
AEs and SAEs through Week 50
Week 50
Secondary Outcomes (35)
Incidences of ocular and overall AEs
Through Week 54
Proportion of participants with improved BCVA
Week 54
Proportion of participants with worsened BCVA
Week 54
Proportion of participants (1) gaining or losing greater than 0 letters; (2) maintaining vision compared with baseline as per 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)
Week 54
- +30 more secondary outcomes
Study Arms (3)
ABBV-RGX-314 Dose 1
EXPERIMENTALABBV-RGX-314 Dose 1 administered via subretinal delivery one time.
ABBV-RGX-314 Dose 2
EXPERIMENTALABBV-RGX-314 Dose 2 administered via subretinal delivery one time.
Control Arm
ACTIVE COMPARATORAflibercept administered via intravitreal injection approximately every 8 weeks
Interventions
2.0 mg (0.05 mLsolution) administered by intravitreal injection approximately every 8 weeks after 3 monthly injections
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 1)
AAV8 vector containing a transgene for anti-VEGF Fab (Dose 2)
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- CNV or macular edema in the study eye secondary to any causes other than AMD
- Subfoveal fibrosis or atrophy in the study eye
- Any condition in the investigator's opinion that could limit VA improvement in the study eye
- Advanced glaucoma or history of secondary glaucoma in the study eye
- Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
- History of intraocular surgery in the study eye within 12 weeks prior to randomization
- 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
- Prior treatment with gene therapy
- CNV or macular edema in either eye secondary to any causes other than AMD
- Subfoveal fibrosis or atrophy in either eye
- Any condition in the investigator's opinion that could limit VA improvement in either eye
- Advanced glaucoma or history of secondary glaucoma in either eye
- Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
- History of intraocular surgery in either eye within 12 weeks prior to randomization
- 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.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
- REGENXBIO Inc.collaborator
Study Sites (181)
Barnet Dulaney Eye Center-Phoenix /ID# 256340
Phoenix, Arizona, 85016, United States
Retinal Research Institute /ID# 256238
Phoenix, Arizona, 85053, United States
Retina Macula Institute of Arizona /ID# 271026
Scottsdale, Arizona, 85255-4134, United States
California Retina Consultants - Bakersfield /ID# 256240
Bakersfield, California, 93309-1677, United States
Retina Vitreous Assoc Med Grp /ID# 256246
Beverly Hills, California, 90211, United States
Retinal Diagnostic Center /ID# 256262
Campbell, California, 95008, United States
The Retina Partners - Encino /ID# 259660
Encino, California, 91436, United States
Retina Consultants of Orange County /ID# 256267
Fullerton, California, 92835, United States
Jacobs Retina Center at UCSD/ID# 256320
La Jolla, California, 92093, United States
California Retina Consultants - Oxnard - North Ventura Road /ID# 262883
Oxnard, California, 93036, United States
Byers Eye Institute Stanford /ID# 262853
Palo Alto, California, 94303, United States
Retina Consultants of San Diego /ID# 256258
Poway, California, 92064-2530, United States
Kaiser Permanente - Riverside Medical Center /ID# 262413
Riverside, California, 92505, United States
UC Davis Health Eye Center
Sacramento, California, 95817, United States
Retinal Consultants Medical Group, Inc. - Greenback /ID# 256353
Sacramento, California, 95841, United States
Orange County Retina Medical Group /ID# 256286
Santa Ana, California, 92705, United States
Macula Retina Vitreous Center - Torrance /ID# 270247
Torrance, California, 90503, United States
Bay Area Retina Associates - Walnut Creek - Lennon Lane /ID# 268513
Walnut Creek, California, 94598, United States
Retina Consultants of Southern Colorado /ID# 256285
Colorado Springs, Colorado, 80909, United States
Southwest Retina Research Center /ID# 256261
Durango, Colorado, 81303, United States
Colorado Retina Associates /ID# 256378
Lakewood, Colorado, 80228, United States
Advanced Vision Research Institute /ID# 256380
Longmont, Colorado, 80503, United States
Retina Consultants, P.C. /ID# 273610
Manchester, Connecticut, 06042-3556, United States
Rand Eye Institute /ID# 256337
Deerfield Beach, Florida, 33064, United States
National Ophthalmic Research Institute /ID# 256344
Fort Myers, Florida, 33912-7125, United States
Vitreoretinal Associates, P.A. /ID# 256266
Gainesville, Florida, 32607, United States
Florida Retina Consultants /ID# 256321
Lakeland, Florida, 33805, United States
Florida Retina Institute - Orlando /ID# 256373
Orlando, Florida, 32806-1101, United States
Retina Specialty Institute /ID# 256268
Pensacola, Florida, 32503, United States
Fort Lauderdale Eye Institute /ID# 266011
Plantation, Florida, 33324, United States
Retina Vitreous Associates of Florida - St. Petersburg /ID# 256279
St. Petersburg, Florida, 33711-1141, United States
Center for Retina and Macular Disease /ID# 256335
Winter Haven, Florida, 33880, United States
Georgia Retina - Marietta /ID# 256264
Marietta, Georgia, 30060, United States
Retina Consultants of Hawaii /ID# 256278
‘Aiea, Hawaii, 96701, United States
Northwestern Memorial Hospital - Department of Ophthalmology /ID# 256379
Chicago, Illinois, 60611-2987, United States
University Retina and Macula Associates /ID# 256288
Lemont, Illinois, 60439, United States
University Retina and Macula Associates /ID# 256287
Oak Forest, Illinois, 60452, United States
Illinois Retina Associates - Oak Park /ID# 256375
Oak Park, Illinois, 60304, United States
Springfield Clinic - First /ID# 256371
Springfield, Illinois, 62702, United States
Retina Partners Midwest, PC /ID# 256277
Indianapolis, Indiana, 46290, United States
John-Kenyon American Eye Institute -New Albany /ID# 256283
New Albany, Indiana, 47150, United States
Wolfe Eye Clinic - West Des Moines /ID# 256314
West Des Moines, Iowa, 50266, United States
Retina Associates - Lenexa /ID# 258296
Lenexa, Kansas, 66215, United States
Maine Eye Center - Marginal Way Campus /ID# 256391
Portland, Maine, 04101, United States
Retina Specialists /ID# 256392
Baltimore, Maryland, 21204, United States
Johns Hopkins Hospital /ID# 256236
Baltimore, Maryland, 21287, United States
Mid Atlantic Retina Specialists - Hagerstown /ID# 256310
Hagerstown, Maryland, 21740-5965, United States
MA Eye & Ear Infirmary /ID# 262430
Boston, Massachusetts, 02114, United States
Ophthalmic Consultants of Boston /ID# 256233
Boston, Massachusetts, 02114, United States
Vitreo Retinal Associates - Worcester /ID# 266008
Worcester, Massachusetts, 01605, United States
Retina Associates of Michigan /ID# 256393
Grand Blanc, Michigan, 48439, United States
Associated Retinal Consultants /ID# 256269
Royal Oak, Michigan, 48073, United States
VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota /ID# 256272
Edina, Minnesota, 55435, United States
Mayo Clinic - Rochester /ID# 258295
Rochester, Minnesota, 55905-0001, United States
Mississippi Retina Associates /ID# 270934
Madison, Mississippi, 39110-2028, United States
Mid America Surgery Center /ID# 258993
Chesterfield, Missouri, 63017, United States
University of Missouri Hospital /ID# 262474
Columbia, Missouri, 65212, United States
Washington University School of Medicine - St. Louis /ID# 256383
St Louis, Missouri, 63108, United States
Sierra Eye Associates /ID# 256239
Reno, Nevada, 89502, United States
Envision Ocular, LLC /ID# 256367
Bloomfield, New Jersey, 07003, United States
Monmouth Retina Consultants /ID# 275895
Little Silver, New Jersey, 07739, United States
Columbia University of New York - Edward S. Harkness Eye Institute /ID# 256342
New York, New York, 10032, United States
Retina Associates of Western New York /ID# 256374
Rochester, New York, 14620, United States
Asheville Eye Associates- Retina Division /ID# 256355
Asheville, North Carolina, 28803, United States
Duke University Medical Center /ID# 256245
Durham, North Carolina, 27710, United States
Graystone Eye /ID# 256424
Hickory, North Carolina, 28602, United States
Cincinnati Eye Institute /ID# 256247
Cincinnati, Ohio, 45242-5664, United States
Retina Associates of Cleveland-Middleburg Heights /ID# 256280
Cleveland, Ohio, 44130, United States
Cleveland Clinic - Cleveland /ID# 256282
Cleveland, Ohio, 44195, United States
Ohio State University /ID# 256275
Columbus, Ohio, 43210, United States
Midwest Retina /ID# 276644
Dublin, Ohio, 43016, United States
Retina Vitreous Center, Research /ID# 256284
Edmond, Oklahoma, 73013, United States
University of Pennsylvania /ID# 258995
Philadelphia, Pennsylvania, 19104-5502, United States
Mid Atlantic Retina /ID# 256232
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center /ID# 258994
Pittsburgh, Pennsylvania, 15213, United States
Charleston Neuroscience Institute - Beaufort /ID# 256385
Beaufort, South Carolina, 29902-6216, United States
Charleston Neurosciences Institute /ID# 256351
Charleston, South Carolina, 29414-5896, United States
Palmetto Retina Center-Florence /ID# 256244
Florence, South Carolina, 29501, United States
Charleston Neurosciences Institute /ID# 256336
Ladson, South Carolina, 29414-5896, United States
Black Hills Regional Eye Institute /ID# 262872
Rapid City, South Dakota, 57701, United States
Southeastern Retina Associates - Chattanooga /ID# 258992
Chattanooga, Tennessee, 37421, United States
Charles Retina Institute /ID# 256237
Germantown, Tennessee, 38138, United States
Southeastern Retina Associates - Johnson City /ID# 256396
Johnson City, Tennessee, 37604, United States
Tennessee Retina - Nashville /ID# 256388
Nashville, Tennessee, 37203-1513, United States
Vanderbilt University Medical Center /ID# 256372
Nashville, Tennessee, 37232-0011, United States
Retina Research Institute of Texas /ID# 256263
Abilene, Texas, 79606-1224, United States
Austin Research Center for Retina /ID# 256265
Austin, Texas, 78705, United States
Austin Clinical Research, LLC /ID# 256274
Austin, Texas, 78750-2298, United States
Retina Consultants of Texas - Bellaire /ID# 256377
Bellaire, Texas, 77401, United States
Star Retina - Burleson /ID# 256376
Burleson, Texas, 76028, United States
Texas Retina Associates /ID# 256259
Dallas, Texas, 75231, United States
Texas Retina Associates - Fort Worth /ID# 256326
Fort Worth, Texas, 76104, United States
Austin Retina Associates - Round Rock /ID# 256387
Round Rock, Texas, 78681, United States
Retina Consultants of Texas/ID# 259661
San Antonio, Texas, 78240-1655, United States
Retina Associates of South Texas
San Antonio, Texas, 78240, United States
Retina Consultants of Texas /ID# 256382
San Antonio, Texas, 78251, United States
Retina Center Of Texas (Rct) - Southlake /ID# 256281
Southlake, Texas, 76092, United States
Rocky Mountain Retina Consultants /ID# 256369
Murray, Utah, 84107, United States
Retina Associates of Utah /ID# 256276
Salt Lake City, Utah, 84107, United States
Piedmont Eye Center /ID# 256386
Lynchburg, Virginia, 24502, United States
Wagner Kapoor Research Institute - Norfolk /ID# 256260
Norfolk, Virginia, 23502, United States
Retina Institute of Virginia /ID# 256394
Richmond, Virginia, 23235, United States
Vistar Eye Center /ID# 271024
Roanoke, Virginia, 24019, United States
Pacific Northwest Retina /ID# 258999
Bellevue, Washington, 98004, United States
Retina Center NW, PLLC /ID# 256395
Silverdale, Washington, 98383, United States
Spokane Eye Clinic /ID# 256338
Spokane, Washington, 99204, United States
Gundersen Health System - La Crosse Medical Center /ID# 276012
La Crosse, Wisconsin, 54601, United States
Calgary Retina Consultants /ID# 258997
Calgary, Alberta, T2H 0C8, Canada
Alberta Retina Consultants /ID# 265599
Edmonton, Alberta, T5H 0X5, Canada
Retina Surgical Associates /ID# 270958
New Westminster, British Columbia, V3L 5H1, Canada
University of British Columbia - Eye Care Centre, Vancouver General Hospital /ID# 266014
Vancouver, British Columbia, V5Z 3N9, Canada
Vitreous Retina Macula Specialists of Toronto /ID# 258299
Etobicoke, Ontario, M8X 2X3, Canada
Ottawa Hospital Research Institute /ID# 258998
Ottawa, Ontario, K1H 8L6, Canada
Retina Centre of Ottawa /ID# 259659
Ottawa, Ontario, K2B 7E9, Canada
Toronto Retina Institute /ID# 265602
Toronto, Ontario, M3C 0G9, Canada
Sunnybrook Research Institute /ID# 270690
Toronto, Ontario, M4N 3M5, Canada
CHU de Quebec-Universite Laval /ID# 258996
Québec, Quebec, G1R 2J6, Canada
Centre Hospitalier Universitaire de Nice - Hopital Pasteur /ID# 262418
Nice, Alpes-Maritimes, 06001, France
Hôpital de la Croix Rousse - Groupement Hospitalier Nord /ID# 262409
Lyon, Auvergne-Rhône-Alpes, 69004, France
CHU Dijon /ID# 262410
Dijon, Cote-d Or, 21000, France
Chu De Toulouse - Hopital Pierre Paul Ricquet /ID# 262411
Toulouse, Occitanie, 31059, France
Hopitaux Universitaires Paris Centre-Hopital Cochin /ID# 262415
Paris, Paris, 75679, France
Centre Hospitalier Universitaire de Nantes, Hotel Dieu -HME /ID# 262408
Nantes, Pays de la Loire Region, 44000, France
Clinique Juge /ID# 262417
Marseille, Provence-Alpes-Côte d'Azur Region, 13008, France
Centre Hosp Intercommunal de Creteil /ID# 262407
Créteil, Val-de-Marne, 94000, France
Clinique Honoré Cave /ID# 262225
Montauban, 82017, France
AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere /ID# 262406
Paris, 75010, France
Universitaetsklinikum Freiburg /ID# 262495
Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany
Universitaetsklinikum Ulm /ID# 262494
Ulm, Baden-Wurttemberg, 89081, Germany
Universitaetsklinikum Bonn /ID# 262498
Bonn, North Rhine-Westphalia, 53127, Germany
Universitaetsklinikum Muenster /ID# 262499
Münster, North Rhine-Westphalia, 48149, Germany
Klinikum Ludwigshafen /ID# 262497
Ludwigshafen am Rhein, Rhineland-Palatinate, 67063, Germany
Universitaetsklinikum Hamburg-Eppendorf /ID# 262493
Hamburg, 20246, Germany
Knappschaftsklinikum Saar /ID# 262496
Püttlingen, 66346, Germany
Debreceni Egyetem-Klinikai Kozpont /ID# 262646
Debrecen, Hajdú-Bihar, 4032, Hungary
Budapest Retina Intezet /ID# 262647
Budapest, 1133, Hungary
Ganglion Orvosi Központ /ID# 264550
Pécs, 7621, Hungary
Azienda Ospedaliero-Universitaria di Ferrara - Arcispedale S.Anna /ID# 262896
Cona, Ferrara, 44124, Italy
IRCCS Ospedale San Raffaele /ID# 263035
Milan, Milano, 20132, Italy
ASST Fatebenefratelli Sacco /ID# 263273
Milan, Milano, 20157, Italy
Azienda Ospedaliera Universitaria Luigi Vanvitelli /ID# 264074
Naples, Napoli, 80138, Italy
Fondazione Policlinico Universitario Agostino Gemelli IRCCS-Università Cattolica /ID# 263037
Rome, Roma, 00168, Italy
IRCCS Fondazione G.B. Bietti per lo studio e la ricerca in Oftalmologia- ONLUS /ID# 262897
Rome, Roma, 00184, Italy
IRCCS Ospedale Sacro Cuore Don Calabria /ID# 263536
Negrar, Verona, 37024, Italy
A.O.U. Consorziale Policlinico di Bari /ID# 262500
Bari, 70124, Italy
ASL 2 Abruzzo Lanciano-Vasto-Chieti /ID# 263923
Chieti, 67100, Italy
ASU FC - P.O. Universitario Santa Maria della Misericordia /ID# 263036
Udine, 33100, Italy
Nagoya University Hospital /ID# 267350
Nagoya, Aichi-ken, 466-8560, Japan
Fukushima Medical University Hospital /ID# 258411
Fukushima, Fukushima, 960-1295, Japan
Kobe City Eye Hospital /ID# 256948
Kobe, Hyōgo, 650-0047, Japan
Hyogo Medical University Hospital /ID# 257893
Nishinomiya-shi, Hyōgo, 663-8501, Japan
Kagoshima University Hospital /ID# 257053
Kagoshima, Kagoshima-ken, 890-8520, Japan
Kyoto University Hospital /ID# 267351
Kyoto, Kyoto, 606-8507, Japan
University of Miyazaki Hospital /ID# 262879
Miyazaki, Miyazaki, 889-1692, Japan
Shiga University of Medical Science /ID# 266862
Ōtsu, Shiga, 520-2192, Japan
Juntendo University Hospital /ID# 258715
Bunkyo-ku, Tokyo, 113-8431, Japan
Emanuelli Research & Development Center LLC /ID# 256231
Arecibo, 00612, Puerto Rico
Complejo Hospitalario Universitario de Santiago (CHUS) /ID# 262632
Santiago de Compostela, A Coruna, 15706, Spain
Hospital Universitari de Bellvitge /ID# 262641
L'Hospitalet de Llobregat, Barcelona, 08907, Spain
Hospital Arruzafa /ID# 262634
Córdoba, Cordoba, 14012, Spain
Complejo Hospitalario Universitario Insular-Materno Infantil de Gran Canaria /ID# 262633
Las Palmas de Gran Canaria, Las Palmas, 35016, Spain
Hospital Universitario Puerta de Hierro - Majadahonda /ID# 262635
Majadahonda, Madrid, 28222, Spain
Institut Clínic d'Oftalmologia (ICOF). Hospital Clínic d'Oftalmologia. /ID# 262644
Barcelona, 08028, Spain
Instituto de Microcirugía Ocular /ID# 262642
Barcelona, 08035, Spain
Hospital Santa Creu i Sant Pau /ID# 262637
Barcelona, 08041, Spain
Hospital Universitario 12 de Octubre /ID# 262636
Madrid, 28041, Spain
Clinica Baviera /ID# 270146
Madrid, 28046, Spain
Stoke Mandeville Hospital /ID# 277343
Aylesbury, Buckinghamshire, HP21 8AL, United Kingdom
Western Eye Hospital /ID# 271621
London, England, NW1 5QH, United Kingdom
Gloucestershire Royal Hospital /ID# 277362
Gloucester, Gloucestershire, GL1 3NN, United Kingdom
Moorfields Eye Hospital /ID# 263038
London, Greater London, EC1V 2PD, United Kingdom
The Retina Clinic London /ID# 262304
London, Greater London, W1G 7LB, United Kingdom
University Hospital Southampton NHS Foundation Trust /ID# 262307
Southampton, Hampshire, SO16 6YD, United Kingdom
Oxford University Hospitals NHS Foundation Trust /ID# 262306
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Leeds Teaching Hospital /ID# 277366
Leeds, West Yorkshire, LS9 7TF, United Kingdom
Bradford Royal Infirmary /ID# 273164
Bradford, BD9 6RJ, United Kingdom
Bristol Eye Hospital /ID# 271619
Bristol, BS1 2LX, United Kingdom
Liverpool University Hospitals NHS Foundation Trust /ID# 262305
Liverpool, L7 8XP, United Kingdom
Manchester University NHS Foundation Trust /ID# 262404
Manchester, M9 2AA, United Kingdom
Royal Victoria Infirmary /ID# 277368
Newcastle upon Tyne, NE1 4LP, United Kingdom
Sunderland Eye Infirmary /ID# 271620
Sunderland, SR2 9HP, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Masking Details
- ABBV-RGX-314 administration is performed as an outpatient surgical procedure in an operating room, while the active control, aflibercept, is administered via intravitreal injection in an office setting. This study will be partially masked which will include masking of key study assessors and study drug dose.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2022
First Posted
June 7, 2022
Study Start
January 13, 2022
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
November 1, 2027
Last Updated
August 3, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will not share