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

Last updated: October 14, 2024
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

3

Condition

Macular Degeneration

Geographic Atrophy

Treatment

ABBV-RGX-314 Dose 2

ABBV-RGX-314 Dose 1

RGX-314 Dose 1

Clinical Study ID

NCT05407636
RGX-314-3101
M23-409
  • Ages 50-89
  • All Genders

Study Summary

ABBV-RGX-314 (also known as RGX-314) 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 Criteria

Inclusion

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 thestudy 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 atstudy entry

Exclusion

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 thestudy eye

  4. Active or history of retinal detachment, or current retinal tear that cannot betreated, in the study eye

  5. Advanced glaucoma or history of secondary glaucoma in the study eye

  6. Myocardial infarction, cerebrovascular accident, or transient ischemic attack withinthe past 6 months.

  7. History of intraocular surgery in the study eye within 12 weeks prior torandomization

  8. History of intravitreal therapy in the study eye, such as intravitreal steroidinjection or investigational product, other than anti-VEGF therapy, in the 6 monthsprior to Screening Visit 1.

  9. Prior treatment with gene therapy.

Study Design

Total Participants: 660
Treatment Group(s): 5
Primary Treatment: ABBV-RGX-314 Dose 2
Phase: 3
Study Start date:
December 28, 2021
Estimated Completion Date:
November 30, 2026

Study 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 660 participants who meet the inclusion/exclusion criteria, will be enrolled into one of 3 arms.

Connect with a study center

  • Calgary Retina Consultants

    Calgary, Alberta T2H 0C8
    Canada

    Active - Recruiting

  • Alberta Retina Consultants

    Edmonton, Alberta T5H 0X5
    Canada

    Active - Recruiting

  • Alberta Retina Research Corporation

    Edmonton, Alberta T5H 0X5
    Canada

    Active - Recruiting

  • University of British Columbia - Eye Care Centre, Vancouver General Hospital

    Vancouver, British Columbia V5Z 0A6
    Canada

    Active - Recruiting

  • Toronto Retina Institute

    North York, Ontario M3C 0G9
    Canada

    Active - Recruiting

  • Ottawa Hospital Research Institute

    Ottawa, Ontario K1H 8L6
    Canada

    Active - Recruiting

  • Retina Centre of Ottawa

    Ottawa, Ontario K2B 7E9
    Canada

    Active - Recruiting

  • Sunnybrook Health Sciences Centre

    Toronto, Ontario M4N 3M5
    Canada

    Active - Recruiting

  • CHU de Quebec-Universite Laval

    Québec, G1S 4L8
    Canada

    Site Not Available

  • CHU Nantes - Hopital Hotel Dieu Nantes

    Nantes, Loire-Atlantique 44093
    France

    Active - Recruiting

  • Clinique Honoré Cave

    Montauban, Midi-Pyrenees 82000
    France

    Active - Recruiting

  • Hopital de la Crois Rousse

    Lyon, Rhone 69004
    France

    Active - Recruiting

  • Centre Hospitalier Intercommunal de Creteil

    Créteil, Val-de-Marne 94000
    France

    Active - Recruiting

  • AP-HP - Groupe Hospitalier 10e - Hopital Lariboisiere

    Paris, 75010
    France

    Active - Recruiting

  • Hopitaux Universitaires Paris Centre-Hopital Cochin

    Paris, 75014
    France

    Active - Recruiting

  • University Medical Center Freiburg

    Freiburg Im Breisgau, Baden-Wurttemberg 79106
    Germany

    Active - Recruiting

  • Universitatsklinikum Bonn

    Bonn, Nordhein-Westfalen 53127
    Germany

    Active - Recruiting

  • Debreceni Egyetem Klinikai Kozpont

    Debrecen, Hajdu-Bihar 4032
    Hungary

    Active - Recruiting

  • Budapest Retina Intezet

    Budapest, 1133
    Hungary

    Active - Recruiting

  • Azienda Ospedaliero-Universitaria di Ferrara

    Cona, Ferrara 44124
    Italy

    Active - Recruiting

  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS

    Roma, Rom 00168
    Italy

    Active - Recruiting

  • IRCCS Fondazione G.B. Bietti

    Roma, 00918
    Italy

    Active - Recruiting

  • Kobe City Eye Hospital

    Kobe, Hyogo 650-0047
    Japan

    Active - Recruiting

  • Kagoshima University Hospital

    Kagoshima, 890-8520
    Japan

    Active - Recruiting

  • University of Miyazaki Hospital

    Miyazaki, 889-1692
    Japan

    Active - Recruiting

  • Juntendo University Hospital

    Tokyo, 113-8431
    Japan

    Active - Recruiting

  • Emanuelli Research and Development Center

    Arecibo, 00612
    Puerto Rico

    Active - Recruiting

  • Hospital Arruzafa

    Córdoba, Cordoba 14012
    Spain

    Active - Recruiting

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxfordshire OX3 9DU
    United Kingdom

    Active - Recruiting

  • Liverpool University Hospitals NHS Foundation Trust

    Liverpool, L7 8XP
    United Kingdom

    Active - Recruiting

  • Moorfields Eye Hospital NHS Foundation Trust

    London, EC1V 2PD
    United Kingdom

    Active - Recruiting

  • The Retina Clinic London

    London, W1G 7LB
    United Kingdom

    Active - Recruiting

  • Barnet Dulaney Perkins Eye Center

    Mesa, Arizona 85016
    United States

    Active - Recruiting

  • Retinal Consultants of Arizona

    Phoenix, Arizona 85014
    United States

    Active - Recruiting

  • Retinal Research Institute

    Phoenix, Arizona 85014
    United States

    Active - Recruiting

  • Retina Macula Institute of Arizona

    Scottsdale, Arizona 85255
    United States

    Active - Recruiting

  • California Retina Consultants

    Bakersfield, California 93309
    United States

    Active - Recruiting

  • Retina Vitreous Associates Medical Group

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Retinal Diagnostic Center

    Campbell, California 95008
    United States

    Active - Recruiting

  • Encino location

    Encino, California 91436
    United States

    Active - Recruiting

  • The Retina Partners

    Encino, California 91436
    United States

    Active - Recruiting

  • Retina Consultants of Orange County

    Fullerton, California 92835
    United States

    Active - Recruiting

  • Hamilton Glaucoma Center Shiley Eye Center UCSD

    La Jolla, California 92093
    United States

    Active - Recruiting

  • UC San Diego

    La Jolla, California 92093
    United States

    Active - Recruiting

  • Byers Eye Institute Stanford

    Palo Alto, California 94303
    United States

    Active - Recruiting

  • Retina Consultants of San Diego

    Poway, California 92064
    United States

    Active - Recruiting

  • Kaiser Permanente

    Riverside, California 92505
    United States

    Active - Recruiting

  • Retinal Consultants Medical Group, Inc

    Sacramento, California 85841
    United States

    Active - Recruiting

  • UC Davis

    Sacramento, California 95817
    United States

    Active - Recruiting

  • Orange County Retina Medical Group

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Santa Ana Location

    Santa Ana, California 92705
    United States

    Active - Recruiting

  • Macula Retina Vitreous Center - Torrance

    Torrance, California 90503
    United States

    Active - Recruiting

  • Bay Area Retina Associates

    Walnut Creek, California 94598
    United States

    Active - Recruiting

  • Colorado Springs location

    Colorado Springs, Colorado 80909
    United States

    Active - Recruiting

  • Retina Consultants of Southern Colorado P.C.

    Colorado Springs, Colorado 80909
    United States

    Active - Recruiting

  • Durango Location

    Durango, Colorado 81303
    United States

    Active - Recruiting

  • Southwest Retina Consultants

    Durango, Colorado 81303
    United States

    Active - Recruiting

  • Colorado Retina Associates

    Lakewood, Colorado 80228
    United States

    Active - Recruiting

  • Eye Care Center of Northern Colorado

    Longmont, Colorado 80503
    United States

    Active - Recruiting

  • Rand Eye Institute

    Deerfield Beach, Florida 33064
    United States

    Active - Recruiting

  • National Ophthalmic Research Institute

    Fort Myers, Florida 33912
    United States

    Active - Recruiting

  • Gainesville Location

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Vitreo Retinal Associates PA

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Vitreoretinal Associates, P.A.

    Gainesville, Florida 32607
    United States

    Active - Recruiting

  • Florida Retina Consultants

    Lakeland, Florida 33805
    United States

    Active - Recruiting

  • Florida Retina Institute

    Orlando, Florida 32806
    United States

    Active - Recruiting

  • Retina Specialty Institute

    Pensacola, Florida 32503
    United States

    Active - Recruiting

  • Fort Lauderdale Eye Institute

    Plantation, Florida 33324
    United States

    Active - Recruiting

  • Rand Eye Institute

    Pompano Beach, Florida 33064
    United States

    Site Not Available

  • Retina Vitreous Associates of Florida - Saint Petersburg

    Saint Petersburg, Florida 33711
    United States

    Site Not Available

  • Center for Retina and Macular Disease

    Winter Haven, Florida 33880
    United States

    Active - Recruiting

  • Georgia Retina PC

    Marietta, Georgia 30060
    United States

    Active - Recruiting

  • 'Aiea location

    'Aiea, Hawaii 96701
    United States

    Active - Recruiting

  • Retina Consultants of Hawaii

    'Aiea, Hawaii 96701
    United States

    Active - Recruiting

  • Northwestern Medicine Fertility and Reproductive Medicine

    Chicago, Illinois 60611
    United States

    Active - Recruiting

  • Lemont location

    Lemont, Illinois 60439
    United States

    Active - Recruiting

  • University Retina and Macula Associates, P.C.

    Lemont, Illinois 60439
    United States

    Active - Recruiting

  • Oak Forest location

    Oak Forest, Illinois 60452
    United States

    Active - Recruiting

  • University Retina and Macula Associates, P.C.

    Oak Forest, Illinois 60452
    United States

    Site Not Available

  • Illinois Retina Associates

    Oak Park, Illinois 60304
    United States

    Active - Recruiting

  • Springfield Clinic

    Springfield, Illinois 62702
    United States

    Active - Recruiting

  • Retina Partners Midwest, PC

    Carmel, Indiana 46290
    United States

    Active - Recruiting

  • MidWest Eye Institute

    Indianapolis, Indiana 46290
    United States

    Site Not Available

  • John-Kenyon American Eye Institute

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • New Albany Location

    New Albany, Indiana 47150
    United States

    Active - Recruiting

  • Wolfe Eye Clinic

    West Des Moines, Iowa 50266
    United States

    Active - Recruiting

  • Retina Associates, LLC

    Lenexa, Kansas 66215
    United States

    Active - Recruiting

  • Maine Eye Center

    Portland, Maine 04101
    United States

    Active - Recruiting

  • Greater Baltimore Medical Ctr

    Baltimore, Maryland 21204
    United States

    Active - Recruiting

  • Johns Hopkins Hospital

    Baltimore, Maryland 21287-7277
    United States

    Active - Recruiting

  • Johns Hopkins University

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Retina Specialists

    Baltimore, Maryland 21204
    United States

    Active - Recruiting

  • Wilmer Eye Institute

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Mid Atlantic Reina Specialists

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Mid Atlantic Retina Specialists

    Hagerstown, Maryland 21740
    United States

    Active - Recruiting

  • Boston Location

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Massachusetts Eye and Ear Infirmary

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Ophthalmic Consultants of Boston, Inc

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Retina Associates of Michigan

    Grand Blanc, Michigan 48439
    United States

    Active - Recruiting

  • Associated Retinal Consultants

    Novi, Michigan 48375
    United States

    Site Not Available

  • Novi Location

    Novi, Michigan 48375
    United States

    Active - Recruiting

  • Associated Retinal Consultants

    Royal Oak, Michigan 48375
    United States

    Active - Recruiting

  • Edina Location

    Edina, Minnesota 55435
    United States

    Active - Recruiting

  • Vitreo Retinal Surgery, PA

    Edina, Minnesota 55435
    United States

    Site Not Available

  • VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota

    Minneapolis, Minnesota 55435
    United States

    Active - Recruiting

  • Mayo Clinic

    Rochester, Minnesota 55905
    United States

    Active - Recruiting

  • Mississippi Retina Associates

    Jackson, Mississippi 39202
    United States

    Active - Recruiting

  • Midwest Vision Research Foundation

    Chesterfield, Missouri 63017
    United States

    Active - Recruiting

  • University of Missouri - Mason Eye Institute

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • Washington University Ophthalmology

    Saint Louis, Missouri 63108
    United States

    Active - Recruiting

  • Sierra Eye Associates

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Envision Ocular, LLC

    Bloomfield, New Jersey 07003
    United States

    Active - Recruiting

  • Columbia University Irving Medical Center - Harness Eye Institute

    New York, New York 10032
    United States

    Active - Recruiting

  • Retina Associates of Western New York

    Rochester, New York 14620
    United States

    Site Not Available

  • Western Carolina Retina Associates P.A.

    Asheville, North Carolina 28803
    United States

    Active - Recruiting

  • Duke Eye Center

    Durham, North Carolina 27705
    United States

    Active - Recruiting

  • Graystone Eye

    Hickory, North Carolina 28602
    United States

    Active - Recruiting

  • Greystone Eye

    Hickory, North Carolina 28602
    United States

    Active - Recruiting

  • Cincinnati Eye Institute

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Cincinnati Location

    Cincinnati, Ohio 45242
    United States

    Active - Recruiting

  • Cleveland Clinic

    Cleveland, Ohio 44195
    United States

    Active - Recruiting

  • Retina Associates of Cleveland

    Cleveland, Ohio 44130
    United States

    Active - Recruiting

  • Retina Associates of Cleveland, Inc.

    Cleveland, Ohio 44130
    United States

    Active - Recruiting

  • The Ohio State University Eye & Ear Institute

    Columbus, Ohio 43212
    United States

    Active - Recruiting

  • Edmond Location

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Retina Vitreous Center Research

    Edmond, Oklahoma 73013
    United States

    Active - Recruiting

  • Mid Atlantic Retina

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Scheie Eye Institute

    Philadelphia, Pennsylvania 19104
    United States

    Active - Recruiting

  • University of Pennsylvania

    Philadelphia, Pennsylvania 19104-2640
    United States

    Active - Recruiting

  • UPMC Vision Institute

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • University of Pittsburgh Medical Center

    Pittsburgh, Pennsylvania 15213
    United States

    Active - Recruiting

  • Charleston Neuroscience Institute - Beaufort

    Beaufort, South Carolina 29902
    United States

    Active - Recruiting

  • Retina Consultants of Charleston

    Beaufort, South Carolina 29902
    United States

    Active - Recruiting

  • Charleston Neurosciences Institute

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Retina Consulants of Charleston

    Charleston, South Carolina 29414
    United States

    Active - Recruiting

  • Palmetto Retina Center LLC

    Florence, South Carolina 29501
    United States

    Site Not Available

  • Charleston Neurosciences Institute

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • Retina Consultants of Charleston

    Ladson, South Carolina 29456
    United States

    Active - Recruiting

  • Black Hills Regional Eye Institute

    Rapid City, South Dakota 57701
    United States

    Active - Recruiting

  • Southeastern Retina Associates

    Chattanooga, Tennessee 37421
    United States

    Active - Recruiting

  • Charles Retina Institute

    Germantown, Tennessee 38138
    United States

    Active - Recruiting

  • Southeastern Retina Associates

    Johnson City, Tennessee 37604
    United States

    Active - Recruiting

  • Memphis Location

    Memphis, Tennessee 38138
    United States

    Site Not Available

  • Tennessee Retina Center Murfreesboro

    Nashville, Tennessee 37203
    United States

    Active - Recruiting

  • Vanderbilt University Medical Center

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • Retina Research Institute of Texas

    Abilene, Texas 79606-1224
    United States

    Active - Recruiting

  • West Texas Retina Consultants - Abilene

    Abilene, Texas 79606
    United States

    Active - Recruiting

  • Texas Retina Associates

    Arlington, Texas 76012
    United States

    Site Not Available

  • Austin Clinical Research, LLC

    Austin, Texas 78750
    United States

    Active - Recruiting

  • Austin Research Center for Retina

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Retina Consultants of Austin

    Austin, Texas 78705
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    Bellaire, Texas 77401
    United States

    Active - Recruiting

  • Star Retina

    Burleson, Texas 76028
    United States

    Active - Recruiting

  • Ophthalmology Surgery Center of Dallas

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Texas Retina Associates

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Texas Retina Associates

    Fort Worth, Texas 76012
    United States

    Active - Recruiting

  • Austin Retina Associates

    Round Rock, Texas 78681
    United States

    Active - Recruiting

  • Brown Retina Institute

    San Antonio, Texas 78251
    United States

    Active - Recruiting

  • RCTX - San Antonio Retina Center

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Associates of South Texas, P.A.

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Consultants of Texas

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Stone Oak Surgery Center

    San Antonio, Texas 78240
    United States

    Active - Recruiting

  • Retina Center of Texas - Southlake

    Southlake, Texas 76092
    United States

    Active - Recruiting

  • Retina Associates of Utah

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Rocky Mountain Retina Consultants

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Salt Lake City Location

    Salt Lake City, Utah 84107
    United States

    Active - Recruiting

  • Piedmont Eye Center

    Lynchburg, Virginia 24502
    United States

    Active - Recruiting

  • Norfolk location

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Wagner Macula & Retina Center

    Norfolk, Virginia 23502
    United States

    Active - Recruiting

  • Retina Institute of Virginia

    Richmond, Virginia 23235
    United States

    Site Not Available

  • Vistar Eye Center

    Salem, Virginia 21153
    United States

    Active - Recruiting

  • Pacific Northwest Retina

    Bellevue, Washington 98004
    United States

    Active - Recruiting

  • Vitreoretinal Associates of Washington

    Bellevue, Washington 98004
    United States

    Active - Recruiting

  • Retina Center NW, PLLC

    Silverdale, Washington 98383
    United States

    Active - Recruiting

  • Retina Center Northwest

    Silverdale, Washington 98383
    United States

    Active - Recruiting

  • Spokane Eye Clinical Research

    Spokane, Washington 99204
    United States

    Active - Recruiting

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