RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2021-12-28
Study Completion:2026-11
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT05407636

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.

Ages Eligible for Study:50 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 1. Age ≥ 50 years and ≤ 89 years
  2. 2. An ETDRS BCVA letter score between ≤ 78 and ≥ 40 in the study eye
  3. 3. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in the study eye previously treated with anti-VEGF
  4. 4. Must be pseudophakic (at least 12 weeks postcataract surgery) in the study eye
  5. 5. Willing and able to provide written, signed informed consent for this study
  6. 6. Participants must have demonstrated a meaningful response to anti-VEGF therapy at study entry
  1. 1. CNV or macular edema in the study eye secondary to any causes other than AMD
  2. 2. Subfoveal fibrosis or atrophy in the study eye
  3. 3. Any condition in the investigator's opinion that could limit VA improvement in the study eye
  4. 4. Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye
  5. 5. Advanced glaucoma or history of secondary glaucoma in the study eye
  6. 6. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months.
  7. 7. History of intraocular surgery in the study eye within 12 weeks prior to randomization
  8. 8. History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1.
  9. 9. Prior treatment with gene therapy.

Contacts and Locations

Study Contact

Patient Advocacy
CONTACT
+(1) 833-711-0349
Patientadvocacy@regenxbio.com

Study Locations (Sites)

Barnet Dulaney Perkins Eye Center
Mesa, Arizona, 85016
United States
Retinal Research Institute
Phoenix, Arizona, 85014
United States
Retina Macula Institute of Arizona
Scottsdale, Arizona, 85255
United States
California Retina Consultants
Bakersfield, California, 93309
United States
Retina Vitreous Associates Medical Group
Beverly Hills, California, 90211
United States
Retinal Diagnostic Center
Campbell, California, 95008
United States
The Retina Partners
Encino, California, 91436
United States
Retina Consultants of Orange County
Fullerton, California, 92835
United States
Hamilton Glaucoma Center Shiley Eye Center UCSD
La Jolla, California, 92093
United States
Byers Eye Institute Stanford
Palo Alto, California, 94303
United States
Retina Consultants of San Diego
Poway, California, 92064
United States
Kaiser Permanente
Riverside, California, 92505
United States
Retinal Consultants Medical Group, Inc
Sacramento, California, 85841
United States
UC Davis
Sacramento, California, 95817
United States
Orange County Retina Medical Group
Santa Ana, California, 92705
United States
Macula Retina Vitreous Center - Torrance
Torrance, California, 90503
United States
Bay Area Retina Associates
Walnut Creek, California, 94598
United States
Retina Consultants of Southern Colorado P.C.
Colorado Springs, Colorado, 80909
United States
Southwest Retina Consultants
Durango, Colorado, 81303
United States
Colorado Retina Associates
Lakewood, Colorado, 80228
United States
Eye Care Center of Northern Colorado
Longmont, Colorado, 80503
United States
Rand Eye Institute
Deerfield Beach, Florida, 33064
United States
National Ophthalmic Research Institute
Fort Myers, Florida, 33912
United States
Vitreo Retinal Associates PA
Gainesville, Florida, 32607
United States
Vitreoretinal Associates, P.A.
Gainesville, Florida, 32607
United States
Florida Retina Consultants
Lakeland, Florida, 33805
United States
Florida Retina Institute
Orlando, Florida, 32806
United States
Retina Specialty Institute
Pensacola, Florida, 32503
United States
Fort Lauderdale Eye Institute
Plantation, Florida, 33324
United States
Center for Retina and Macular Disease
Winter Haven, Florida, 33880
United States
Georgia Retina PC
Marietta, Georgia, 30060
United States
Retina Consultants of Hawaii
'Aiea, Hawaii, 96701
United States
Northwestern Medicine Fertility and Reproductive Medicine
Chicago, Illinois, 60611
United States
University Retina and Macula Associates, P.C.
Lemont, Illinois, 60439
United States
Illinois Retina Associates
Oak Park, Illinois, 60304
United States
Springfield Clinic
Springfield, Illinois, 62702
United States
Retina Partners Midwest, PC
Carmel, Indiana, 46290
United States
John-Kenyon American Eye Institute
New Albany, Indiana, 47150
United States
Wolfe Eye Clinic
West Des Moines, Iowa, 50266
United States
Retina Associates, LLC
Lenexa, Kansas, 66215
United States
Maine Eye Center
Portland, Maine, 04101
United States
Greater Baltimore Medical Ctr
Baltimore, Maryland, 21204
United States
Johns Hopkins Hospital
Baltimore, Maryland, 21287-7277
United States
Mid Atlantic Retina Specialists
Hagerstown, Maryland, 21740
United States
Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114
United States
Ophthalmic Consultants of Boston, Inc
Boston, Massachusetts, 02114
United States
Retina Associates of Michigan
Grand Blanc, Michigan, 48439
United States
Associated Retinal Consultants
Royal Oak, Michigan, 48375
United States
VitreoRetinal Surgery PLLC DBA Retina Consultants of Minnesota
Minneapolis, Minnesota, 55435
United States
Mayo Clinic
Rochester, Minnesota, 55905
United States
Mississippi Retina Associates
Jackson, Mississippi, 39202
United States
Midwest Vision Research Foundation
Chesterfield, Missouri, 63017
United States
University of Missouri - Mason Eye Institute
Columbia, Missouri, 65212
United States
Washington University Ophthalmology
Saint Louis, Missouri, 63108
United States
Sierra Eye Associates
Reno, Nevada, 89502
United States
Envision Ocular, LLC
Bloomfield, New Jersey, 07003
United States
Columbia University Irving Medical Center - Harness Eye Institute
New York, New York, 10032
United States
Retina Associates of Western New York
Rochester, New York, 14620
United States
Western Carolina Retina Associates P.A.
Asheville, North Carolina, 28803
United States
Duke Eye Center
Durham, North Carolina, 27705
United States
Graystone Eye
Hickory, North Carolina, 28602
United States
Cincinnati Eye Institute
Cincinnati, Ohio, 45242
United States
Retina Associates of Cleveland
Cleveland, Ohio, 44130
United States
Cleveland Clinic
Cleveland, Ohio, 44195
United States
The Ohio State University Eye & Ear Institute
Columbus, Ohio, 43212
United States
Retina Vitreous Center Research
Edmond, Oklahoma, 73013
United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104-2640
United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107
United States
UPMC Vision Institute
Pittsburgh, Pennsylvania, 15213
United States
Charleston Neuroscience Institute - Beaufort
Beaufort, South Carolina, 29902
United States
Charleston Neurosciences Institute
Charleston, South Carolina, 29414
United States
Charleston Neurosciences Institute
Ladson, South Carolina, 29456
United States
Black Hills Regional Eye Institute
Rapid City, South Dakota, 57701
United States
Southeastern Retina Associates
Chattanooga, Tennessee, 37421
United States
Charles Retina Institute
Germantown, Tennessee, 38138
United States
Southeastern Retina Associates
Johnson City, Tennessee, 37604
United States
Tennessee Retina Center Murfreesboro
Nashville, Tennessee, 37203
United States
Vanderbilt University Medical Center
Nashville, Tennessee, 37232
United States
Retina Research Institute of Texas
Abilene, Texas, 79606-1224
United States
Austin Research Center for Retina
Austin, Texas, 78705
United States
Austin Clinical Research, LLC
Austin, Texas, 78750
United States
Retina Consultants of Texas
Bellaire, Texas, 77401
United States
Star Retina
Burleson, Texas, 76028
United States
Ophthalmology Surgery Center of Dallas
Dallas, Texas, 75231
United States
Texas Retina Associates
Fort Worth, Texas, 76012
United States
Austin Retina Associates
Round Rock, Texas, 78681
United States
RCTX - San Antonio Retina Center
San Antonio, Texas, 78240
United States
Stone Oak Surgery Center
San Antonio, Texas, 78240
United States
Retina Center of Texas - Southlake
Southlake, Texas, 76092
United States
Retina Associates of Utah
Salt Lake City, Utah, 84107
United States
Rocky Mountain Retina Consultants
Salt Lake City, Utah, 84107
United States
Piedmont Eye Center
Lynchburg, Virginia, 24502
United States
Wagner Macula & Retina Center
Norfolk, Virginia, 23502
United States
Vistar Eye Center
Salem, Virginia, 21153
United States
Pacific Northwest Retina
Bellevue, Washington, 98004
United States
Retina Center NW, PLLC
Silverdale, Washington, 98383
United States
Spokane Eye Clinical Research
Spokane, Washington, 99204
United States

Collaborators and Investigators

Sponsor: AbbVie

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 Registration Dates

Study Start Date2021-12-28
Study Completion Date2026-11

Study Record Updates

Study Start Date2021-12-28
Study Completion Date2026-11

Terms related to this study

Keywords Provided by Researchers

  • Age-Related Macular Degeneration
  • Neovascular Age-Related Macular Degeneration
  • Macular Degeneration
  • Wet Macular Degeneration
  • Choroidal Neovascularization
  • Retinal Degeneration
  • Retinal Diseases
  • Eye Diseases
  • Ranibizumab
  • Aflibercept
  • Angiogenesis Inhibitors
  • Angiogenesis Modulating Agents
  • Growth Substances
  • Physiological Effects of Drugs
  • Growth Inhibitors
  • Antineoplastic Agents
  • Gene Therapy
  • Anti-vascular endothelial grown factory therapy
  • Anti-VEGF therapy

Additional Relevant MeSH Terms

  • AMD
  • nAMD
  • Wet Age-related Macular Degeneration
  • wAMD
  • WetAMD
  • CNV