Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD
Launched by ABBVIE · Jan 8, 2021
Trial Information
Current as of July 24, 2025
Recruiting
Keywords
ClinConnect Summary
The Pivotal 1 Study is testing a new one-time gene therapy called RGX-314 for people with wet age-related macular degeneration (wet AMD). This condition causes vision loss due to the growth of new, leaky blood vessels in the eye. Currently, patients often need regular injections every few weeks to manage their condition, which can be burdensome and lead to vision decline if treatments are missed. RGX-314 aims to provide a simpler, long-lasting solution for wet AMD by potentially reducing the need for ongoing treatments.
To be eligible for this study, participants must be between 50 and 89 years old and have previously received treatment for their wet AMD with a specific type of medication called anti-VEGF. They should also have a certain level of vision measured by a specific test and must have had cataract surgery at least 12 weeks prior. Participants will receive the RGX-314 treatment and will be closely monitored throughout the study to assess its effectiveness. If you or someone you know is interested, it's a chance to be part of research that could change how wet AMD is treated in the future.
Gender
ALL
Eligibility criteria
- 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 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
- 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, as determined by CRC
- • 3. Any condition in the investigator's opinion that could limit VA improvement in the study eye
- • 4. Active or history of retinal detachment, or current retinal tear that cannot be treated, in the study eye
- • 5. Advanced glaucoma or history of secondary glaucoma in the study eye
- • 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 product, other than anti-VEGF therapy, in the 6 months prior to Screening Visit 1
- • 8. Prior treatment with gene therapy
- • 9. Recent myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
About Abbvie
AbbVie is a global biopharmaceutical company dedicated to developing innovative therapies that address complex health challenges. Founded in 2013 as a spin-off from Abbott Laboratories, AbbVie focuses on key therapeutic areas, including immunology, oncology, neuroscience, and virology. The company is committed to advancing scientific research and delivering groundbreaking treatments that enhance patient outcomes and quality of life. With a robust pipeline and a strong emphasis on collaboration, AbbVie strives to transform the future of medicine through its commitment to clinical excellence and patient-centered approaches.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Dallas, Texas, United States
Cleveland, Ohio, United States
Winston Salem, North Carolina, United States
Beverly Hills, California, United States
Austin, Texas, United States
Poway, California, United States
Rapid City, South Dakota, United States
Rochester, Minnesota, United States
Springfield, Illinois, United States
Augusta, Georgia, United States
Springfield, Illinois, United States
Santa Ana, California, United States
Campbell, California, United States
Indianapolis, Indiana, United States
Reno, Nevada, United States
Germantown, Tennessee, United States
Austin, Texas, United States
Portland, Oregon, United States
Boston, Massachusetts, United States
Reno, Nevada, United States
Royal Oak, Michigan, United States
Virginia Beach, Virginia, United States
Pasadena, California, United States
Austin, Texas, United States
Austin, Texas, United States
Gainesville, Florida, United States
Phoenix, Arizona, United States
Beverly Hills, California, United States
Mountain View, California, United States
Poway, California, United States
Augusta, Georgia, United States
Albuquerque, New Mexico, United States
Philadelphia, Pennsylvania, United States
Germantown, Tennessee, United States
Campbell, California, United States
Pasadena, California, United States
Oak Forest, Illinois, United States
Hagerstown, Maryland, United States
Durham, North Carolina, United States
Sun City, Arizona, United States
Encino, California, United States
Fullerton, California, United States
Irvine, California, United States
Los Angeles, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Santa Barbara, California, United States
Colorado Springs, Colorado, United States
Durango, Colorado, United States
Lakewood, Colorado, United States
Waterford, Connecticut, United States
Gainesville, Florida, United States
Miami, Florida, United States
Pensacola, Florida, United States
Saint Petersburg, Florida, United States
Tallahassee, Florida, United States
Marietta, Georgia, United States
'Aiea, Hawaii, United States
Chicago, Illinois, United States
Lemont, Illinois, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
Shawnee Mission, Kansas, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Royal Oak, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Great Neck, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Edmond, Oklahoma, United States
Portland, Oregon, United States
Rapid City, South Dakota, United States
Abilene, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Burleson, Texas, United States
Dallas, Texas, United States
Southlake, Texas, United States
The Woodlands, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Virginia Beach, Virginia, United States
Madison, Wisconsin, United States
Phoenix, Arizona, United States
Sun City, Arizona, United States
Encino, California, United States
Fullerton, California, United States
Irvine, California, United States
Los Angeles, California, United States
Mountain View, California, United States
Pasadena, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Francisco, California, United States
Santa Barbara, California, United States
Colorado Springs, Colorado, United States
Durango, Colorado, United States
Lakewood, Colorado, United States
Waterford, Connecticut, United States
Gainesville, Florida, United States
Miami, Florida, United States
Pensacola, Florida, United States
Saint Petersburg, Florida, United States
Tallahassee, Florida, United States
Marietta, Georgia, United States
'Aiea, Hawaii, United States
Chicago, Illinois, United States
Lemont, Illinois, United States
Oak Forest, Illinois, United States
New Albany, Indiana, United States
Shawnee Mission, Kansas, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Hagerstown, Maryland, United States
Boston, Massachusetts, United States
Minneapolis, Minnesota, United States
Albuquerque, New Mexico, United States
Great Neck, New York, United States
Durham, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Edmond, Oklahoma, United States
Erie, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Abilene, Texas, United States
Burleson, Texas, United States
Southlake, Texas, United States
The Woodlands, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Bellevue, Washington, United States
Silverdale, Washington, United States
Madison, Wisconsin, United States
Lakeland, Florida, United States
Grand Blanc, Michigan, United States
Ladson, South Carolina, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Beverly Hills, California, United States
Phoenix, Arizona, United States
Sun City, Arizona, United States
Little Rock, Arkansas, United States
Beverly Hills, California, United States
Campbell, California, United States
Encino, California, United States
Fullerton, California, United States
Huntington Beach, California, United States
Irvine, California, United States
Los Angeles, California, United States
Mountain View, California, United States
Pasadena, California, United States
Poway, California, United States
Sacramento, California, United States
San Francisco, California, United States
San Francisco, California, United States
Santa Ana, California, United States
Santa Barbara, California, United States
Colorado Springs, Colorado, United States
Durango, Colorado, United States
Lakewood, Colorado, United States
Waterford, Connecticut, United States
Deerfield Beach, Florida, United States
Gainesville, Florida, United States
Lakeland, Florida, United States
Miami, Florida, United States
Pensacola, Florida, United States
Saint Petersburg, Florida, United States
Tallahassee, Florida, United States
Augusta, Georgia, United States
Marietta, Georgia, United States
Marietta, Georgia, United States
Sandy Springs, Georgia, United States
'Aiea, Hawaii, United States
Chicago, Illinois, United States
Lemont, Illinois, United States
Oak Forest, Illinois, United States
Springfield, Illinois, United States
Indianapolis, Indiana, United States
New Albany, Indiana, United States
Lenexa, Kansas, United States
Metairie, Louisiana, United States
New Orleans, Louisiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Chevy Chase, Maryland, United States
Hagerstown, Maryland, United States
Boston, Massachusetts, United States
Grand Blanc, Michigan, United States
Royal Oak, Michigan, United States
Minneapolis, Minnesota, United States
Rochester, Minnesota, United States
Saint Louis, Missouri, United States
Reno, Nevada, United States
Albuquerque, New Mexico, United States
Great Neck, New York, United States
Liverpool, New York, United States
Durham, North Carolina, United States
Winston Salem, North Carolina, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Edmond, Oklahoma, United States
Eugene, Oregon, United States
Portland, Oregon, United States
Erie, Pennsylvania, United States
Monroeville, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Ladson, South Carolina, United States
Rapid City, South Dakota, United States
Germantown, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Beaumont, Texas, United States
Bellaire, Texas, United States
Burleson, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Southlake, Texas, United States
The Woodlands, Texas, United States
Salt Lake City, Utah, United States
Salt Lake City, Utah, United States
Norfolk, Virginia, United States
Bellevue, Washington, United States
Silverdale, Washington, United States
Madison, Wisconsin, United States
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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