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Search / Trial NCT04704921

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 01, 2025

Recruiting

Keywords

Age Related Macular Degeneration Neovascular Age Related Macular Degeneration Macular Degeneration Wet Macular Degeneration Choroidal Neovascularization Retinal Degeneration Retinal Diseases Eye Diseases Ranibizumab 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

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.

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

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

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