Pivotal 2 Study of RGX-314 Gene Therapy in Participants With nAMD
Launched by ABBVIE · Jun 2, 2022
Trial Information
Current as of August 20, 2025
Recruiting
Keywords
ClinConnect Summary
The Pivotal 2 Study is investigating a new gene therapy called ABBV-RGX-314 for people with wet age-related macular degeneration (wet AMD). This condition causes vision loss due to the growth of abnormal, leaky blood vessels in the eye. Currently, patients receive frequent injections every few months to help maintain their vision, which can be burdensome. This trial aims to see if a one-time treatment with RGX-314 can effectively improve or maintain vision in patients affected by wet AMD.
To participate in the study, individuals must be between 50 and 89 years old and have already shown some improvement from previous anti-VEGF treatments. They should also have had cataract surgery at least 12 weeks prior. Participants will receive the gene therapy and will be monitored to see how well it works. This study is currently recruiting participants, and anyone interested should discuss the potential benefits and risks with their healthcare provider.
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 choroidal neovascularization (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
- Inclusion Criteria (Bilateral Treatment Substudy)\*:
- • 1. An ETDRS BCVA letter score between ≤ 83 and ≥ 40 in both eyes
- • 2. Diagnosis of subfoveal choroidal neovascularization (CNV) secondary to AMD in both eyes
- • 3. Must be pseudophakic (at least 12 weeks postcataract surgery) in both eyes
- • 4. Willing and able to provide written, signed informed consent for this study
- • 5. Newcomers must have active disease in the study eye; crossover participants must have active disease in the eye not treated in the main study
- 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 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. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
- • 7. History of intraocular surgery in the study eye within 12 weeks prior to randomization
- • 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. Prior treatment with gene therapy
- Exclusion Criteria (Bilateral Treatment Substudy)\*:
- • 1. CNV or macular edema in either eye secondary to any causes other than AMD
- • 2. Subfoveal fibrosis or atrophy in either eye
- • 3. Any condition in the investigator's opinion that could limit VA improvement in either eye
- • 4. Active or history of retinal detachment, or current retinal tear that cannot be treated in either eye
- • 5. Advanced glaucoma or history of secondary glaucoma in either eye
- • 6. Myocardial infarction, cerebrovascular accident, or transient ischemic attack within the past 6 months
- • 7. History of intraocular surgery in either eye within 12 weeks prior to randomization
- • 8. History of intravitreal therapy in either eye, such as intravitreal steroid injection or investigational product, other than anti-VEGF therapy, in the 6 months prior to screening
- • 9. Prior treatment with gene therapy (\*) For previously treated crossover participants, criteria apply to the eye not treated in the main study only.
- • Note: Other inclusion/exclusion criteria apply
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
Rochester, Minnesota, United States
Philadelphia, Pennsylvania, United States
Dallas, Texas, United States
Philadelphia, Pennsylvania, United States
Baltimore, Maryland, United States
Boston, Massachusetts, United States
Pittsburgh, Pennsylvania, United States
Cleveland, Ohio, United States
Nashville, Tennessee, United States
Toronto, Ontario, Canada
Salt Lake City, Utah, United States
Ottawa, Ontario, Canada
Sacramento, California, United States
Baltimore, Maryland, United States
Fort Myers, Florida, United States
Winter Haven, Florida, United States
Rapid City, South Dakota, United States
Beverly Hills, California, United States
Baltimore, Maryland, United States
Cincinnati, Ohio, United States
Walnut Creek, California, United States
Arlington, Texas, United States
Silverdale, Washington, United States
Springfield, Illinois, United States
Santa Ana, California, United States
Lakeland, Florida, United States
New Albany, Indiana, United States
Phoenix, Arizona, United States
Bakersfield, California, United States
Campbell, California, United States
London, , United Kingdom
Tokyo, , Japan
Oak Park, Illinois, United States
Indianapolis, Indiana, United States
Edmonton, Alberta, Canada
West Des Moines, Iowa, United States
Spokane, Washington, United States
La Jolla, California, United States
Philadelphia, Pennsylvania, United States
Pensacola, Florida, United States
Plantation, Florida, United States
Cleveland, Ohio, United States
Encino, California, United States
Reno, Nevada, United States
Richmond, Virginia, United States
Fullerton, California, United States
Poway, California, United States
Rochester, New York, United States
'Aiea, Hawaii, United States
Chattanooga, Tennessee, United States
Calgary, Alberta, Canada
Durham, North Carolina, United States
Oak Forest, Illinois, United States
Salt Lake City, Utah, United States
Marietta, Georgia, United States
Portland, Maine, United States
Chesterfield, Missouri, United States
Bellevue, Washington, United States
Lynchburg, Virginia, United States
Oxford, Oxfordshire, United Kingdom
Longmont, Colorado, United States
Saint Petersburg, Florida, United States
Phoenix, Arizona, United States
Germantown, Tennessee, United States
Phoenix, Arizona, United States
Bellaire, Texas, United States
Norfolk, Virginia, United States
Cleveland, Ohio, United States
Kagoshima, , Japan
Orlando, Florida, United States
Hagerstown, Maryland, United States
Austin, Texas, United States
Abilene, Texas, United States
Boston, Massachusetts, United States
Debrecen, Hajdu Bihar, Hungary
Deerfield Beach, Florida, United States
Créteil, , France
Miyazaki, , Japan
Hickory, North Carolina, United States
Arecibo, , Puerto Rico
San Antonio, Texas, United States
Saint Louis, Missouri, United States
Bloomfield, New Jersey, United States
Durango, Colorado, United States
Riverside, California, United States
Pompano Beach, Florida, United States
Cleveland, Ohio, United States
Lakewood, Colorado, United States
Austin, Texas, United States
North York, Ontario, Canada
Austin, Texas, United States
Fort Worth, Texas, United States
Budapest, , Hungary
Gainesville, Florida, United States
Silverdale, Washington, United States
Liverpool, Merseyside, United Kingdom
San Antonio, Texas, United States
Oak Forest, Illinois, United States
Encino, California, United States
Santa Ana, California, United States
Colorado Springs, Colorado, United States
Gainesville, Florida, United States
Lemont, Illinois, United States
New Albany, Indiana, United States
Cincinnati, Ohio, United States
Edmond, Oklahoma, United States
Salt Lake City, Utah, United States
Ottawa, Ontario, Canada
Bellevue, Washington, United States
Chicago, Illinois, United States
Durango, Colorado, United States
'Aiea, Hawaii, United States
Novi, Michigan, United States
Edina, Minnesota, United States
Memphis, Tennessee, United States
Norfolk, Virginia, United States
Grand Blanc, Michigan, United States
San Antonio, Texas, United States
Jackson, Mississippi, United States
Southlake, Texas, United States
Round Rock, Texas, United States
Lenexa, Kansas, United States
Mesa, Arizona, United States
Sacramento, California, United States
Colorado Springs, Colorado, United States
Gainesville, Florida, United States
Lemont, Illinois, United States
Hagerstown, Maryland, United States
Boston, Massachusetts, United States
Novi, Michigan, United States
Edina, Minnesota, United States
New York, New York, United States
Asheville, North Carolina, United States
Hickory, North Carolina, United States
Columbus, Ohio, United States
Edmond, Oklahoma, United States
Beaufort, South Carolina, United States
Charleston, South Carolina, United States
Florence, South Carolina, United States
Ladson, South Carolina, United States
Johnson City, Tennessee, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Burleson, Texas, United States
Edmonton, Alberta, Canada
Québec, , Canada
Dallas, Texas, United States
London, , United Kingdom
Paris, , France
Scottsdale, Arizona, United States
La Jolla, California, United States
Palo Alto, California, United States
Torrance, California, United States
Carmel, Indiana, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Royal Oak, Michigan, United States
Minneapolis, Minnesota, United States
Columbia, Missouri, United States
Pittsburgh, Pennsylvania, United States
Beaufort, South Carolina, United States
Charleston, South Carolina, United States
Ladson, South Carolina, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Salem, Virginia, United States
Vancouver, British Columbia, Canada
Nantes, Loire Atlantique, France
Montauban, Midi Pyrenees, France
Lyon, Rhone, France
Créteil, Val De Marne, France
Paris, , France
Freiburg Im Breisgau, Baden Wurttemberg, Germany
Bonn, Nordhein Westfalen, Germany
Cona, Ferrara, Italy
Roma, Rom, Italy
Roma, , Italy
Kobe, Hyogo, Japan
Córdoba, Cordoba, Spain
Québec, Quebec, Canada
Phoenix, Arizona, United States
Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Bakersfield, California, United States
Beverly Hills, California, United States
Campbell, California, United States
Encino, California, United States
Fullerton, California, United States
La Jolla, California, United States
Oxnard, California, United States
Palo Alto, California, United States
Poway, California, United States
Riverside, California, United States
Sacramento, California, United States
Sacramento, California, United States
Santa Ana, California, United States
Torrance, California, United States
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Durango, Colorado, United States
Lakewood, Colorado, United States
Longmont, Colorado, United States
Manchester, Connecticut, United States
Deerfield Beach, Florida, United States
Fort Myers, Florida, United States
Gainesville, Florida, United States
Lakeland, Florida, United States
Orlando, Florida, United States
Pensacola, Florida, United States
Plantation, Florida, United States
Saint Petersburg, Florida, United States
Winter Haven, Florida, United States
Marietta, Georgia, United States
'Aiea, Hawaii, United States
Chicago, Illinois, 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
West Des Moines, Iowa, United States
Lenexa, Kansas, United States
Portland, Maine, United States
Baltimore, Maryland, United States
Baltimore, Maryland, United States
Hagerstown, Maryland, United States
Boston, Massachusetts, United States
Boston, Massachusetts, United States
Worcester, Massachusetts, United States
Grand Blanc, Michigan, United States
Royal Oak, Michigan, United States
Edina, Minnesota, United States
Rochester, Minnesota, United States
Madison, Mississippi, United States
Chesterfield, Missouri, United States
Columbia, Missouri, United States
Saint Louis, Missouri, United States
Reno, Nevada, United States
Bloomfield, New Jersey, United States
Little Silver, New Jersey, United States
New York, New York, United States
Rochester, New York, United States
Asheville, North Carolina, United States
Durham, North Carolina, United States
Hickory, North Carolina, United States
Blue Ash, Ohio, United States
Cleveland, Ohio, United States
Cleveland, Ohio, United States
Columbus, Ohio, United States
Dublin, Ohio, United States
Edmond, Oklahoma, United States
Philadelphia, Pennsylvania, United States
Philadelphia, Pennsylvania, United States
Pittsburgh, Pennsylvania, United States
Beaufort, South Carolina, United States
Charleston, South Carolina, United States
Charleston, South Carolina, United States
Florence, South Carolina, United States
Rapid City, South Dakota, United States
Chattanooga, Tennessee, United States
Germantown, Tennessee, United States
Johnson City, Tennessee, United States
Nashville, Tennessee, United States
Nashville, Tennessee, United States
Abilene, Texas, United States
Austin, Texas, United States
Austin, Texas, United States
Bellaire, Texas, United States
Burleson, Texas, United States
Dallas, Texas, United States
Fort Worth, Texas, United States
Round Rock, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
San Antonio, Texas, United States
Southlake, Texas, United States
Murray, Utah, United States
Salt Lake City, Utah, United States
Lynchburg, Virginia, United States
Norfolk, Virginia, United States
Richmond, Virginia, United States
Roanoke, Virginia, United States
Bellevue, Washington, United States
Silverdale, Washington, United States
Spokane, Washington, United States
La Crosse, Wisconsin, United States
Calgary, Alberta, Canada
Edmonton, Alberta, Canada
New Westminster, British Columbia, Canada
Vancouver, British Columbia, Canada
Etobicoke, Ontario, Canada
Ottawa, Ontario, Canada
Ottawa, Ontario, Canada
Toronto, Ontario, Canada
Toronto, Ontario, Canada
Quebec City, Quebec, Canada
Nice Cedex 1, Alpes Maritimes, France
Dijon, Cote D Or, France
Toulouse, Occitanie, France
Paris Cedex 14, Paris, France
Nantes, Pays De La Loire, France
Marseille, Provence Alpes Cote D Azur, France
Lyon, Rhone Alpes, France
Creteil, Val De Marne, France
Montauban Cedex, , France
Paris, , France
Freiburg, Baden Wuerttemberg, Germany
Ulm, Baden Wuerttemberg, Germany
Bonn, Nordrhein Westfalen, Germany
Muenster, Nordrhein Westfalen, Germany
Ludwigshafen Am Rhein, Rheinland Pfalz, Germany
Hamburg, , Germany
Puettlingen, , Germany
Debrecen, Hajdu Bihar, Hungary
Budapest, , Hungary
Pécs, , Hungary
Cona, Ferrara, Italy
Milan, Milano, Italy
Milan, Milano, Italy
Naples, Napoli, Italy
Rome, Roma, Italy
Rome, Roma, Italy
Negrar, Verona, Italy
Bari, , Italy
Chieti, , Italy
Udine, , Italy
Nagoya Shi, Aichi, Japan
Fukushima Shi, Fukushima, Japan
Kobe Shi, Hyogo, Japan
Nishinomiya Shi, Hyogo, Japan
Kagoshima Shi, Kagoshima, Japan
Kyoto Shi, Kyoto, Japan
Miyazaki Shi, Miyazaki, Japan
Otsu, Shiga, Japan
Bunkyo Ku, Tokyo, Japan
Arecibo, , Puerto Rico
Santiago De Compostela, A Coruna, Spain
L'hospitalet De Llobregat, Barcelona, Spain
Córdoba, Cordoba, Spain
Las Palmas De Gran Canaria, Las Palmas, Spain
Majadahonda, Madrid, Spain
Barcelona, , Spain
Barcelona, , Spain
Barcelona, , Spain
Madrid, , Spain
Madrid, , Spain
Aylesbury, Buckinghamshire, United Kingdom
London, England, United Kingdom
Gloucester, Gloucestershire, United Kingdom
London, Greater London, United Kingdom
London, Greater London, United Kingdom
Southampton, Hampshire, United Kingdom
Oxford, Oxfordshire, United Kingdom
Leeds, West Yorkshire, United Kingdom
Bradford, , United Kingdom
Bristol, , United Kingdom
Liverpool, , United Kingdom
Manchester, , United Kingdom
Newcastle Upon Tyne, , United Kingdom
Sunderland, , United Kingdom
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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