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

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.

Conditions

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

Talk to us

Study Overview

On this page

Study Details

Study overview

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.

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

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

Condition
AMD
Intervention / Treatment

-

Contacts and Locations

Mesa

Barnet Dulaney Perkins Eye Center, Mesa, Arizona, United States, 85016

Phoenix

Retinal Research Institute, Phoenix, Arizona, United States, 85014

Scottsdale

Retina Macula Institute of Arizona, Scottsdale, Arizona, United States, 85255

Bakersfield

California Retina Consultants, Bakersfield, California, United States, 93309

Beverly Hills

Retina Vitreous Associates Medical Group, Beverly Hills, California, United States, 90211

Campbell

Retinal Diagnostic Center, Campbell, California, United States, 95008

Encino

The Retina Partners, Encino, California, United States, 91436

Fullerton

Retina Consultants of Orange County, Fullerton, California, United States, 92835

La Jolla

Hamilton Glaucoma Center Shiley Eye Center UCSD, La Jolla, California, United States, 92093

Palo Alto

Byers Eye Institute Stanford, Palo Alto, California, United States, 94303

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.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 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.

Ages Eligible for Study

50 Years to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

AbbVie,

Study Record Dates

2026-11