Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time 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 or nAMD). 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 (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.

Conditions

AMD, nAMD, Wet Age-related Macular Degeneration, wAMD, Wet AMD, CNV, Neovascular AMD, Neovascular Age-related Macular Degeneration, Choroidal Neovascularization

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Study Overview

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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 or nAMD). 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 (anti-VEGF) therapies have significantly changed the landscape for treatment of wet AMD, becoming the standard of care due to their ability to maintain or prevent progression of vision loss in the majority of patients. These therapies, however, require life-long intraocular injections, typically repeated every 4 to 16 weeks in frequency, to maintain efficacy. Due to the burden of these treatments, patients often experience a decline in vision with reduced frequency of treatment over time.

A Randomized, Partially Masked, Controlled, Phase 2b/3 Clinical Study to Evaluate the Efficacy and Safety of RGX-314 Gene Therapy in Participants With nAMD (ATMOSPHERE)

Pivotal 1 Study of ABBV-RGX-314 (Also Known as RGX-314) Gene Therapy Administered Via Subretinal Delivery One Time in Participants With nAMD

Condition
AMD
Intervention / Treatment

-

Contacts and Locations

Phoenix

118-Retinal Consultants of Arizona, Ltd., Phoenix, Arizona, United States, 85053

Sun City

170-Barnet Dulaney Perkins Eye Center, Sun City, Arizona, United States, 85351-2146

Little Rock

292-Univ of Arkansas Medical Sciences Jones Eye Institute, Little Rock, Arkansas, United States, 72205

Beverly Hills

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

Campbell

142-Retinal Diagnostic Center, Campbell, California, United States, 95008-6770

Encino

160-The Retina Partners - Encino, Encino, California, United States, 91436-2018

Fullerton

150-Retina Consultants of Orange County - Fullerton Office, Fullerton, California, United States, 92835

Huntington Beach

284- Salehi Retina Institute, Huntington Beach, California, United States, 92647-3601

Irvine

193-University of California Irvine - School of Medicine - The Gavin Herbert Eye Institute, Irvine, California, United States, 92697

Los Angeles

187-Doheny Eye Institute - Doheny Eye Center, Los Angeles, California, United States, 90033-1035

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 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, 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

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

2026-05