RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD) (AAVIATE)

Description

RGX-314 is being developed as a potential novel one-time gene therapy treatment 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-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 twelve 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.

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

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Study Overview

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Study Details

Study overview

RGX-314 is being developed as a potential novel one-time gene therapy treatment 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-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 twelve 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.

A Phase 2, Randomized, Dose-escalation, Ranibizumab-controlled Study to Evaluate the Efficacy, Safety, and Tolerability of RGX-314 Gene Therapy Delivered Via One or Two Suprachoroidal Space (SCS) Injections in Participants With Neovascular Age-Related Macular Degeneration (nAMD) (AAVIATE)

RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD) (AAVIATE)

Condition
Neovascular Age-Related Macular Degeneration (nAMD)
Intervention / Treatment

-

Contacts and Locations

Phoenix

Phoenix Location, Phoenix, Arizona, United States, 85014

Bakersfield

Bakersfield Location, Bakersfield, California, United States, 93309

Beverly Hills

Beverly Hills Location, Beverly Hills, California, United States, 90211

Mountain View

Mountain View Location, Mountain View, California, United States, 94040

Poway

Poway Location, Poway, California, United States, 92064

Santa Barbara

Santa Barbara Location, Santa Barbara, California, United States, 93103

Augusta

Augusta Location, Augusta, Georgia, United States, 30909

Baltimore

Baltimore Location, Baltimore, Maryland, United States, 21287

Boston

Boston Location, Boston, Massachusetts, United States, 02114

Reno

Reno Location, Reno, Nevada, United States, 89502

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

  • * Age \>/= 50 and \</= 89
  • * Diagnosis of CNV secondary to age-related macular degeneration in the study eye.
  • * Participants must have demonstrated a meaningful response to anti-VEGF therapy.
  • * Willing and able to provide written, signed informed consent for this study.
  • * CNV or macular edema in the study eye secondary to any causes other than AMD.
  • * Subfoveal fibrosis or atrophy in study eye.
  • * Participants who have had a prior vitrectomy.
  • * Active or history of retinal detachment in the study eye.
  • * History of intravitreal therapy in the study eye, such as intravitreal steroid injection or investigational product (IP), other than anti-VEGF therapy, in the 6 months prior to study entry.
  • * Received any gene therapy.
  • * Any condition preventing visualization of the fundus or VA improvement in the study eye, eg, cataract.
  • * History of intraocular surgery in the study eye within 12 weeks of study entry.
  • * Receipt of any IP within 30 days of study entry or 5 half-lives of the IP.
  • * Myocardial infarction, cerebrovascular accident, or transient ischemic attacks within 6 months of study entry.
  • * Cohorts 1 - 5 only: Uncontrolled glaucoma in the study eye.
  • * Active or history of glaucoma or ocular hypertension in the study eye.
  • * Certain OCT characteristics including: Large Pigment Epithelial Detachments (PED), clinically significant Epiretinal Membrane (ERM) in the study eye at Visit 1.

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

2026-08-01