RECRUITING

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

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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.

Official Title

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)

Quick Facts

Study Start:2020-08-25
Study Completion:2026-08-01
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT04514653

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.

Ages Eligible for Study:50 Years to 89 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Age \>/= 50 and \</= 89
  2. * Diagnosis of CNV secondary to age-related macular degeneration in the study eye.
  3. * Participants must have demonstrated a meaningful response to anti-VEGF therapy.
  4. * Willing and able to provide written, signed informed consent for this study.
  1. * CNV or macular edema in the study eye secondary to any causes other than AMD.
  2. * Subfoveal fibrosis or atrophy in study eye.
  3. * Participants who have had a prior vitrectomy.
  4. * Active or history of retinal detachment in the study eye.
  5. * 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.
  6. * Received any gene therapy.
  7. * Any condition preventing visualization of the fundus or VA improvement in the study eye, eg, cataract.
  8. * History of intraocular surgery in the study eye within 12 weeks of study entry.
  9. * Receipt of any IP within 30 days of study entry or 5 half-lives of the IP.
  10. * Myocardial infarction, cerebrovascular accident, or transient ischemic attacks within 6 months of study entry.
  11. * Cohorts 1 - 5 only: Uncontrolled glaucoma in the study eye.
  12. * Active or history of glaucoma or ocular hypertension in the study eye.
  13. * Certain OCT characteristics including: Large Pigment Epithelial Detachments (PED), clinically significant Epiretinal Membrane (ERM) in the study eye at Visit 1.

Contacts and Locations

Study Contact

Patient Advocacy
CONTACT
1-833-711-0349
patientadvocacy@regenxbio.com

Study Locations (Sites)

Phoenix Location
Phoenix, Arizona, 85014
United States
Bakersfield Location
Bakersfield, California, 93309
United States
Beverly Hills Location
Beverly Hills, California, 90211
United States
Mountain View Location
Mountain View, California, 94040
United States
Poway Location
Poway, California, 92064
United States
Santa Barbara Location
Santa Barbara, California, 93103
United States
Augusta Location
Augusta, Georgia, 30909
United States
Baltimore Location
Baltimore, Maryland, 21287
United States
Boston Location
Boston, Massachusetts, 02114
United States
Reno Location
Reno, Nevada, 89502
United States
Albuquerque Location
Albuquerque, New Mexico, 87109
United States
Philadelphia Location
Philadelphia, Pennsylvania, 19107
United States
Germantown Location
Germantown, Tennessee, 38138
United States
Nashville Location
Nashville, Tennessee, 37203
United States
Woodlands Location
The Woodlands, Texas, 77384
United States

Collaborators and Investigators

Sponsor: AbbVie

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-08-25
Study Completion Date2026-08-01

Study Record Updates

Study Start Date2020-08-25
Study Completion Date2026-08-01

Terms related to this study

Keywords Provided by Researchers

  • AMD
  • wet AMD
  • wAMD
  • nAMD

Additional Relevant MeSH Terms

  • Neovascular Age-Related Macular Degeneration (nAMD)