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

Last updated: June 25, 2024
Sponsor: AbbVie
Overall Status: Active - Recruiting

Phase

2

Condition

Macular Degeneration

Geographic Atrophy

Treatment

Topical Steroid

RGX-314 Dose 1

RGX-314 Dose 2

Clinical Study ID

NCT04514653
RGX-314-2102
  • Ages 50-89
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion 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.

Exclusion

Exclusion Criteria:

  • 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 steroidinjection or investigational product (IP), other than anti-VEGF therapy, in the 6months prior to study entry.

  • Received any gene therapy.

  • Any condition preventing visualization of the fundus or VA improvement in the studyeye, 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 attackswithin 6 months of study entry.

  • Cohorts 1 - 5 only: Uncontrolled glaucoma in the study eye.

COHORT 6 ONLY:

  • 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 atVisit 1.

Note: Other inclusion/exclusion criteria apply.

Study Design

Total Participants: 115
Treatment Group(s): 8
Primary Treatment: Topical Steroid
Phase: 2
Study Start date:
August 25, 2020
Estimated Completion Date:
August 01, 2026

Study Description

This phase 2, randomized, dose-escalation study is designed to evaluate the efficacy, safety and tolerability of RGX-314 gene therapy in subjects with nAMD. Approximately 115 participants who meet the inclusion/exclusion criteria will be enrolled into one of 6 cohorts. Participants will be randomized in Cohorts 1 and 2 to receive RGX-314 or ranibizumab control, and participants enrolled in Cohorts 3 through 5 will receive RGX-314. Participants enrolled in Cohort 6 will receive RGX-314 and will be randomized to one of two different post-procedural steroid regimens. Cohort 1 will evaluate RGX-314 Dose 1, Cohorts 2 and 3 will evaluate RGX-314 Dose 2, and Cohorts 4, 5, and 6 will evaluate RGX-314 Dose 3. Participants will be evaluated for efficacy, safety and tolerability of RGX-314 throughout the study.

Connect with a study center

  • Phoenix Location

    Phoenix, Arizona 85014
    United States

    Active - Recruiting

  • Bakersfield Location

    Bakersfield, California 93309
    United States

    Site Not Available

  • Beverly Hills Location

    Beverly Hills, California 90211
    United States

    Active - Recruiting

  • Mountain View Location

    Mountain View, California 94040
    United States

    Active - Recruiting

  • Poway Location

    Poway, California 92064
    United States

    Active - Recruiting

  • Santa Barbara Location

    Santa Barbara, California 93103
    United States

    Site Not Available

  • Augusta Location

    Augusta, Georgia 30909
    United States

    Active - Recruiting

  • Baltimore Location

    Baltimore, Maryland 21287
    United States

    Active - Recruiting

  • Boston Location

    Boston, Massachusetts 02114
    United States

    Active - Recruiting

  • Reno Location

    Reno, Nevada 89502
    United States

    Active - Recruiting

  • Albuquerque Location

    Albuquerque, New Mexico 87109
    United States

    Active - Recruiting

  • Philadelphia Location

    Philadelphia, Pennsylvania 19107
    United States

    Active - Recruiting

  • Germantown Location

    Germantown, Tennessee 38138
    United States

    Site Not Available

  • Nashville Location

    Nashville, Tennessee 37203
    United States

    Site Not Available

  • Woodlands Location

    The Woodlands, Texas 77384
    United States

    Site Not Available

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.