Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD

NCT ID: NCT05210803

Last Updated: 2025-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Total Enrollment

115 participants

Study Classification

OBSERVATIONAL

Study Start Date

2021-12-20

Study Completion Date

2028-03-31

Brief Summary

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This is a prospective, observational study designed to evaluate the long-term safety and efficacy of RGX-314. Eligible participants are those who were previously enrolled in a clinical study of nAMD in which they received suprachoroidal space (SCS) administration of RGX-314. Enrollment of each participant in the current study should occur after the participant has completed either the end of study or early discontinuation visit in the previous (parent) clinical study. Participants will be followed for up to 5 years after RGX-314 administration (inclusive of the parent study). As such, the total study duration for each participant may vary depending on when they enroll in the current study following RGX-314 administration in the parent study.

Detailed Description

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Conditions

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Neovascular Age-Related Macular Degeneration (nAMD) Gene Therapy AMD Wet AMD wAMD nAMD

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Study Groups

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Roll over

No intervention All subjects that previously received RGX-314 in a parent study

No intervention.

Intervention Type OTHER

All subjects that previously received RGX-314 in a parent study

Interventions

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No intervention.

All subjects that previously received RGX-314 in a parent study

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

1. Must provide written, signed informed consent for this study.
2. Must have been enrolled in a previous clinical study of RGX-314 in the treatment of nAMD and must have received an SCS injection of RGX-314 in that study.
3. Must be willing and able to comply with all study procedures.

Exclusion Criteria

1\. None
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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AbbVie

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Retinal Research Institute, LLC

Phoenix, Arizona, United States

Site Status

California Retina Consultants

Bakersfield, California, United States

Site Status

Retina-Vitreous Associates Medical Group

Beverly Hills, California, United States

Site Status

Northern California Retina Vitreous Associates Medical Group Inc

Mountain View, California, United States

Site Status

Retina Consultants San Diego

Poway, California, United States

Site Status

California Retina Consultants

Santa Barbara, California, United States

Site Status

Southeast Retina Center PC

Augusta, Georgia, United States

Site Status

Johns Hopkins University

Baltimore, Maryland, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Vitreoretinal Surgery PLLC

Edina, Minnesota, United States

Site Status

Sierra eye Associates

Reno, Nevada, United States

Site Status

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, United States

Site Status

Retinovitreous Associates, LTD

Philadelphia, Pennsylvania, United States

Site Status

Charles Retina Institute, P.C

Germantown, Tennessee, United States

Site Status

Tennessee Retina, PC

Nashville, Tennessee, United States

Site Status

Retina Consultants of Texas

The Woodlands, Texas, United States

Site Status

Countries

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United States

Other Identifiers

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RGX-314-5102

Identifier Type: -

Identifier Source: org_study_id

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