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

NCT ID: NCT05296447

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

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-04

Study Completion Date

2028-05-31

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 DR without center involved-diabetic macular edema (CI-DME) in which they received 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 a total of 5 years post-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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Diabetic Retinopathy, DR

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

* Must provide written, signed informed consent for this study
* Must have been enrolled in a previous clinical study of RGX-314 for the treatment of DR without CI-DME and must have received an SCS injection of RGX-314 in that study
* Must be willing and able to comply with all study procedures

Exclusion Criteria

* 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

American Institute of Research

Los Angeles, California, United States

Site Status

Northern California Retina Vitreous Associates Medical Group Inc

Mountain View, California, United States

Site Status

California Eye Specialists Medical Group, Inc

Pasadena, California, United States

Site Status

Retina Consultants San Diego

Poway, California, United States

Site Status

California Retina Consultants CRC

Santa Barbara, California, United States

Site Status

University Retina and Macula Associates, PC

Oak Forest, Illinois, United States

Site Status

Cumberland Valley Retina Consultants

Hagerstown, Maryland, United States

Site Status

Ophthalmic Consultants of Boston

Boston, Massachusetts, United States

Site Status

Sierra eye Associates

Reno, Nevada, United States

Site Status

New Jersey Retina

Teaneck, New Jersey, United States

Site Status

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, United States

Site Status

Duke University

Durham, North Carolina, United States

Site Status

Retinovitreous Associates, LTD

Philadelphia, Pennsylvania, United States

Site Status

Charles Retina Institute, P.C

Germantown, Tennessee, United States

Site Status

Austin Clinical Research

Austin, Texas, 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-314-5201

Identifier Type: -

Identifier Source: org_study_id

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