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

A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy Without Center Involved-Diabetic Macular Edema

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.

Study Overview

• Status: Enrolling by invitation
• Conditions: Diabetic Retinopathy, DR
• Intervention / Treatment: Other: No Intervention

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Phoenix, Arizona, United States, 85014
      • Retinal Research Institute, LLC
  • California
    • Bakersfield, California, United States, 93309
      • California Retina Consultants
    • Beverly Hills, California, United States, 90211
      • Retina-Vitreous Associates Medical Group
    • Los Angeles, California, United States, 90017
      • American Institute of Research
    • Mountain View, California, United States, 94040
      • Northern California Retina Vitreous Associates Medical Group Inc
    • Pasadena, California, United States, 91107
      • California Eye Specialists Medical Group, Inc
    • Poway, California, United States, 92064
      • Retina Consultants San Diego
    • Santa Barbara, California, United States, 93103
      • California Retina Consultants CRC
  • Illinois
    • Oak Forest, Illinois, United States, 60452
      • University Retina and Macula Associates, PC
  • Maryland
    • Hagerstown, Maryland, United States, 21740
      • Cumberland Valley Retina Consultants
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Ophthalmic Consultants of Boston
  • Nevada
    • Reno, Nevada, United States, 89502
      • Sierra Eye Associates
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • New Jersey Retina
  • New Mexico
    • Albuquerque, New Mexico, United States, 87109
      • Vision Research Center Eye Associates of New Mexico
  • North Carolina
    • Durham, North Carolina, United States, 27705
      • Duke University
  • Pennsylvania
    • Philadelphia, Pennsylvania, United States, 19107
      • Retinovitreous Associates, LTD
  • Tennessee
    • Germantown, Tennessee, United States, 38138
      • Charles Retina Institute, P.C
  • Texas
    • Austin, Texas, United States, 78750
      • Austin Clinical Research
    • The Woodlands, Texas, United States, 77384
      • Retina Consultants of Texas

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Study population includes participants who received RGX-314 in a parent study of DR without center involved-diabetic macular edema

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Roll Over; No intervention - all subjects that previously received RGX-314 in a parent study	Other: No Intervention; All subjects that previously received RGX-314 in a parent study

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the long-term safety of RGX-314	Incidence of overall and ocular adverse events, serious adverse events, and all adverse events of special interest	5 years inclusive of the parent study

Secondary Outcome Measures

Outcome Measure	Time Frame
Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in DR by ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography	5 years, inclusive of the parent study
Proportion of participants achieving 0-step (no change), a 1-step or greater, a 2-step or greater, or a 3-step or greater improvement in DR per ETDRS-DRSS on 4-widefield digital stereoscopic fundus photography from baseline	5 years, inclusive to the parent study
Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA	5 years, inclusive to the parent study
Proportion of participants gaining or losing ≥5, 10 and 15 letters in BCVA compared with baseline (ie, prior to RGX-314 administration in the parent study)	5 years, inclusive to the parent study
Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in central subfield thickness as measured by SD-OCT	5 years, inclusive to the parent study
Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA	5 years, inclusive to the parent study
Proportion of participants requiring any additional intervention for ocular diabetic complications (eg, anti-VEGF intravitreal injection or PRP)	5 years, inclusive to the parent study
Proportion of participants with any sight-threatening ocular diabetic complications	5 years, inclusive to the parent study

Collaborators and Investigators

• Sponsor: AbbVie
• Collaborators: AbbVie

Study record dates

Study Major Dates

• Study Start (Actual): April 4, 2022
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): May 1, 2028

Study Registration Dates

• First Submitted: March 16, 2022
• First Submitted That Met QC Criteria: March 16, 2022
• First Posted (Actual): March 25, 2022

Study Record Updates

• Last Update Posted (Actual): June 18, 2025
• Last Update Submitted That Met QC Criteria: June 16, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Diabetic Retinopathy, DR
• Additional Relevant MeSH Terms: Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Diabetes Mellitus; Eye Diseases; Diabetic Angiopathies; Diabetes Complications; Retinal Diseases; Diabetic Retinopathy
• Other Study ID Numbers: RGX-314-5201

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No