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
1 other identifier
observational
100
1 country
19
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Apr 2022
Longer than P75 for all trials
19 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 16, 2022
CompletedFirst Posted
Study publicly available on registry
March 25, 2022
CompletedStudy Start
First participant enrolled
April 4, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2028
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 1, 2028
June 18, 2025
June 1, 2025
6.1 years
March 16, 2022
June 16, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (8)
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
- +3 more secondary outcomes
Study Arms (1)
Roll Over
No intervention - all subjects that previously received RGX-314 in a parent study
Interventions
Eligibility Criteria
Study population includes participants who received RGX-314 in a parent study of DR without center involved-diabetic macular edema
You may qualify if:
- 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
You may not qualify if:
- None
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (19)
Retinal Research Institute, LLC
Phoenix, Arizona, 85014, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
American Institute of Research
Los Angeles, California, 90017, United States
Northern California Retina Vitreous Associates Medical Group Inc
Mountain View, California, 94040, United States
California Eye Specialists Medical Group, Inc
Pasadena, California, 91107, United States
Retina Consultants San Diego
Poway, California, 92064, United States
California Retina Consultants CRC
Santa Barbara, California, 93103, United States
University Retina and Macula Associates, PC
Oak Forest, Illinois, 60452, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Sierra eye Associates
Reno, Nevada, 89502, United States
New Jersey Retina
Teaneck, New Jersey, 07666, United States
Vision Research Center Eye Associates of New Mexico
Albuquerque, New Mexico, 87109, United States
Duke University
Durham, North Carolina, 27705, United States
Retinovitreous Associates, LTD
Philadelphia, Pennsylvania, 19107, United States
Charles Retina Institute, P.C
Germantown, Tennessee, 38138, United States
Austin Clinical Research
Austin, Texas, 78750, United States
Retina Consultants of Texas
The Woodlands, Texas, 77384, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- observational
- Observational Model
- OTHER
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2022
First Posted
March 25, 2022
Study Start
April 4, 2022
Primary Completion (Estimated)
May 1, 2028
Study Completion (Estimated)
May 1, 2028
Last Updated
June 18, 2025
Record last verified: 2025-06
Data Sharing
- IPD Sharing
- Will not share