Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Diabetic Retinopathy With and Without Center Involved-Diabetic Macular Edema
2 other identifiers
interventional
100
1 country
20
Brief Summary
This is a prospective study designed to evaluate the long-term safety and efficacy of ABBV-RGX-314. Eligible participants are those who were previously enrolled in a clinical study of DR with and without center involved-diabetic macular edema (CI-DME) in which they received suprachoroidal space (SCS) administration of ABBV-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-ABBV-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 ABBV-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 phase_2
Started Apr 2022
Longer than P75 for phase_2
20 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
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
June 1, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
June 1, 2031
August 5, 2026
August 1, 2026
9.2 years
March 16, 2022
August 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs)
To evaluate the long-term safety of ABBV-RGX-314
5 years inclusive of the parent study
Secondary Outcomes (14)
Incidences of non-ocular AEs and any Adverse Events of Special Interest
5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in DR by ETDRS-DRSS on digital stereoscopic fundus photography
5 years, inclusive of the parent study
Proportion of participants achieving 0-step (no change), a ≥1-step, a ≥2-step, or a ≥3-step or greater change in DR per ETDRS-DRSS on digital stereoscopic fundus photography from baseline (ie, prior to ABBV-RGX-314 administration in the parent study)
5 years, inclusive to the parent study
Mean change from baseline (ie, prior to ABBV-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 ABBV-RGX-314 administration in the parent study)
5 years, inclusive to the parent study
- +9 more secondary outcomes
Study Arms (2)
Standard of Care
OTHERDose Level (DL) 1-3 participants who received ABBV-RGX-314 in a parent study will continue to receive standard of care for the study duration.
Supplemental Treatment
OTHERDL4 participants from parent study will be eligible to receive supplement aflibercept through a prespecified timepoint based on protocol-specified criteria if they develop worsening CI-DME or high-risk proliferative diabetic retinopathy (PDR) in the study eye.
Interventions
Eligibility Criteria
You may qualify if:
- Must provide written, signed informed consent for this study
- Must have been enrolled in a previous clinical study of ABBV-RGX-314 for the treatment of DR with or without CI-DME and must have received an SCS injection of ABBV-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
- REGENXBIO Inc.collaborator
Study Sites (20)
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
Retinal Diagnostic Center
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
Southeast Retina Center, PC
Augusta, Georgia, 30909, 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
Mid Atlantic Retina
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- 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)
June 1, 2031
Study Completion (Estimated)
June 1, 2031
Last Updated
August 5, 2026
Record last verified: 2026-08
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
- Access Criteria
- To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/
AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.