Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy
- Conditions
- Diabetic Retinopathy, DR
- Interventions
- Other: No Intervention
- Registration Number
- NCT05296447
- Lead Sponsor
- AbbVie
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ENROLLING_BY_INVITATION
- Sex
- All
- Target Recruitment
- 100
- 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
- None
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Roll Over No Intervention No intervention - all subjects that previously received RGX-314 in a parent study
- Primary Outcome Measures
Name Time Method To evaluate the long-term safety of RGX-314 5 years inclusive of the parent study Incidence of overall and ocular adverse events, serious adverse events, and all adverse events of special interest
- Secondary Outcome Measures
Name Time Method Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA 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 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 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 Proportion of participants with any sight-threatening ocular diabetic complications 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 the area of retinal nonperfusion on ultra-widefield Optos FA 5 years, inclusive to the parent study
Trial Locations
- Locations (19)
Retina-Vitreous Associates Medical Group
🇺🇸Beverly Hills, California, United States
University Retina and Macula Associates, PC
🇺🇸Oak Forest, Illinois, United States
Retina Consultants San Diego
🇺🇸Poway, California, United States
California Eye Specialists Medical Group, Inc
🇺🇸Pasadena, California, United States
Vision Research Center Eye Associates of New Mexico
🇺🇸Albuquerque, New Mexico, United States
New Jersey Retina
🇺🇸Teaneck, New Jersey, United States
Charles Retina Institute, P.C
🇺🇸Germantown, Tennessee, United States
Sierra eye Associates
🇺🇸Reno, Nevada, United States
Retina Consultants of Texas
🇺🇸The Woodlands, Texas, United States
Retinal Research Institute, LLC
🇺🇸Phoenix, Arizona, United States
Northern California Retina Vitreous Associates Medical Group Inc
🇺🇸Mountain View, California, United States
Austin Clinical Research
🇺🇸Austin, Texas, United States
California Retina Consultants
🇺🇸Bakersfield, California, United States
American Institute of Research
🇺🇸Los Angeles, California, United States
California Retina Consultants CRC
🇺🇸Santa Barbara, California, United States
Ophthalmic Consultants of Boston
🇺🇸Boston, Massachusetts, United States
Duke University
🇺🇸Durham, North Carolina, United States
Cumberland Valley Retina Consultants
🇺🇸Hagerstown, Maryland, United States
Retinovitreous Associates, LTD
🇺🇸Philadelphia, Pennsylvania, United States