Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With and Without Diabetic Retinopathy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Standard of Care, Aflibercept.
- Who it may be relevant to
- Registry conditions: Diabetic Retinopathy, DR. Basic parameters: No limits · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
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
Overview
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.
Interventions
- Drug Standard of Care
Standard of Care - Drug Aflibercept
Injection
Primary outcome measures
- Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs) [Time frame: 5 years inclusive of the parent study]
Secondary outcome measures (12)
- Incidences of non-ocular AEs and any Adverse Events of Special Interest [Time frame: 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 [Time frame: 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) [Time frame: 5 years, inclusive to the parent study]
- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA [Time frame: 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) [Time frame: 5 years, inclusive to the parent study]
- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CST as measured by SD-OCT [Time frame: 5 years, inclusive to the parent study]
- Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in the area of retinal nonperfusion on ultra-widefield Optos FA [Time frame: 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) [Time frame: 5 years, inclusive to the parent study]
- Mean number of anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only) [Time frame: 5 years, inclusive to the parent study]
- Mean number of anti-VEGF injections in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only) [Time frame: 5 years, inclusive to the parent study]
- Mean anti-VEGF injection annualized rate through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only) [Time frame: 5 years, inclusive to the parent study]
- Mean anti-VEGF injection annualized rate in years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only) [Time frame: 5 years, inclusive to the parent study]
Eligibility criteria
Inclusion criteria
- 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
Exclusion criteria
- None
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
United States · 20 centers
- Retinal Research Institute, LLC — Phoenix
- California Retina Consultants — Bakersfield
- Retina-Vitreous Associates Medical Group — Beverly Hills
- Retinal Diagnostic Center — Los Angeles
- Northern California Retina Vitreous Associates Medical Group Inc — Mountain View
- California Eye Specialists Medical Group, Inc — Pasadena
- Retina Consultants San Diego — Poway
- California Retina Consultants CRC — Santa Barbara
- … and 12 more centers
Identifiers
NCT: NCT05296447 · RGX-314-5201 (M23-420) · M23-420