Diabetic Retinopathy, DR
Conditions
Keywords
Diabetic Retinopathy, DR, Gene Therapy
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.
Interventions
DRUGStandard of Care
Standard of Care
DRUGAflibercept
Injection
Sponsors
AbbVie
REGENXBIO Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Incidence of ocular adverse events (AEs) and any serious adverse events (SAEs) | 5 years inclusive of the parent study | To evaluate the long-term safety of ABBV-RGX-314 |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
| Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in CST as measured by SD-OCT | 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 | 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 number of anti-VEGF injections through years 2, 3, 4, and 5 based on ongoing chart review in the study eye (DL4 participants only) | 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) | 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) | 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) | 5 years, inclusive to the parent study |
| Proportion of participants with any sight-threatening ocular diabetic complications | 5 years, inclusive to the parent study |
| Mean number of retina specialist visits attended for complications of DR based on chart review | 5 years, inclusive to the parent study |
Countries
United States
Outcome results
None listed