A Long-term Follow-Up Study to Evaluate the Safety and Efficacy of Suprachoroidal Administration of RGX-314 for Participants With Neovascular Age-Related Macular Degeneration
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Neovascular Age-Related Macular Degeneration (nAMD)
- Sponsor
- AbbVie
- Enrollment
- 115
- Locations
- 15
- Primary Endpoint
- To evaluate the long-term safety of RGX-314
- Status
- Enrolling by Invitation
- Last Updated
- 10 months ago
Overview
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 nAMD in which they received suprachoroidal space (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 up to 5 years after 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.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Must provide written, signed informed consent for this study.
- •Must have been enrolled in a previous clinical study of RGX-314 in the treatment of nAMD and must have received an SCS injection of RGX-314 in that study.
- •Must be willing and able to comply with all study procedures.
Exclusion Criteria
- Not provided
Outcomes
Primary Outcomes
To evaluate the long-term safety of RGX-314
Time Frame: 5 years inclusive of parent study
Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest
Secondary Outcomes
- • To evaluate the persistence of effect of RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)(5 years inclusive of parent study)
- • To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA)(5 years inclusive of parent study)
- • To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy(5 years inclusive of parent study)
- • To assess the need of clinic visits for management of nAMD(5 years inclusive of parent study)