Long-Term Follow-Up Study of RGX-314 Administered in the Suprachoroidal Space for Participants With nAMD

AMD Clinical Trial

Official title:

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

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT05210803
• Other study ID #: RGX-314-5102
• Status: Enrolling by invitation
• Start date: December 20, 2021
• Est. completion date: March 2028

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 115
• Est. completion date: March 2028
• Est. primary completion date: March 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

1. Must provide written, signed informed consent for this study.

2. 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.

3. Must be willing and able to comply with all study procedures.

Exclusion Criteria:

1. None

Related Conditions & MeSH terms

• AMD
• Gene Therapy
• Macular Degeneration
• nAMD
• Neovascular Age-Related Macular Degeneration (nAMD)
• wAMD
• Wet AMD
• Wet Macular Degeneration

Intervention

Other:
• No intervention.
All subjects that previously received RGX-314 in a parent study

Locations

Country	Name	City	State
United States	Vision Research Center Eye Associates of New Mexico	Albuquerque	New Mexico
United States	Southeast Retina Center PC	Augusta	Georgia
United States	California Retina Consultants	Bakersfield	California
United States	Johns Hopkins University	Baltimore	Maryland
United States	Retina-Vitreous Associates Medical Group	Beverly Hills	California
United States	Ophthalmic Consultants of Boston	Boston	Massachusetts
United States	Vitreoretinal Surgery PLLC	Edina	Minnesota
United States	Charles Retina Institute, P.C	Germantown	Tennessee
United States	Northern California Retina Vitreous Associates Medical Group Inc	Mountain View	California
United States	Tennessee Retina, PC	Nashville	Tennessee
United States	Retinovitreous Associates, LTD	Philadelphia	Pennsylvania
United States	Retinal Research Institute, LLC	Phoenix	Arizona
United States	Retina Consultants San Diego	Poway	California
United States	Sierra eye Associates	Reno	Nevada
United States	California Retina Consultants	Santa Barbara	California
United States	Retina Consultants of Texas	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To evaluate the long-term safety of RGX-314	Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest	5 years inclusive of parent study
Secondary	• To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA)	• Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA	5 years inclusive of parent study
Secondary	• To evaluate the persistence of effect of RGX-314 on central retinal thickness (CRT), as measured by spectral domain-optical coherence tomography (SD-OCT)	• Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in CRT as measured by SD-OCT	5 years inclusive of parent study
Secondary	• To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy	• Mean number of supplemental anti-VEGF injections based on chart review	5 years inclusive of parent study
Secondary	• To assess the need of clinic visits for management of nAMD	• Mean number of retina specialist visits attended for nAMD based on chart review	5 years inclusive of parent study