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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05210803
Other study ID # RGX-314-5102
Secondary ID
Status Enrolling by invitation
Phase
First received
Last updated
Start date December 20, 2021
Est. completion date March 2028

Study information

Verified date May 2023
Source AbbVie
Contact n/a
Is FDA regulated No
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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