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

• Sponsor: REGENXBIO, Inc. (Industry)
• Overall Status: Enrolling by invitation
• CT.gov ID: NCT05210803
• Collaborator: (none)
• Enrollment: 95
• Locations: 15
• Anticipated Duration (Months): 64.5
• Patients Per Site: 6.3
• Patients Per Site Per Month: 0.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Neovascular Age-Related Macular Degeneration (nAMD); Gene Therapy; AMD; Wet AMD; wAMD; nAMD	Other: No intervention.

Study Design

• Study Type: Observational
• Anticipated Enrollment: 95 participants
• Observational Model: Other
• Time Perspective: Prospective
• 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
• Actual Study Start Date: Dec 20, 2021
• Anticipated Primary Completion Date: Dec 26, 2026
• Anticipated Study Completion Date: May 7, 2027

Arms and Interventions

Arm	Intervention/Treatment
Roll over No intervention All subjects that previously received RGX-314 in a parent study	Other: No intervention.; All subjects that previously received RGX-314 in a parent study

Outcome Measures

Primary Outcome Measures

1. To evaluate the long-term safety of RGX-314 [5 years inclusive of parent study]

   Incidences of ocular Adverse Events and Serious Adverse Events, and all Adverse Events of Special Interest

Secondary Outcome Measures

1. • To evaluate the persistence of effect of RGX-314 on best corrected visual acuity (BCVA) [5 years inclusive of parent study]

   • Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in BCVA

2. • 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]

   • Mean change from baseline (ie, prior to RGX-314 administration in the parent study) in CRT as measured by SD-OCT

3. • To assess the need for supplemental anti-vascular endothelial growth factor (anti-VEGF) therapy [5 years inclusive of parent study]

   • Mean number of supplemental anti-VEGF injections based on chart review

4. • To assess the need of clinic visits for management of nAMD [5 years inclusive of parent study]

   • Mean number of retina specialist visits attended for nAMD based on chart review

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Phoenix Location	Phoenix	Arizona	United States	85014
2	Bakersfield Location	Bakersfield	California	United States	93309
3	Beverly Hills Location	Beverly Hills	California	United States	90211
4	Mountain View Location	Mountain View	California	United States	94040
5	Poway Location	Poway	California	United States	92064
6	Santa Barbara location	Santa Barbara	California	United States	93103
7	Augusta Location	Augusta	Georgia	United States	30909
8	Baltimore Location	Baltimore	Maryland	United States	21205
9	Boston location	Boston	Massachusetts	United States	02114
10	Reno Location	Reno	Nevada	United States	89502
11	Albuquerque Location	Albuquerque	New Mexico	United States	87109
12	Philadelphia location	Philadelphia	Pennsylvania	United States	19107
13	Germantown Location	Germantown	Tennessee	United States	38138
14	Nashville Location	Nashville	Tennessee	United States	37203
15	Woodlands Location	The Woodlands	Texas	United States	77384

Sponsors and Collaborators

• REGENXBIO, Inc.

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: REGENXBIO, Inc.
• ClinicalTrials.gov Identifier: NCT05210803
• Other Study ID Numbers: RGX-314-5102
• First Posted: Jan 27, 2022
• Last Update Posted: Jan 27, 2022
• Last Verified: Jan 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Macular Degeneration; Wet Macular Degeneration

Study Results

No Results Posted as of Jan 27, 2022