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

NCT05210803 | Enrolling By Invitation Phase 2 DMC FDA Drug

• 2 other identifiers: RGX-314-5102 (M23-421)M23-421
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 16

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 nAMD 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 up to 5 years after 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.

Conditions

Neovascular Age-Related Macular Degeneration (nAMD)

Keywords

Gene Therapy; AMD; wet AMD; wAMD; nAMD

Outcome Measures

Primary Outcomes (1)

• Incidences of ocular Adverse Events and any Serious Adverse Events

  To evaluate the long-term safety of ABBV-RGX-314

  5 years inclusive of parent study

Secondary Outcomes (9)

• Incidences of non-ocular Adverse Events and any Adverse Events of Special Interest

  5 years inclusive of parent study

• Mean change from baseline (ie, prior to ABBV-RGX-314 administration in the parent study) in BCVA based on ETDRS score in the study eye at assessed timepoints

  5 years inclusive of parent study

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

  5 years inclusive of parent study

• Mean number of supplemental anti-VEGF injections through years 2, 3, 4 and 5

  5 years inclusive of parent study

• Mean number of supplemental anti-VEGF injections in years 2, 3, 4, and 5

  5 years inclusive of parent study

Study Arms (2)

Standard of Care

OTHER

Dose Level (DL) 1-3 participants who received ABBV-RGX- 314 in the parent study will continue to receive standard of care for the study duration.

Drug: Standard of Care

Supplemental Treatment

OTHER

DL 4 participants from the parent study will be able to receive supplement ranibizumab based on protocol-specified criteria if they develop worsening nAMD activity.

Drug: Standard of Care; Drug: Ranibizumab

Interventions

Standard of Care DRUG

Standard of Care

Standard of Care; Supplemental Treatment

Ranibizumab DRUG

Injection

Also known as: LUCENTIS

Supplemental Treatment

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Must provide written, signed informed consent for this study.
• Must have been enrolled in a previous clinical study of ABBV-RGX-314 in the treatment of nAMD 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.

You may not qualify if:

• \. None

Sponsors & Collaborators

• AbbVie: lead
• REGENXBIO Inc.: collaborator

Study Sites (16)

Retinal Research Institute, LLC

Phoenix, Arizona, 85014, United States

Location

California Retina Consultants

Bakersfield, California, 93309, United States

Location

Retina-Vitreous Associates Medical Group

Beverly Hills, California, 90211, United States

Location

Northern California Retina Vitreous Associates Medical Group Inc

Mountain View, California, 94040, United States

Location

Retina Consultants San Diego

Poway, California, 92064, United States

Location

California Retina Consultants

Santa Barbara, California, 93103, United States

Location

Southeast Retina Center PC

Augusta, Georgia, 30909, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

Vitreoretinal Surgery PLLC

Edina, Minnesota, 55435, United States

Location

Sierra eye Associates

Reno, Nevada, 89502, United States

Location

Vision Research Center Eye Associates of New Mexico

Albuquerque, New Mexico, 87109, United States

Location

Retinovitreous Associates, LTD

Philadelphia, Pennsylvania, 19107, United States

Location

Charles Retina Institute, P.C

Germantown, Tennessee, 38138, United States

Location

Tennessee Retina, PC

Nashville, Tennessee, 37203, United States

Location

Retina Consultants of Texas

The Woodlands, Texas, 77384, United States

Location

MeSH Terms

Interventions

Standard of Care; Ranibizumab

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2022
• First Posted: January 27, 2022
• Study Start: December 20, 2021
• Primary Completion (Estimated): July 1, 2031
• Study Completion (Estimated): July 1, 2031
• Last Updated: August 5, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: For details on when studies are available for sharing, visit https://vivli.org/ourmember/abbvie/
• Access Criteria: To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

Locations

US (16)