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RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Neovascular Age-Related Macular Degeneration (nAMD)

NCT04514653 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2026-02-27

No results posted yet for this study

Summary

This interventional study is being conducted with an investigational gene therapy treatment called ABBV-RGX-314 (also known as RGX-314) and is being developed as a potential one-time gene therapy treatment for neovascular (wet) age-related macular degeneration (wet AMD or nAMD). The typical treatment for nAMD is frequent injections of anti-VEGF therapy. Researchers are testing ABBV-RGX-314 to see if it has similar effects as the current approved standard of care, such as Lucentis® or Eylea® injections.

The duration of this study will be up to 52 weeks or for ranibizumab control participants who cross over to ABBV-RGX-314 after week 52, up to 80 weeks post-randomization.

The primary outcome measure for this investigational study is to evaluate the mean change in best-corrected visual acuity (BCVA) for ABBV-RGX-314 compared with ranibizumab monthly at the Week 40 visit.

Conditions

  • Neovascular Age-Related Macular Degeneration (nAMD)

Interventions

BIOLOGICAL

Ranibizumab

Ranibizumab (anti-VEGF agent)

GENETIC

ABBV-RGX-314 Dose 1

AAV8 vector containing a transgene for anti-VEGF fab (Dose 1)

GENETIC

ABBV-RGX-314 Dose 2

AAV8 vector containing a transgene for anti-VEGF fab (Dose 2)

GENETIC

ABBV-RGX-314 Dose 3

AAV8 vector containing a transgene for anti-VEGF fab (Dose 3)

DRUG

Local Steroid

Local steroid

DRUG

Topical Steroid

Topical steroid

GENETIC

ABBV-RGX-314 Dose 4

AAV8 vector containing a transgene for anti-VEGF fab (Dose 4)

Sponsors & Collaborators

Principal Investigators

  • ABBVIE INC. · AbbVie

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
50 Years
Max Age
89 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-08-25
Primary Completion
2026-08-31
Completion
2027-02-28
FDA Drug
Yes
FDA Device
Yes

Countries

  • United States

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04514653 on ClinicalTrials.gov