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Gene Therapy

RGX-314 Gene Therapy for Age-Related Macular Degeneration (AAVIATE Trial)

Phase 2
Recruiting
Research Sponsored by REGENXBIO, Inc.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 52 weeks
Awards & highlights
No Placebo-Only Group

Summary

This trial is evaluating a potential new treatment for a disease that causes vision loss. The current standard of care for this disease requires life-long, repeated injections to maintain efficacy, but this new treatment would only require a single injection.

Who is the study for?
This trial is for people aged 50 to 89 with neovascular age-related macular degeneration (wet AMD) in one eye. They must have had a positive response to previous anti-VEGF therapy and be willing to consent to the study.
What is being tested?
The trial tests RGX-314, a potential one-time gene therapy for wet AMD. It's compared against standard treatments like Ranibizumab. Participants will receive different doses of RGX-314 or local/topical steroids.
What are the potential side effects?
Possible side effects include inflammation of the eye (choroidal effusion), discomfort at the injection site, and typical risks associated with steroid use such as increased pressure inside the eye.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Ranibizumab
Secondary study objectives
Assess the need for supplemental anti-vascular endothelial growth factor (VEGF) therapy in participants who receive RGX-314 treatment
Evaluate the concentration of RGX-314 transgene product (TP) in aqueous humor and serum
Evaluate the effect of RGX-314 on BCVA
+4 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

6Treatment groups
Experimental Treatment
Active Control
Group I: RGX-314 Treatment Arm (Dose 3) and Topical SteroidExperimental Treatment2 Interventions
RGX-314 Dose 3 and Topical Steroid
Group II: RGX-314 Treatment Arm (Dose 3) and Local SteroidExperimental Treatment2 Interventions
RGX-314 Dose 3 and Local Steroid
Group III: RGX-314 Treatment Arm (Dose 3)Experimental Treatment1 Intervention
RGX-314 Dose 3
Group IV: RGX-314 Treatment Arm (Dose 2)Experimental Treatment1 Intervention
RGX-314 Dose 2
Group V: RGX-314 Treatment Arm (Dose 1)Experimental Treatment1 Intervention
RGX-314 Dose 1
Group VI: Ranibizumab controlActive Control1 Intervention
Control treatment arm

Find a Location

Who is running the clinical trial?

REGENXBIO, Inc.Lead Sponsor
19 Previous Clinical Trials
2,373 Total Patients Enrolled
Regenxbio Inc.Lead Sponsor
19 Previous Clinical Trials
2,373 Total Patients Enrolled
REGENXBIO Inc.Lead Sponsor
24 Previous Clinical Trials
2,630 Total Patients Enrolled

Media Library

RGX-314 (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04514653 — Phase 2
Age-Related Macular Degeneration Research Study Groups: Ranibizumab control, RGX-314 Treatment Arm (Dose 1), RGX-314 Treatment Arm (Dose 2), RGX-314 Treatment Arm (Dose 3), RGX-314 Treatment Arm (Dose 3) and Local Steroid, RGX-314 Treatment Arm (Dose 3) and Topical Steroid
Age-Related Macular Degeneration Clinical Trial 2023: RGX-314 Highlights & Side Effects. Trial Name: NCT04514653 — Phase 2
RGX-314 (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04514653 — Phase 2
~19 spots leftby Oct 2025
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