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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
AAVIATE Trial 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.Check my eligibility
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.See study design
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.
AAVIATE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 52 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 weeks
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Ranibizumab
Secondary outcome measures
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 moreAAVIATE 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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Topical steroid
2020
Completed Phase 1
~140
Find a Location
Who is running the clinical trial?
REGENXBIO, Inc.Lead Sponsor
19 Previous Clinical Trials
2,178 Total Patients Enrolled
Regenxbio Inc.Lead Sponsor
19 Previous Clinical Trials
2,178 Total Patients Enrolled
REGENXBIO Inc.Lead Sponsor
23 Previous Clinical Trials
2,420 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You are between 50 and 89 years old.You have a vision condition called "age-related macular degeneration" that has led to abnormal blood vessels in your study eye.You are able to read and sign a document that explains the details of the study and agree to participate.You have previously received anti-VEGF therapy and it was effective in treating your condition.
Research Study Groups:
This trial has the following groups:- Group 1: Ranibizumab control
- Group 2: RGX-314 Treatment Arm (Dose 1)
- Group 3: RGX-314 Treatment Arm (Dose 2)
- Group 4: RGX-314 Treatment Arm (Dose 3)
- Group 5: RGX-314 Treatment Arm (Dose 3) and Local Steroid
- Group 6: RGX-314 Treatment Arm (Dose 3) and Topical Steroid
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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