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Gene Therapy

RGX-314 Gene Therapy for Diabetic Retinopathy (ALTITUDE 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 48 weeks
Awards & highlights

ALTITUDE Trial Summary

This trial is testing a new gene therapy treatment for diabetic retinopathy, a progressive complication of diabetes that is a leading cause of vision loss. The new treatment is being developed as a potential one-time treatment that may provide a longer duration of therapeutic effect and intervene at an earlier stage of the disease.

Who is the study for?
This trial is for adults aged 25-89 with diabetic retinopathy, who have good vision (20/40 or better) and can delay other treatments like PRP or anti-VEGF injections for at least 6 months. It's not for those with active macular edema, prior eye surgeries, potential pregnancy, or retinal issues not caused by diabetes.Check my eligibility
What is being tested?
The study tests RGX-314 gene therapy as a one-time treatment for diabetic retinopathy. Participants will receive different doses of RGX-314 administered into the suprachoroidal space of the eye to see if it can improve their condition without frequent treatments.See study design
What are the potential side effects?
Potential side effects may include discomfort in the eye where RGX-314 is injected, increased pressure inside the eye, inflammation, bleeding complications and possible impact on vision. A topical steroid might be used to manage some side effects.

ALTITUDE Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~48 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 48 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
To evaluate the effect of RGX-314 on DR by the Early Treatment Diabetic Retinopathy Study (ETDRS)-Diabetic Retinopathy Severity Scale (-DRSS) at week 48
Secondary outcome measures
To assess the safety and tolerability of RGX-314
To evaluate the effect of RGX-314 on DR (ETDRS-DRSS) over time
To evaluate the incidences of ocular inflammation following SCS RGX-314 administration
+1 more

ALTITUDE Trial Design

4Treatment 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 2)Experimental Treatment1 Intervention
RGX-314 Dose 2
Group III: RGX-314 Treatment Arm (Dose 1)Experimental Treatment1 Intervention
RGX-314 Dose 1
Group IV: Observation Control ArmActive Control1 Intervention
Observation Control

Find a Location

Who is running the clinical trial?

REGENXBIO, Inc.Lead Sponsor
19 Previous Clinical Trials
2,193 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
100 Patients Enrolled for Diabetic Retinopathy
Regenxbio Inc.Lead Sponsor
19 Previous Clinical Trials
2,193 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
100 Patients Enrolled for Diabetic Retinopathy
REGENXBIO Inc.Lead Sponsor
23 Previous Clinical Trials
2,435 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
100 Patients Enrolled for Diabetic Retinopathy

Media Library

RGX-314 (Gene Therapy) Clinical Trial Eligibility Overview. Trial Name: NCT04567550 — Phase 2
Diabetic Retinopathy Research Study Groups: Observation Control Arm, RGX-314 Treatment Arm (Dose 1), RGX-314 Treatment Arm (Dose 2), RGX-314 Treatment Arm (Dose 3) and Topical Steroid
Diabetic Retinopathy Clinical Trial 2023: RGX-314 Highlights & Side Effects. Trial Name: NCT04567550 — Phase 2
RGX-314 (Gene Therapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04567550 — Phase 2
Diabetic Retinopathy Patient Testimony for trial: Trial Name: NCT04567550 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

For patients that are octogenarians, is it possible to enroll in this research study?

"The primary target recruitment pool for this study are patients that fall between 25 and 89 years old."

Answered by AI

Might I be eligible to experience this trial's benefits first-hand?

"Sixty individuals with retinal diseases will be observed in this clinical trial. Patients must meet the following age, visual acuity, and treatment history requirements: 25-89 years old with a diabetic retinopathy diagnosis of nonproliferative diabetic retinopathy (NPDR) or proliferative diabetic retinopathy (PDR), BCVA Early Treatment Diabetic Retinopathy Study (ETDRS) letter score ≥69 letters (approximate Snellen equivalent of 20/40 or better), prior history of CI-DME in the study eye is acceptable, willing and able to provide written informed consent."

Answered by AI

Are patients currently being enrolled in this experiment?

"This study, according to the latest information available on clinicaltrials.gov, is not currently looking for participants. Although this may be the case, there are 191 other trials that patients might be eligible for."

Answered by AI

Can you give me an idea of the scope of this trial's hospitals?

"There are a total of 21 research sites for this study which can be found in Hagerstown, Albuquerque, Boston, and 18 other locations."

Answered by AI

What is the legal status of RGX-314 Dose 2 in the United States?

"While Phase 2 trials lack the efficacy data of later stages, our team believes that RGX-314 Dose 2 can be considered a safe medication."

Answered by AI

Who else is applying?

What state do they live in?
New York
Louisiana
Texas
What site did they apply to?
Woodlands Location
Austin Location
Wilmer Eye Institute/Johns Hopkins University School of Medicine
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1
3+
0

Why did patients apply to this trial?

I don't want to be blind. Im hoping this clinical trial can help me. I am completely blind in right eye so I was wondering if your trial would help.
PatientReceived 2+ prior treatments
I have diabetic renothany for about eight years and like to explore better or more options.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) Without Center Involved-Diabetic Macular Edema (CI-DME)
2020. "RGX-314 Gene Therapy Administered in the Suprachoroidal Space for Participants With Diabetic Retinopathy (DR) Without Center Involved-Diabetic Macular Edema (CI-DME)". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04567550.
All > Diabetic Retinopathy
~0 spots leftby May 2024
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