RGX-314 Dose 2 for Diabetic Retinopathy

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Diabetic RetinopathyRGX-314 Dose 2 - Genetic
Eligibility
25 - 89
All Sexes
What conditions do you have?
Select

Study 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.

Eligible Conditions
  • Diabetic Retinopathy

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: 48 weeks

48 weeks
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 effect of RGX-314 on DR by the Early Treatment Diabetic Retinopathy Study (ETDRS)-Diabetic Retinopathy Severity Scale (-DRSS) at week 48
To evaluate the incidences of ocular inflammation following SCS RGX-314 administration
To evaluate the need for additional Standard of Care (SOC) intervention due to ocular diabetic complications
Complications of Diabetes Mellitus

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

4 Treatment Groups

Observation Control Arm
1 of 4
RGX-314 Treatment Arm (Dose 3) and Topical Steroid
1 of 4
RGX-314 Treatment Arm (Dose 2)
1 of 4
RGX-314 Treatment Arm (Dose 1)
1 of 4

Active Control

Experimental Treatment

100 Total Participants · 4 Treatment Groups

Primary Treatment: RGX-314 Dose 2 · No Placebo Group · Phase 2

RGX-314 Treatment Arm (Dose 3) and Topical SteroidExperimental Group · 2 Interventions: RGX-314 Dose 3, Topical Steroid · Intervention Types: Genetic, Drug
RGX-314 Treatment Arm (Dose 2)
Genetic
Experimental Group · 1 Intervention: RGX-314 Dose 2 · Intervention Types: Genetic
RGX-314 Treatment Arm (Dose 1)
Genetic
Experimental Group · 1 Intervention: RGX-314 Dose 1 · Intervention Types: Genetic
Observation Control ArmNoIntervention Group · 1 Intervention: Observation Control Arm · Intervention Types:

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: 48 weeks

Who is running the clinical trial?

REGENXBIO, Inc.Lead Sponsor
19 Previous Clinical Trials
1,310 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
60 Patients Enrolled for Diabetic Retinopathy
Regenxbio Inc.Lead Sponsor
19 Previous Clinical Trials
1,310 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
60 Patients Enrolled for Diabetic Retinopathy
AbbVieIndustry Sponsor
835 Previous Clinical Trials
471,320 Total Patients Enrolled
REGENXBIO Inc.Lead Sponsor
21 Previous Clinical Trials
1,528 Total Patients Enrolled
1 Trials studying Diabetic Retinopathy
60 Patients Enrolled for Diabetic Retinopathy

Eligibility Criteria

Age 25 - 89 · All Participants · 4 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are 25 to 89 years of age with a diagnosis of NPDR or PDR secondary to diabetes mellitus Type 1 or 2 for which PRP or anti-VEGF injections can be safely deferred for at least 6 months.
The patient must have a BCVA of at least 69 letters (approximate Snellen equivalent of 20/40 or better) in the study eye.
Prior history of CI-DME in the study eye is acceptable.
You must be willing and able to provide written, signed informed consent.