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Phase 2 Trial of RGX-314 in Adults With Center Involved - Diabetic Macular Edema (CI - DME)

NCT06942520 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 18

Last updated 2025-04-24

No results posted yet for this study

Summary

Phase 2 open label, randomized, active controlled, dose-ranging trial in adults with Center Involved - Diabetic Macular Edema (CI - DME)

Conditions

Interventions

GENETIC

RGX-314 Dose 1

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

GENETIC

RGX-314 Dose 2

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

BIOLOGICAL

Aflibercept (2.0 mg)

Commercially available Active Comparator

Sponsors & Collaborators

  • REGENXBIO Inc.

    collaborator INDUSTRY

  • Sierra Eye Associates

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2025-03-18
Primary Completion
2027-12-31
Completion
2027-12-31
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases
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 NCT06942520 on ClinicalTrials.gov