4D-150 in Patients With Diabetic Macular Edema

NCT05930561 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 72

Last updated 2025-09-22

No results posted yet for this study

Summary

Phase 2 randomized, active-controlled, double-masked, dose-ranging trial in adults with Diabetic Macular Edema (DME).

Conditions

Interventions

BIOLOGICAL

4D-150 IVT

4D-150: AAV-based gene therapy comprised of miRNA targeting VEGF-C and codon-optimized sequence encoding aflibercept.

BIOLOGICAL

Aflibercept IVT

Commercially available Active Comparator

Sponsors & Collaborators

  • 4D Molecular Therapeutics

    lead INDUSTRY

Principal Investigators

  • Julie Clark, MD · 4D Molecular Therapeutics

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-08-09
Primary Completion
2029-02-28
Completion
2029-02-28
FDA Drug
Yes

Countries

  • United States
  • Puerto Rico

Study Locations

More Related Trials

Entities

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 NCT05930561 on ClinicalTrials.gov