NCT05930561

4D-150 in Patients With Diabetic Macular Edema

A Phase 2 Randomized, Active-Controlled, Double-masked Trial of Intravitreal 4D-150 Gene Therapy in Adults With Diabetic Macular Edema (SPECTRA)

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: 4D Molecular Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This Phase 2 trial is a prospective, multicenter, randomized, active-controlled, double-masked dose-ranging trial to evaluate the safety and efficacy of 4D-150 in adults with DME. The trial will be conducted in two parts: Dose Confirmation and Dose Expansion.

Conditions

• Diabetic Macular Edema
• Diabetic Retinopathy

Interventions

Type	Name	Description
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

Timeline

• Start date: 2023-08-09
• Primary completion: 2029-02-28
• Completion: 2029-02-28
• First posted: 2023-07-05
• Last updated: 2025-09-22

Locations

6 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study