NCT07459829

Study of CU06-1004 in Patients With Daibetic Macular Edema

A Phase 2b, Randomized, Double-masked, Parallel-group, Multi-center Study to Evaluate the Efficacy and Safety of CU06-1004 for 24 Weeks in Patients With Center-Involved Diabetic Macular Edema (DME)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 156 (estimated)
• Sponsor: Curacle Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2b trial is a randomized, double-masked, parallel-group, multi-center study in approximately 156 patients with DME to evaluate the efficacy and safety of CU06-1004 orally administered once daily for 24 weeks. The study will have a 1:1:1 randomization (CU06-1004 200mg: CU06-1004 300mg: Placebo).

Conditions

• DME
• Diabetic Macular Edema
• Diabetic Macular Edema (DME)

Interventions

Type	Name	Description
DRUG	CU06-1004	CU06-1004 is an oral capsule. At room temperature, it appears as a white to off-white powder. The 100 mg soft gelatin capsules contain a solution-based fill.
DRUG	Placebo Control	A matching placebo capsule administered orally

Timeline

• Start date: 2026-12-01
• Primary completion: 2028-01-01
• Completion: 2028-01-30
• First posted: 2026-03-10
• Last updated: 2026-03-10

Regulatory

• FDA-regulated drug study