NCT05573100

The Study of CU06-1004 in Patients With Diabetic Macular Edema (DME)

A Randomized, Open-label, Parallel-group, Multi-center Phase 2a Study to Evaluate the Efficacy and Safety of CU06-1004 for 12 Weeks in Patients With Diabetic Macular Edema (DME)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Curacle Co., Ltd. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This phase 2a trial is a randomized, open-label, parallel-group study in approximately 60 patients with DME to evaluate the efficacy and safety of CU06-1004 orally administered once daily for 12 weeks. The study will have a 1:1:1 randomization (CU06-1004 100mg: CU06-1004 200mg: CU06-1004 300mg).

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
DRUG	CU06-1004	CU06-1004 per capsule for oral administration. CU06-1004 is a white off powder at room temperature. The CU06-1004 100 mg soft gelatin capsules consist of a solution-based fill.

Timeline

• Start date: 2022-12-21
• Primary completion: 2023-05-31
• Completion: 2023-06-30
• First posted: 2022-10-10
• Last updated: 2024-05-03

Locations

11 sites across 2 countries: United States, Puerto Rico

Regulatory

• FDA-regulated drug study