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Study of CU06-1004 in Patients With Daibetic Macular Edema

NCT07459829 · Status: NOT_YET_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 156

Last updated 2026-03-10

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Curacle Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-12-01
Primary Completion
2028-01-01
Completion
2028-01-30
FDA Drug
Yes

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Entities

Diseases

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 NCT07459829 on ClinicalTrials.gov