CU06-1004 for Diabetic Macular Edema

Recruiting at 13 trial locations

Overseen By Heewon Seo, M.S

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Curacle Co., Ltd.

Must not be taking: Anti-VEGF, Vaccinium myrtillus

Disqualifiers: Uncontrolled hypertension, Uncontrolled diabetes, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 4

Duration: 12 weeks

67 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests an oral medication called CU06-1004 on patients with Diabetic Macular Edema to see if it can reduce eye swelling and improve vision.

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. However, you cannot have taken vaccinium myrtillus extract or dobesilate calcium within 2 weeks before joining the trial.

Research Team

Pankyung Kim, M.S

Principal Investigator

Curacle Co., Ltd.

Eligibility Criteria

This trial is for adults over 18 with Type 1 or Type 2 diabetes who have swelling in the retina due to diabetic macular edema. Participants must have certain levels of retinal thickness and vision range, and be able to undergo eye photography. Exclusions include recent cardiovascular events, certain past treatments like intravitreal injections, uncontrolled health conditions, pregnancy, or not using contraception.

Inclusion Criteria

Subject who has study eye with an ETDRS BCVA letter score ranging from 34 to 83, inclusive (approximate Snellen equivalent of 20/25 - 20/200 at a distance of 4 meters)

Subject who has voluntarily signed an informed consent form

I have been diagnosed with Type 1 or Type 2 diabetes.

Exclusion Criteria

Subject who has a hypersensitivity to any excipients of the investigational product or similar class of drug and ingredient

Subject who has other clinically significant abnormal lab values per Investigator's judgement

My macular edema is not caused by diabetes.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive CU06-1004 orally once daily for 12 weeks with a 1:1:1 randomization to different dosages

12 weeks

Visits at baseline, 4 weeks, 8 weeks, and 12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• CU06-1004

Trial Overview The study tests CU06-1004's effectiveness and safety in treating diabetic macular edema when taken orally once a day for 12 weeks. There are three different dosage groups (100mg, 200mg, and 300mg), with patients randomly assigned to one of these groups in equal numbers.

Participant Groups

Group I: CU06-1004 300mg Experimental Treatment 1 Intervention

CU06-1004 100 mg tablets. Dosed at 300 mg (3 capsules) QD within 30 minutes after meal on each evening

Group II: CU06-1004 200mg Experimental Treatment 1 Intervention

CU06-1004 100 mg tablets. Dosed at 200 mg (2 capsules) QD within 30 minutes after meal on each evening

Group III: CU06-1004 100mg Experimental Treatment 1 Intervention

CU06-1004 100 mg tablets. Dosed at 100 mg (1 capsule) QD within 30 minutes after meal on each evening

Who Is Running the Clinical Trial?

Curacle Co., Ltd.

Lead Sponsor

Trials

4

Recruited

430+

Laboratorios Thea, France

Collaborator

Trials

1

Recruited

70+

Laboratoires Thea, France

Collaborator

Trials

1

Recruited

70+

Théa Open Innovation, France

Collaborator

Trials

1

Recruited

70+

Laboratorios Thea, Spain

Industry Sponsor

Trials

4

Recruited

290+