CU06-1004 for Diabetic Macular Edema

No longer 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests an experimental pill called CU06-1004 to evaluate its effectiveness and safety in treating diabetic macular edema (DME), a condition where fluid accumulates in the eye, impairing vision. Participants will be divided into three groups to receive different doses of the medication for 12 weeks. The trial seeks adults with diabetes who experience DME and noticeable retinal swelling that impacts daily life. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, providing participants an opportunity to contribute to significant advancements in DME treatment.

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.

Is there any evidence suggesting that CU06-1004 is likely to be safe for humans?

Research shows that CU06-1004 is generally safe for people. Studies have found it well-tolerated, with no serious drug-related side effects reported. In early tests, participants who took different doses of CU06-1004 experienced no major safety issues. This suggests that, based on current data, the treatment is safe for humans. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for diabetic macular edema?

Researchers are excited about CU06-1004 for diabetic macular edema because it introduces a potentially new mechanism of action compared to current treatments like anti-VEGF injections. Unlike these standard treatments, which primarily target blood vessel growth in the eye, CU06-1004 is a pill taken orally, which could offer a more convenient alternative for patients. Additionally, this oral administration might help reduce the need for frequent eye injections, which can be uncomfortable and challenging for many patients. The different dosing options—100 mg, 200 mg, and 300 mg—allow researchers to explore the optimal balance of effectiveness and safety.

What evidence suggests that CU06-1004 might be an effective treatment for diabetic macular edema?

Research has shown that CU06-1004 may help treat diabetic macular edema (DME). Studies have found that this oral treatment can improve vision clarity and positively affect the eyes of people with DME. CU06-1004 works by preventing fluid from leaking out of blood vessels and maintaining their stability. It also helps stop the growth of new, leaky blood vessels that can worsen DME. These findings suggest that CU06-1004 could effectively reduce eye swelling and improve vision in people with DME. Participants in this trial will receive different dosages of CU06-1004 to evaluate its effectiveness and safety. ^{1 2 3 4 5}

Who Is on the Research Team?

Pankyung Kim, M.S

Principal Investigator

Curacle Co., Ltd.

Are You a Good Fit for This Trial?

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

Subject who has total bilirubin > 1.5 × ULN

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT05573100

NCT05573100 | The Study of CU06-1004 in Patients With ... 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 ...

2. hcplive.com hcplive.com/view/cu06-shows-potential-oral-therapy-diabetic-macular-edema

CU06 Shows Potential as Oral Therapy for Diabetic ... Oral CU06-1004 was linked to improvements in best-corrected visual acuity (BCVA) and positive anatomic changes in eyes with diabetic macular edema (DME).

3. iovs.arvojournals.org iovs.arvojournals.org/article.aspx?articleid=2794235

First in human, phase 1 study of CU06-1004, an oral vascular ... CU06-1004 (CU06) is a novel, orally administered vascular leakage blocker that was confirmed to inhibit angiogenesis and stabilize vessels.

4. sciencedirect.com sciencedirect.com/science/article/pii/S0014299922006884

Oral administration of CU06-1004 attenuates vascular ... We were able to confirm that oral administration of CU06-1004, an endothelial dysfunction blocker, inhibited retinal vascular leakage.

5. withpower.com withpower.com/trial/phase-2-edema-9-2022-bc8f7

CU06-1004 for Diabetic Macular Edema · Info for Participants 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.