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

NCT05573100 | Completed Phase 2 FDA Drug

• 1 other identifier: CU06-RE-P2A-01
• Study Type: interventional
• Target: 67
• Locations: 2 countries
• Sites: 11

Brief 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

Keywords

DME; Endothelial dysfunction blocker

Outcome Measures

Primary Outcomes (2)

• The change of central subfield thickness (CST)

  Change in CST in the study eye assessed by SD-OCT at Week 12 compared to baseline

  Baseline and 12 weeks

• To determine the optimal doses

  The 1:1:1 randomization is fitting for the study objective to determine the optimal doses for a phase 2b study.

  12 weeks

Secondary Outcomes (6)

• The change of central subfield thickness (CST)

  Baseline, 4 weeks and 8 weeks

• The change of all other subfield thickness

  Baseline, 4 weeks, 8 weeks and 12 weeks

• The change of early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) letter score

  Baseline, 4 weeks, 8 weeks and 12 weeks

• Change in diabetic retinopathy severity scale (DRSS)

  Baseline and 12 weeks

• The change of blood biomarkers

  Baseline and 12 weeks

Study Arms (3)

CU06-1004 100mg

EXPERIMENTAL

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

Drug: CU06-1004

CU06-1004 200mg

EXPERIMENTAL

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

Drug: CU06-1004

CU06-1004 300mg

EXPERIMENTAL

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

Drug: CU06-1004

Interventions

CU06-1004 DRUG

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.

Also known as: SAC-1004, CU06, CU06-RE

CU06-1004 100mg; CU06-1004 200mg; CU06-1004 300mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subject who is male or female ≥ 18 years of age
• Subject who has a diagnosis of Type 1 or 2 diabetes mellitus
• Subject who has study eye with definite retinal thickening due to diabetic macular edema involving the center of the macula
• Subject who has voluntarily signed an informed consent form
• Subject who has study eye with central subfield thickness (CST) of the following on SD-optical coherence tomography (OCT).
• Zeiss Cirrus: CST ≥ 290 µm in women, or ≥ 305 µm in men
• Heidelberg Spectralis: CST ≥ 305 µm in women, or ≥ 320 µm in men
• Subject who has DRSS score ≥ 35
• 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 media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.

You may not qualify if:

• Subject whose macular edema is of non-diabetic retinopathy etiology (e.g., secondary to vitreomacular interface abnormalities).
• Subject who has had major surgery within 3 months prior to randomization or major surgery planned during the next 6 months.
• Subject who has a hypersensitivity to any excipients of the investigational product or similar class of drug and ingredient.
• Subject who has the following illness or abnormal laboratory test values:
• Uncontrolled hypertension (SBP \> 180 mmHg or DBP \> 100 mmHg)
• Uncontrolled diabetes (HbA1c \> 12.0%)
• Total bilirubin \> 1.5 × ULN
• Positive results for HIV or Hepatitis B or C viruses
• Other clinically significant abnormal lab values per Investigator's judgement
• Subject who participated in an investigational trial of biologic agent within 3 months and any other investigational trial within 1 month of randomization.
• Subject who has received gene therapy for any indication.
• Subject who has received COVID-19 vaccine within 30 days of first dosing until the end of the study.
• Pregnant woman, lactating woman, or female or male subject of childbearing potential who doesn't accept appropriate contraceptive measures for the next 6 months
• \* Hormonal contraceptives, intrauterine contraceptive device, sterilization of spouse (e.g., vasectomy, tubal ligation), double-barrier method (e.g., combinational use of spermicides and condoms, diaphragm, contraceptive sponge, or FemCap)
• Subject who has medical condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure, cardiovascular disease, and glycemic control).

Sponsors & Collaborators

• Curacle Co., Ltd.: lead
• Théa Open Innovation, France: collaborator

Study Sites (11)

Rand Eye Institute

Deerfield Beach, Florida, 33064, United States

Location

Elman Retina Group

Baltimore, Maryland, 21237, United States

Location

Cumberland Valley Retina Consultants

Hagerstown, Maryland, 21740, United States

Location

Ophthalmic Consultants of Boston

Boston, Massachusetts, 02114, United States

Location

New England Retina Consultants

Springfield, Massachusetts, 01107, United States

Location

Mid Atlantic Retina

Bethlehem, Pennsylvania, 18017, United States

Location

Austin Research Center for Retina

Austin, Texas, 78705, United States

Location

Retina consultant of Texas

Bellaire, Texas, 77339, United States

Location

Valley Retina Institute

McAllen, Texas, 78503, United States

Location

Wagner Macula and Retina Center

Norfolk, Virginia, 23454, United States

Location

Emanuelli Research & Development Center

Arecibo, 00612, Puerto Rico

Location

MeSH Terms

Interventions

CU06-1004

Study Officials

• Pankyung Kim, M.S

  Curacle Co., Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2022
• First Posted: October 10, 2022
• Study Start: December 21, 2022
• Primary Completion: May 31, 2023
• Study Completion: June 30, 2023
• Last Updated: May 3, 2024

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (10); PR (1)