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

Primary Purpose

Diabetic Macular Edema

Status
Active
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CU06-1004
Sponsored by
Curacle Co., Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring DME, Endothelial dysfunction blocker

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Subject who is male or female ≥ 18 years of age
  2. Subject who has a diagnosis of Type 1 or 2 diabetes mellitus
  3. Subject who has study eye with definite retinal thickening due to diabetic macular edema involving the center of the macula
  4. Subject who has voluntarily signed an informed consent form
  5. Subject who has study eye with CST of ≥ 320μm on SD-OCT
  6. Subject who has DRSS score ≥ 35
  7. 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).
  8. Subject who has media clarity, pupillary dilation, and subject cooperation sufficient for adequate fundus photographs.

Exclusion Criteria:

  1. Subject whose macular edema is of non-diabetic retinopathy etiology (e.g., secondary to vitreomacular interface abnormalities).
  2. Subject who has had major surgery within 3 months prior to randomization or major surgery planned during the next 6 months.
  3. Subject who has a hypersensitivity to any excipients of the investigational product or similar class of drug and ingredient.
  4. 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
  5. Subject who participated in an investigational trial within 3 months of randomization that involved treatment with any drug that has not received regulatory approval at the time of study entry.
  6. Subject who has received gene therapy for any indication.
  7. Subject who has received COVID-19 vaccine within 30 days of first dosing until the end of the study.
  8. 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)

  9. 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).
  10. Subject who administered vaccinium myrtillus extract or dobesilate calcium within 2 weeks before randomization.
  11. Subject who has unstable angina, myocardial infarction, transient ischemic attack, cerebral infarction, coronary artery bypass surgery, or transluminal coronary angioplasty within 6 months before screening.
  12. Subject who has an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition etc.).
  13. Subject who has exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis.
  14. Subject who is expected to have no improvement of decreased visual acuity in the opinion of the Investigator, even if macular edema is resolved (e.g., foveal atrophy, abnormal pigmentation, dense subfoveal hard exudate).
  15. Subject who has a history of treatment with anti-VEGF agents, focal laser treatment (Focal/grid laser photocoagulation), or any other treatment within 3 months prior to study entry or intravitreal dexamethasone or triamcinolone within 6 months prior to study entry.
  16. Subject who has a history of treatment with intravitreal fluocinolone astonide.
  17. Subject who has a history of panretinal scatter photocoagulation (PRP).
  18. Subject who anticipated need for PRP in the 3 months following randomization.
  19. Subject who has a history of ocular surgery (including cataract extraction, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following randomization.
  20. Subject who has a history of retinal detachment or retinal detachment repair surgery.
  21. Subject who has a history of YAG capsulotomy performed within 2 months prior to randomization.
  22. Subject who has uncontrolled glaucoma in either eye (intraocular pressure (IOP) > 24 mmHg on medication or according to the investigator's judgment).
  23. Subject who has a history of vitrectomy.
  24. Subject who has any active intraocular inflammatory diseases such as uveitis, conjunctivitis, and in either eye.
  25. Subject who has any history of intraocular inflammation in either eye other than what would be expected in the normal post-operative course following prior routine ocular surgery such as cataract surgery.

Sites / Locations

  • Rand Eye Institute
  • Elman Retina Group
  • Cumberland Valley Retina Consultants
  • Ophthalmic Consultants of Boston
  • New England Retina Consultants
  • Mid Atlantic Retina
  • Austin Research Center for Retina
  • Retina consultant of Texas
  • Valley Retina Institute
  • Wagner Macula and Retina Center
  • Emanuelli Research & Development Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Experimental

Arm Label

CU06-1004 100mg

CU06-1004 200mg

CU06-1004 300mg

Arm Description

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

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

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

Outcomes

Primary Outcome Measures

The change of central subfield thickness (CST)
Change in CST in the study eye assessed by SD-OCT at Week 12 compared to baseline
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.

Secondary Outcome Measures

The change of central subfield thickness (CST)
Change in CST in the study eye assessed by SD-OCT Weeks 4 and 8 compared to baseline
The change of all other subfield thickness
Change in all other subfield thickness (Nasal, temporal, superior and inferior) in the study eye assessed by SD-OCT at Weeks 4, 8, and 12 compared to baseline
The change of early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) letter score
Change in ETDRS BCVA letter score in the study eye at Weeks 4, 8, and 12 compared to baseline
Change in diabetic retinopathy severity scale (DRSS)
Change in DRSS in the study eye at Weeks 12 compared to baseline
The change of blood biomarkers
Change in blood biomarker (TNF-alpha, IL-1 beta, IL-6) at Week 12 compared to baseline
Number and severity of treatment emergent adverse events (TEAEs)
Number and severity of TEAEs up to Week 12 compared to baseline

Full Information

First Posted
September 25, 2022
Last Updated
July 16, 2023
Sponsor
Curacle Co., Ltd.
Collaborators
Théa Open Innovation, France
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1. Study Identification

Unique Protocol Identification Number
NCT05573100
Brief Title
The Study of CU06-1004 in Patients With Diabetic Macular Edema (DME)
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
July 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
December 21, 2022 (Actual)
Primary Completion Date
February 29, 2024 (Anticipated)
Study Completion Date
March 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Curacle Co., Ltd.
Collaborators
Théa Open Innovation, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
DME, Endothelial dysfunction blocker

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CU06-1004 100mg
Arm Type
Experimental
Arm Description
CU06-1004 100 mg tablets. Dosed at 100 mg (1 capsule) QD within 30 minutes after meal on each evening
Arm Title
CU06-1004 200mg
Arm Type
Experimental
Arm Description
CU06-1004 100 mg tablets. Dosed at 200 mg (2 capsules) QD within 30 minutes after meal on each evening
Arm Title
CU06-1004 300mg
Arm Type
Experimental
Arm Description
CU06-1004 100 mg tablets. Dosed at 300 mg (3 capsules) QD within 30 minutes after meal on each evening
Intervention Type
Drug
Intervention Name(s)
CU06-1004
Other Intervention Name(s)
SAC-1004, CU06, CU06-RE
Intervention Description
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.
Primary Outcome Measure Information:
Title
The change of central subfield thickness (CST)
Description
Change in CST in the study eye assessed by SD-OCT at Week 12 compared to baseline
Time Frame
Baseline and 12 weeks
Title
To determine the optimal doses
Description
The 1:1:1 randomization is fitting for the study objective to determine the optimal doses for a phase 2b study.
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
The change of central subfield thickness (CST)
Description
Change in CST in the study eye assessed by SD-OCT Weeks 4 and 8 compared to baseline
Time Frame
Baseline, 4 weeks and 8 weeks
Title
The change of all other subfield thickness
Description
Change in all other subfield thickness (Nasal, temporal, superior and inferior) in the study eye assessed by SD-OCT at Weeks 4, 8, and 12 compared to baseline
Time Frame
Baseline, 4 weeks, 8 weeks and 12 weeks
Title
The change of early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) letter score
Description
Change in ETDRS BCVA letter score in the study eye at Weeks 4, 8, and 12 compared to baseline
Time Frame
Baseline, 4 weeks, 8 weeks and 12 weeks
Title
Change in diabetic retinopathy severity scale (DRSS)
Description
Change in DRSS in the study eye at Weeks 12 compared to baseline
Time Frame
Baseline and 12 weeks
Title
The change of blood biomarkers
Description
Change in blood biomarker (TNF-alpha, IL-1 beta, IL-6) at Week 12 compared to baseline
Time Frame
Baseline and 12 weeks
Title
Number and severity of treatment emergent adverse events (TEAEs)
Description
Number and severity of TEAEs up to Week 12 compared to baseline
Time Frame
Baseline and 12 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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). Subject who administered vaccinium myrtillus extract or dobesilate calcium within 2 weeks before randomization. Subject who has unstable angina, myocardial infarction, transient ischemic attack, cerebral infarction, coronary artery bypass surgery, or transluminal coronary angioplasty within 6 months before screening. Subject who has an ocular condition (other than diabetes) that, in the opinion of the investigator, might affect macular edema or alter visual acuity during the course of the study (e.g., vein occlusion, uveitis or other ocular inflammatory disease, neovascular glaucoma, Irvine-Gass Syndrome, foveal atrophy, pigmentary changes, dense subfoveal hard exudates, nonretinal condition etc.). Subject who has exam evidence of external ocular infection, including conjunctivitis, chalazion, or significant blepharitis. Subject who is expected to have no improvement of decreased visual acuity in the opinion of the Investigator, even if macular edema is resolved (e.g., foveal atrophy, abnormal pigmentation, dense subfoveal hard exudate). Subject who has a history of treatment with anti-VEGF agents, or focal laser treatment (Focal/grid laser photocoagulation) within 3 months prior to randomization or intravitreal dexamethasone or triamcinolone within 6 months prior to randomization. Subject who has a history of treatment with intravitreal fluocinolone astonide. Subject who has a history of panretinal scatter photocoagulation (PRP). Subject who anticipated need for PRP in the 3 months following randomization. Subject who has a history of ocular surgery (including cataract extraction, any intraocular surgery, etc.) within prior 3 months or anticipated within the next 6 months following randomization. Subject who has a history of retinal detachment or retinal detachment repair surgery. Subject who has a history of YAG capsulotomy performed within 2 months prior to randomization. Subject who has uncontrolled glaucoma in either eye (intraocular pressure (IOP) > 24 mmHg on medication or according to the investigator's judgment). Subject who has a history of vitrectomy. Subject who has any active intraocular inflammatory diseases such as uveitis, conjunctivitis, and in either eye. Subject who has any history of intraocular inflammation in either eye other than what would be expected in the normal post-operative course following prior routine ocular surgery such as cataract surgery.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pankyung Kim, M.S
Organizational Affiliation
Curacle Co., Ltd.
Official's Role
Study Director
Facility Information:
Facility Name
Rand Eye Institute
City
Deerfield Beach
State/Province
Florida
ZIP/Postal Code
33064
Country
United States
Facility Name
Elman Retina Group
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
Cumberland Valley Retina Consultants
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21740
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
New England Retina Consultants
City
Springfield
State/Province
Massachusetts
ZIP/Postal Code
01107
Country
United States
Facility Name
Mid Atlantic Retina
City
Bethlehem
State/Province
Pennsylvania
ZIP/Postal Code
18017
Country
United States
Facility Name
Austin Research Center for Retina
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Retina consultant of Texas
City
Bellaire
State/Province
Texas
ZIP/Postal Code
77339
Country
United States
Facility Name
Valley Retina Institute
City
McAllen
State/Province
Texas
ZIP/Postal Code
78503
Country
United States
Facility Name
Wagner Macula and Retina Center
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23454
Country
United States
Facility Name
Emanuelli Research & Development Center
City
Arecibo
ZIP/Postal Code
00612
Country
Puerto Rico

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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