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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05573100
Other study ID # CU06-RE-P2A-01
Secondary ID
Status Completed
Phase Phase 2
First received
Last updated
Start date December 21, 2022
Est. completion date June 30, 2023

Study information

Verified date July 2023
Source Curacle Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


Recruitment information / eligibility

Status Completed
Enrollment 67
Est. completion date June 30, 2023
Est. primary completion date May 31, 2023
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 central subfield thickness (CST) of the following on SD-optical coherence tomography (OCT). 1. Zeiss Cirrus: CST = 290 µm in women, or = 305 µm in men 2. Heidelberg Spectralis: CST = 305 µm in women, or = 320 µm in men 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 of biologic agent within 3 months and any other investigational trial within 1 month of randomization. 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, 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. 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
CU06-1004
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.

Locations

Country Name City State
Puerto Rico Emanuelli Research & Development Center Arecibo
United States Austin Research Center for Retina Austin Texas
United States Elman Retina Group Baltimore Maryland
United States Retina consultant of Texas Bellaire Texas
United States Mid Atlantic Retina Bethlehem Pennsylvania
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States Rand Eye Institute Deerfield Beach Florida
United States Cumberland Valley Retina Consultants Hagerstown Maryland
United States Valley Retina Institute McAllen Texas
United States Wagner Macula and Retina Center Norfolk Virginia
United States New England Retina Consultants Springfield Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Curacle Co., Ltd. Théa Open Innovation, France

Countries where clinical trial is conducted

United States,  Puerto Rico, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
Primary 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 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 Baseline, 4 weeks and 8 weeks
Secondary 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 Baseline, 4 weeks, 8 weeks and 12 weeks
Secondary 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 Baseline, 4 weeks, 8 weeks and 12 weeks
Secondary Change in diabetic retinopathy severity scale (DRSS) Change in DRSS in the study eye at Weeks 12 compared to baseline Baseline and 12 weeks
Secondary The change of blood biomarkers Change in blood biomarker (TNF-alpha, IL-1 beta, IL-6) at Week 12 compared to baseline Baseline and 12 weeks
Secondary Number and severity of treatment emergent adverse events (TEAEs) Number and severity of TEAEs up to Week 12 compared to baseline Baseline and 12 weeks
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