Study of CU06-1004 in Patients With Daibetic Macular Edema

NCT07459829 | Not Yet Recruiting Phase 2 FDA Drug

• 1 other identifier: CU06-RE-P2B-01
• Study Type: interventional
• Target: 156
• Locations: 0 countries
• Sites: N/A

Brief Summary

This phase 2b trial is a randomized, double-masked, parallel-group, multi-center study in approximately 156 patients with DME to evaluate the efficacy and safety of CU06-1004 orally administered once daily for 24 weeks. The study will have a 1:1:1 randomization (CU06-1004 200mg: CU06-1004 300mg: Placebo).

Conditions

DME; Diabetic Macular Edema; Diabetic Macular Edema (DME)

Keywords

Diabetic Macular Edema; DME; endothelial dysfunction blocker

Outcome Measures

Primary Outcomes (1)

• Change of BCVA

  Mean change in best corrected visual acuity (BCVA) from baseline as measured by Early Treatment Diabetic Retinopathy Study (ETDRS) letters score at Week 24 in the study eye.

  24 weeks

Secondary Outcomes (16)

• Mean change in BCVA

  Week 4,8,12 and 18

• Improvement or worsening rate of ETDRS BCVA

  Week 4, 8, 12, 18, 24, and 28

• Change in CST

  Week 4, 8, 12, 18, 24, and 28

• Change in all other subfield thickness

  Week 4, 8, 12, 18, 24, and 28

• Mean change in vessel density (VD) in the superficial capillary plexus (SCP)

  Week 12 and 24

Other Outcomes (4)

• Mean change in BCVA

  Week 4, 8, 12, 18, 24, and 28

• Improvement or worsening rate of ETDRS BCVA

  Week 4, 8, 12, 18, 24, and 28

• Change in CST

  Week 4, 8, 12, 18, 24, and 28

Study Arms (3)

CU06-1004 200mg

EXPERIMENTAL

Oral dose of 200 mg CU06-1004 QD (two 100 mg capsules and one placebo capsule)

Drug: CU06-1004

CU06-1004 300mg

EXPERIMENTAL

Oral dose of 300 mg CU06-1004 QD (three 100 mg capsules)

Drug: CU06-1004

Placebo

EXPERIMENTAL

Oral dose of matching placebo QD (three placebo capsules)

Drug: Placebo Control

Interventions

CU06-1004 DRUG

CU06-1004 is an oral capsule. At room temperature, it appears as a white to off-white powder. The 100 mg soft gelatin capsules contain a solution-based fill.

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

CU06-1004 200mg; CU06-1004 300mg

Placebo Control DRUG

A matching placebo capsule administered orally

Placebo

Eligibility Criteria

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

You may qualify if:

• Have read, understood, and signed the informed consent form.
• Patient is willing and able to comply with all study procedures, and is likely to complete the study, based on the investigator's judgment.
• Male and female patients must be ≥18 years of age at the time of screening visit. Race and ethnicity information will be collected based on National Institutes of Health criteria.
• Has a diagnosis of Type 1 or Type 2 diabetes mellitus.
• Has definite retinal thickening due to DME in the center of the macula of the study eye (either treatment-naïve or previously treated patients).
• The study eye has a BCVA of 25 to 69 (approximate Snellen equivalent of 20/50 to 20/320) at an initial distance of 4 meters, as assessed by the ETDRS letter score at screening.
• Has a study eye with CST of ≥320 µm for men or ≥305 µm for women as determined by Heidelberg Spectralis (or equivalent) SD-OCT (or Zeiss Cirrus OCT: 305 µm for men or 290 µm for women) and confirmed by the CRC at screening.
• Has a DRSS score of ≥43 confirmed by the CRC.
• Has media clarity, pupillary dilation, and patient cooperation sufficient for adequate fundus photographs.
• Is willing to abide by the contraceptive requirements.

You may not qualify if:

• Patients will be excluded from the study if they meet any of the following criteria:
• Has only 1 functional eye, even if the eye met all other study requirements, or has and/or is likely to have amblyopia, amaurosis, or an ocular disorder with BCVA ≤25 ETDRS letter score (approximate Snellen equivalent of \<20/320) in the fellow eye.
• Concurrent and/or history (where indicated) of an ocular condition including one or more of the following in the study eye:
• Active proliferative diabetic retinopathy (PDR) or preretinal fibrosis involving the macula.
• Note: Patients with mild PDR without high-risk features will be allowed in the study.
• Vitreomacular traction or epiretinal membrane that is expected to affect central vision.
• Iris neovascularization, vitreous hemorrhage, or tractional retinal detachment.
• Uncontrolled glaucoma or filtration surgery for glaucoma in the past or likely to be needed in the future
• Intraocular pressure (IOP) \>24 mmHg at screening and randomization. IOP will be assessed by applanation tonometry (Goldmann tonometer, Tono-pen™, or an equivalent device).
• Spherical equivalent of the refractive error of more than 6 diopters myopia or any signs of myopic chorioretinopathy.
• Structural damage to the center of the macula that is likely to preclude improvement in BCVA following the resolution of macular edema, including atrophy of the RPE, subretinal fibrosis or scar, significant macular ischemia, or organized hard exudates.
• Disease other than DME, that could compromise visual acuity, require medical or surgical intervention during the study period, or could confound interpretation of the results (including retinal vascular occlusion, retinal detachment, macular hole, or choroidal neovascularization of any cause) as assessed by the investigator.
• Macular edema is of nondiabetic retinopathy etiology (eg, secondary to vitreomacular interface abnormalities).
• Inability to obtain fundus and OCT images due to, but not limited to, insufficient media clarity or inadequate pupil dilation.
• Aphakia or absence of the posterior capsule. Absence of an intact posterior capsule is allowed if it occurred because of Yttrium-aluminum-garnet (YAG) laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation longer than 2 months before screening.

Sponsors & Collaborators

• Curacle Co., Ltd.: lead

MeSH Terms

Interventions

CU06-1004

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2026
• First Posted: March 10, 2026
• Study Start (Estimated): December 1, 2026
• Primary Completion (Estimated): January 1, 2028
• Study Completion (Estimated): January 30, 2028
• Last Updated: March 10, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share