Not Yet RecruitingPhase 2

Study of CU06-1004 in Patients With Daibetic Macular Edema

156 participantsStarted 2026-12-01

Plain-language 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).

Who can participate

Age range18 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion criteria

✓. 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.

Exclusion 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.
✕. 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.

What they're measuring

Change of BCVA

Timeframe: 24 weeks

Trial details

NCT IDNCT07459829

SponsorCuracle Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2028-01-01

View on ClinicalTrials.gov More DME trials