Study of CU06-1004 in Patients With Daibetic Macular Edema
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorCuracle Co., Ltd.
About this trial
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).
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
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.
Trial design
Treatments tested in this trial
- CU06-1004
- Placebo Control
Treatment groups
156 Participants
are divided into 3 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov