Study of CU06-1004 in Patients With Daibetic Macular Edema (NCT07459829) | Clinical Trial Compass
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 range
18 Years
Sex
ALL
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
. 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.