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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
CU06-1004
DrugCU06-1004 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.
Placebo Control
DrugA matching placebo capsule administered orally
Treatment groups
156 Participants
are divided into 3 treatment groupsGroup A: CU06-1004 200mgExperimental treatment 1 intervention
Group B: CU06-1004 300mgExperimental treatment 1 intervention
Group C: PlaceboExperimental treatment 1 intervention
Trial outcomes
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.
Time frame
24 weeksSecondary outcomes
1
Mean change in BCVA
Mean change in BCVA from baseline as measured by ETDRS letters score at Weeks 4, 8, 12, and 18.
Time frame
Week 4,8,12 and 182
Improvement or worsening rate of ETDRS BCVA
Improvement or worsening rate of ETDRS BCVA from baseline: percentage of patients who gained/lost ≥5/10/15 letter score increase of vision in the ETDRS letter score from baseline at each visit.
Time frame
Week 4, 8, 12, 18, 24, and 283
Change in CST
Change in central subfield thickness (CST) in the study eye assessed at each visit by spectral domain optical coherence tomography (SD-OCT) measured by the central reading center (CRC) from baseline
Time frame
Week 4, 8, 12, 18, 24, and 284
Change in all other subfield thickness
Change in all other subfield thickness (nasal, temporal, superior, and inferior) in the study eye from baseline, assessed at each visit by SD-OCT using the ETDRS macular grid (the area between 1 mm to 3 mm and 3 mm to 6 mm by quadrant).
Time frame
Week 4, 8, 12, 18, 24, and 28Other outcomes
1
Mean change in BCVA
Mean change in BCVA from baseline as measured by ETDRS letters score at each postbaseline visit. - fellow eye
Time frame
Week 4, 8, 12, 18, 24, and 282
Improvement or worsening rate of ETDRS BCVA
Improvement or worsening rate of ETDRS BCVA from baseline: percentage of patients who gained/lost ≥5/10/15 letter score increase of vision in the ETDRS letter score from baseline - fellow eye
Time frame
Week 4, 8, 12, 18, 24, and 283
Change in CST
Change in CST assessed at each visit by SD-OCT measured by CRC from baseline.
Time frame
Week 4, 8, 12, 18, 24, and 284
Change in ETDRS DRSS
Change in ETDRS DRSS at Weeks 12 and 24 measured by CRC compared to baseline. - fellow eye
Time frame
Week 12 and 24Locations
Sponsors and contacts
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Source ClinicalTrials.gov
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