This phase 2a trial is a randomized, open-label, parallel-group study in approximately 60 patients with DME to evaluate the efficacy and safety of CU06-1004 orally administered once daily for 12 weeks. The study will have a 1:1:1 randomization (CU06-1004 100mg: CU06-1004 200mg: CU06-1004 300mg).
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
67
CU06-1004 per capsule for oral administration. CU06-1004 is a white off powder at room temperature. The CU06-1004 100 mg soft gelatin capsules consist of a solution-based fill.
Rand Eye Institute
Deerfield Beach, Florida, United States
Elman Retina Group
Baltimore, Maryland, United States
Cumberland Valley Retina Consultants
Hagerstown, Maryland, United States
The change of central subfield thickness (CST)
Change in CST in the study eye assessed by SD-OCT at Week 12 compared to baseline
Time frame: Baseline and 12 weeks
To determine the optimal doses
The 1:1:1 randomization is fitting for the study objective to determine the optimal doses for a phase 2b study.
Time frame: 12 weeks
The change of central subfield thickness (CST)
Change in CST in the study eye assessed by SD-OCT Weeks 4 and 8 compared to baseline
Time frame: Baseline, 4 weeks and 8 weeks
The change of all other subfield thickness
Change in all other subfield thickness (Nasal, temporal, superior and inferior) in the study eye assessed by SD-OCT at Weeks 4, 8, and 12 compared to baseline
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
The change of early treatment diabetic retinopathy study (ETDRS) best-corrected visual acuity (BCVA) letter score
Change in ETDRS BCVA letter score in the study eye at Weeks 4, 8, and 12 compared to baseline
Time frame: Baseline, 4 weeks, 8 weeks and 12 weeks
Change in diabetic retinopathy severity scale (DRSS)
Change in DRSS in the study eye at Weeks 12 compared to baseline
Time frame: Baseline and 12 weeks
The change of blood biomarkers
Change in blood biomarker (TNF-alpha, IL-1 beta, IL-6) at Week 12 compared to baseline
Time frame: Baseline and 12 weeks
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Ophthalmic Consultants of Boston
Boston, Massachusetts, United States
New England Retina Consultants
Springfield, Massachusetts, United States
Mid Atlantic Retina
Bethlehem, Pennsylvania, United States
Austin Research Center for Retina
Austin, Texas, United States
Retina consultant of Texas
Bellaire, Texas, United States
Valley Retina Institute
McAllen, Texas, United States
Wagner Macula and Retina Center
Norfolk, Virginia, United States
...and 1 more locations
Number and severity of treatment emergent adverse events (TEAEs)
Number and severity of TEAEs up to Week 12 compared to baseline
Time frame: Baseline and 12 weeks