A study to investigate danegaptide in participants with diabetic macular edema
Research type
Research Study
Full title
A Phase 1b open-label, dose-escalating study evaluating the safety, tolerability, pharmacokinetics, and early signs of biological activity of danegaptide following oral administration in participation with diabetic macular edema
IRAS ID
1007664
Contact name
Ulrik Mouritzen
Contact email
Sponsor organisation
Breye Therapeutics ApS
ISRCTN Number
ISRCTN13284995
Research summary
Diabetic retinopathy is a disease of the small blood vessels at the back of the eye. It is a serious complication of both Type 1 and Type 2 diabetes mellitus and a leading cause of blindness in working age adults. The main objective of this study is to investigate the safety of a drug ‘danegaptide’ and the extent to which any side effects can be tolerated by people with diabetes. The researchers will investigate how the human body absorbs and breaks down the drug and will look for early signs of how the drug affects the diabetic retinopathy. This is a dose escalating study including 4 groups of 6 subjects: \n•\tCohort 1: 75 mg once daily \n•\tCohort 2: 75 mg twice daily\n•\tCohort 3: 150 mg once daily \n•\tCohort 4: 150 mg twice daily\nBoth the participants and the researchers will know what does of the drug they are receiving. After completion of each study group, a study Safety Review Committee will review all available data collected on safety, tolerability, and how the body acts on the drug to ensure it is safe to proceed with the next planned dose increase. Six participants will be enrolled per treatment group, and the study protocol allows for an expansion of the group with additional 6 participants in case a safety observation requires further assessment and generation of additional data. Hence, up to a total of 36 participants will receive danegaptide during the study.\nParticipants in each treatment cohort will receive danegaptide by mouth starting on Day 1 and continuing to Day 28. The total duration of study participation for each participant will be up to 70 days, including a period of up to 28 days when eligibility for the study will be assessed, a period of 28 days when the drug is taken, and a follow-up period of 14 days. There will be at total of 8 visits.
REC name
North West - Greater Manchester South Research Ethics Committee
REC reference
23/NW/0152
Date of REC Opinion
27 Sep 2023
REC opinion
Further Information Favourable Opinion