A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
Summary
Part A of the study is conducted to select the THR-149 dose level. Part B of the study is conducted to assess the efficacy and safety of the selected dose level compared to aflibercept, up to Month 3. As from Month 3, in about half of the subjects, the effect of a single flip-over injection (aflibercept or THR-149) will be evaluated when administered 1 month after the 3 monthly injections of THR-149 or aflibercept. In the other subjects, the durability of 3 monthly injections of THR 149 or aflibercept will be evaluated.
Timeline
- Start
- 2020-07-31
- Primary completion
- 2023-09-28
- Completion
- 2023-11-22
Outcome
Missed primary endpoint
release “KALAHARI Phase 2, Part B clinical trial for diabetic macular edema (DME) (KALAHARI trial) did not demonstrate that its novel PKal Inhibitor, THR-149, improved vision” oxurion.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Aflibercept | Protein / enzyme biologic | 2 mg | Other |
| Subject | THR-149 | Unknown | 0.13 mg | Other |