Trials / Active Not Recruiting
Active Not RecruitingNCT06116916
Study to Assess the Efficacy & Safety of KHK4951 in Patients With Diabetic Macular Edema
A Phase 2, Multicenter, Randomized, Double-Masked, Parallel-Group Study to Assess the Efficacy and Safety of KHK4951, a Vascular Endothelial Growth Factor Receptor Inhibitor, in Patients With Diabetic Macular Edema
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 150 (estimated)
- Sponsor
- Kyowa Kirin Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate efficacy and safety of KHK4951 eye drops in patients with DME.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | KHK4951 | KHK4951 eye drop for 36 weeks until end of the trial |
| DRUG | Aflibercept Injection | Intravitreal injection (IVT) of aflibercept will be given as specified in the protocol |
Timeline
- Start date
- 2024-01-09
- Primary completion
- 2026-08-31
- Completion
- 2026-09-30
- First posted
- 2023-11-03
- Last updated
- 2025-10-30
Locations
87 sites across 4 countries: United States, Australia, Japan, South Korea
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06116916. Inclusion in this directory is not an endorsement.