Trials / Completed
CompletedNCT05324592
Safety and Efficacy of 9MW0813 in Subjects With Diabetic Macular Edema
A Multicenter, Randomized, Double-blind, Parallel-controlled Phase I Trial Comparing the Safety, Pharmacokinetics and Efficacy of 9MW0813 and Aflibercept (EYLEA®) After a Single Dose in Patients With Diabetic Macular Edema (DME)
- Status
- Completed
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 24 (actual)
- Sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
A multicenter, randomized, double-blind, parallel-controlled phase I trial comparing the safety, pharmacokinetics and efficacy of 9MW0813 and aflibercept (EYLEA®) after a single dose in patients with diabetic macular edema (DME).
Detailed description
This is a multi-center, randomized, double-blind, parallel controlled Phase I clinical trial. The primary objective is to compare the safety of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients. The secondary objectives are to comparing the pharmacokinetic profile, immunogenicity and efficacy of a single intravitreal injection (IVT) of 9MW0813 injection and aflibercept intraocular injection solution (EYLEA®) in DME patients.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 9MW0813 | The active ingredient of 9MW0813 injection is recombinant human vascular endothelial growth factor receptor-antibody fusion protein. One dose(2mg) of the drug will be injected intravitreously. |
| DRUG | Aflibercept | Aflibercept (trade name: Eylea®/EYLEA®) is an anti-VEGF drug developed by Regeneron/Bayer. It is a fusion protein of human VEGFR1 and VEGFR2 extracellular domains and human immunoglobulin Fc segment genes. One dose(2mg) of the drug will be injected intravitreously. |
Timeline
- Start date
- 2021-02-26
- Primary completion
- 2021-09-24
- Completion
- 2022-01-25
- First posted
- 2022-04-12
- Last updated
- 2022-04-12
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT05324592. Inclusion in this directory is not an endorsement.