5324592
Last Update Posted: 2022-04-12
Recruiting has ended
All Genders accepted | 18 Years-80 Years |
24 Estimated Participants | No Expanded Access |
Interventional Study | Does not accept healthy volunteers |
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).
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.
Eligibility
Relevant conditions:
Diabetic Macular Edema
If you aren't sure if you meet the criteria above speak to your healthcare professional. Criteria may be updated but not reflected here, do not hesitate to contact the trial if you think are close to fitting criteria.
locations
Data sourced from ClinicalTrials.gov