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Clinical Trial Summary

This is a randomized, double-blind, two-group parallel, positive-controlled clinical Phase I trial comparing the safety, pharmacokinetics, pharmacodynamics and efficacy of CMAB818 and Lucentis® in patients with wet age-related macular degeneration.


Clinical Trial Description

This is a phase I, randomized, double-blind, two-group parallel, positive-controlled clinical trial at four sites. Subjects will be sequentially enrolled according to the protocol in one of two cohorts and receive a single 0.5mg of CMAB818 or Lucentis® through intravitreal injection. The primary objective is to assess the initial clinical safety of intravitreal injection of CMAB818 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD). The secondary objective are to assess immnogenicity, pharmacokinetic, pharmacodynamics and the initial clinical efficacy of intravitreal injection of CMAB818 or Lucentis® in patients with wet age-related macular degeneration (wet-AMD). ;


Study Design


Related Conditions & MeSH terms


NCT number NCT04884399
Study type Interventional
Source Shanghai Biomabs Pharmaceutical Co., Ltd.
Contact
Status Completed
Phase Phase 1
Start date June 3, 2021
Completion date December 22, 2022

See also
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