NCT04884399

Phase I Study to Compare CMAB818 Injection and Lucentis® in Patients With Wet AMD

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.

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Shanghai Biomabs Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Wet Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	CMAB818	vascular endothelial growth factor (VEGF) inhibitor
DRUG	Lucentis®	vascular endothelial growth factor (VEGF) inhibitor

Timeline

• Start date: 2021-06-03
• Primary completion: 2022-12-22
• Completion: 2022-12-22
• First posted: 2021-05-13
• Last updated: 2024-03-28

Locations

4 sites across 1 country: China