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

NCT04884399 · Status: COMPLETED · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 24

Last updated 2024-03-28

No results posted yet for this study

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.

Conditions

Interventions

DRUG

CMAB818

vascular endothelial growth factor (VEGF) inhibitor

DRUG

Lucentis®

vascular endothelial growth factor (VEGF) inhibitor

Sponsors & Collaborators

  • Shanghai Biomabs Pharmaceutical Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Wenbin Wei, PhD · Beijing Tongren Hospital

  • Xiuli Zhao, PhD · Beijing Tongren Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
50 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-06-03
Primary Completion
2022-12-22
Completion
2022-12-22

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04884399 on ClinicalTrials.gov