Efficacy and Safety Trial of Conbercept Intravitreal Injection for Neovascular Age-related Macular Degeneration (PANDA-1)

  • STATUS
    Not Recruiting
  • End date
    Jan 29, 2022
  • participants needed
    1140
  • sponsor
    Chengdu Kanghong Biotech Co., Ltd.
Updated on 30 June 2021
photodynamic therapy
vegf
growth factor
vascular endothelial growth factor
neovascularization
aflibercept
polypoidal choroidal vasculopathy
eylea
spectral domain optical coherence tomography
age-related macular degeneration

Summary

The purpose of this clinical study is to evaluate the efficacy and safety of two different levels of conbercept intravitreal (IVT) injection as compared to the approved vascular endothelial growth factor (VEGF) antagonist active control, aflibercept intravitreal injection (2.0 mg/eye, Eylea), in subjects with neovascular AMD.

Description

A multicenter, multinational, double-masked, parallel-group, dose-ranging, active-controlled, randomized trial, which will randomize approximately 1140 subjects in a ratio of 1:1:1 to receive IVT injections of 0.5 mg conbercept, 1.0 mg conbercept, or 2.0 mg aflibercept. The trial includes a screening period of less than or equal to 14 days, followed by a treatment period of 92 weeks (last assessment at 96 weeks) with primary efficacy analysis at 36 weeks.

Details
Condition Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration, Neovascular Age-related Macular Degeneration
Treatment 0.5 mg Conbercept Intravitreal Injection, 1.0 mg Conbercept Intravitreal Injection, 2.0 mg Aflibercept Intravitreal Injection
Clinical Study IdentifierNCT03577899
SponsorChengdu Kanghong Biotech Co., Ltd.
Last Modified on30 June 2021

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