NCT04486963

A Phase Ⅱ Clinical Study of Sanhuangjingshimingwan in Wet( Neovascular)Age-related Macular Degeneration(wAMD) Subjects

A Randomized, Double-blind, Placebo-controlled, Ranibizumab Injected, Multicenter Phase II Clinical Study on the Efficacy and Safety of Sanhuangjingshimingwan in the Wet AMD(Qi and Yin Deficiency, Phlegm-blood Stasis Syndrome )Subjects

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 78 (actual)
• Sponsor: Tasly Pharmaceutical Group Co., Ltd · Industry
• Sex: All
• Age: 50 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan in Wet AMD.

Detailed description

The study is to evaluate the efficacy and safety of Sanhuangjingshimingwan,give two times a day versus placebo in wAMD .The clinical phase of the study comprises a 6-months double-blind treatment period, resulting in 6.5-months overall duration of the study for each patient.

Conditions

• Age-related Macular Degeneration

Interventions

Type	Name	Description
DRUG	Sanhuangjingshimingwan	Sanhuangjingshimingwan,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.
DRUG	Sanhuangjingshimingwan Placebo	Sanhuangjingshimingwan Placebo,12g,Bid,6 months.Anti VEGF injection will be injected monthly if needed.

Timeline

• Start date: 2020-07-24
• Primary completion: 2022-11-01
• Completion: 2022-11-15
• First posted: 2020-07-27
• Last updated: 2022-11-25

Locations

6 sites across 1 country: China