NCT01324869

Safety and Efficacy by Multiple Injection of KH902 in Patients With Diabetic Macular Edema (DME)

An Open-label, Randomized, Uncontrolled, Preliminary Clinical Study to Evaluate the Safety and Efficacy of KH902 Following Multiple Intravitreal Injection in Patients With Diabetic Macular Edema

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Chengdu Kanghong Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

This study is designed to access the safety and efficacy of multiple injections of KH902 in patients with Diabetic Macular Edema (DME).

Detailed description

With improvement of our living standard, patients who suffered from Diabetes become more and more. As the investigators know, Diabetes can induce many ocular diseases leading to vision loss. And according to observations, DME is diagnosed as one main cause of vision loss in the patients with Diabetes. As the results of many studies conducted previously, anti-VEGF drugs and anti-VEGF treatments show its effect and safety not only in treating AMD, but also in patients with DME. The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The previous clinical trials of KH902 show that KH902 is effective and safe in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF. Due to these positive results, the investigators prepare to conduct a clinical trial to assess the safety and efficacy with intravitreal injection of KH902 in patients with DME.

Conditions

• Diabetic Macular Edema

Interventions

Type	Name	Description
BIOLOGICAL	KH902	Intravitreal injection of 0.5mg/eye/time KH902

Timeline

• Start date: 2010-04-01
• Primary completion: 2012-02-01
• Completion: 2012-10-01
• First posted: 2011-03-29
• Last updated: 2013-03-01

Locations

1 site across 1 country: China