A Randomized, Double-masked, Multicenter, Controlled Study of Intravitreal KH902 in Patients With Neovascular AMD
- Conditions
- Neovascular Age-related Macular Degeneration
- Interventions
- Biological: intravitreal injection of KH902
- Registration Number
- NCT01157715
- Lead Sponsor
- Chengdu Kanghong Biotech Co., Ltd.
- Brief Summary
This study is designed to access the safety and efficacy of multiple injections of KH902 at variable dosing regimens in patients with CNV due to neovascular AMD.
- Detailed Description
AMD is the leading cause of severe vision loss in people over the age of 65 in the United States and other western countries. A quantity of documents indicate that neovascularization promoted by VEGF is main cause of visual acuity decline. Patients are starving for a new drug which can notably improve VA with less administration frequency and lower treatment cost.
The new drug Recombinant Human VEGF Receptor-Fc Fusion Protein (KH902) is a gene fusion protein. The pre-clinical researches and phase I study show that KH902 is effective and safe in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF.
This study is designed to confirm the efficacy and safety of multiple injections of KH902 at variable dosing regimen in patients with CNV due to neovascular AMD. Based on the characteristics of KH902 and results from KH902 Phase I study as well as reference to clinical trials of similar drugs, it is determined that KH902 is administrated at 0.5mg/eye/time and 2.0mg/eye/time.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 122
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 2.0 mg cohort intravitreal injection of KH902 patients will receive monthly intravitreal injections of 2.0 mg KH902 for 3 times in the study eye;following the initial 3-month fixed-dosing phase of the trial, patients will be randomized in a 1:1 ratio into one of two groups as follows: i. q1m group: patients will continue to receive monthly intravitreal injections of KH902 at the same dose received during the fixed dosing phase; ii. prn group: patients will continue to receive injection of KH902 at the same dose received during the fixed dosing phase, on an as needed (PRN) dosing schedule based upon the physician assessment of the need for re-treatment in accordance with pre-specified criteria . 0.5 mg cohort intravitreal injection of KH902 patients will receive monthly intravitreal injections of 0.5 mg KH902 for 3 times in the study eye;following the initial 3-month fixed-dosing phase of the trial, patients will be randomized in a 1:1 ratio into one of two groups as follows: i. q1m group: patients will continue to receive monthly intravitreal injections of KH902 at the same dose received during the fixed dosing phase; ii. prn group: patients will continue to receive injection of KH902 at the same dose received during the fixed dosing phase, on an as needed (PRN) dosing schedule based upon the physician assessment of the need for re-treatment in accordance with pre-specified criteria .
- Primary Outcome Measures
Name Time Method Change from baseline in BCVA at 3-month The incidence rate of adverse event at 3-month
- Secondary Outcome Measures
Name Time Method Change from baseline in central retinal thickness at 3-month and 12-month
Trial Locations
- Locations (9)
PekingTongren Hospital
🇨🇳Peking, China
Eye & ENT Hospital of Fudan University
🇨🇳Shanghai, China
Second Affiliated Hospital of Xiangya Medical College
🇨🇳Changsha, Hunan, China
Optometry and Ophthalmology Hospital of Wenzhou Medical College
🇨🇳Wenzhou, Fujian, China
Zhongshan Ophthalmic Center, Sun-Yat University
🇨🇳Guangzhou, Guangdong, China
Xijing Hosiptal of the Fourth Military Medical University
🇨🇳Xian, Shanxi, China
Shanghai First People's Hospital
🇨🇳Shanghai, China
Sichuan University West China Hospitcal
🇨🇳Chengdu, Sichuan, China
Peking University People's Hospital
🇨🇳Peking, China