A Randomized, Double-masked, Multicenter, Controlled Study of Intravitreal KH902 in Patients With Neovascular AMD

Neovascular Age-related Macular Degeneration Clinical Trial

— AURORA  

Official title:

A Randomized, Double-masked, Multicenter, Controlled Dose- and Interval-ranging Clinical Study of Intravitreal Injection of KH902 in Patients With Neovascular Age-related Macular Degeneration (the AURORA Study)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01157715
• Other study ID #: KHSWKH902001
• Status: Completed
• Phase: Phase 2
• First received: July 6, 2010
• Last updated: November 5, 2014
• Start date: May 2010
• Est. completion date: July 2012

Study information

• Verified date: November 2014
• Source: Chengdu Kanghong Biotech Co.,Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: China: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 122
• Est. completion date: July 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 50 Years and older

Eligibility

Inclusion criteria:

• Signed the ICF; Age = 50 years of either gender;

• Active primary or recurrent lesions with subfoveal or juxtafoveal CNV secondary to neovascular AMD in the study eye;

• Lesion size = 12 disc areas in either eye;

• BCVA of the study eyes between 73 and 24 letters, inclusively, and the BCVA of fellow eyes = 19 letters;

• Clear ocular media and adequate pupil dilation.

• If both eyes were eligible, only one was selected.

Exclusion criteria:

• History of vitreous hemorrhage, retinal detachment or macular hole, presence of retinal pigment epithelial tear, retinal macular traction or macular epiretinal membrane in the study eye;

• Subfoveal scar or atrophy in the study eye;

• Subretinal hemorrhage in the study eye;

• Uncontrolled glaucoma in either eye;

• Active inflammation or infection in either eye;

• Previous drug treatment, either anti-VEGF drugs or steroid derivatives, and/or, previous ophthalmologic operation or laser therapy in the study eye;

• History of surgery within one month preceding enrollment;

• Any uncontrolled clinical disorders;

• Patients of child-bearing potential do not adopted adequate contraception methods;

• Pregnant or nursing women;

• Patients need to exclude in the opinion of investigator.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Macular Degeneration
• Neovascular Age-related Macular Degeneration
• Wet Macular Degeneration

Intervention

Biological:
• intravitreal injection of KH902

Locations

Country	Name	City	State
China	Second Affiliated Hospital of Xiangya Medical College	Changsha	Hunan
China	Sichuan University West China Hospitcal	Chengdu	Sichuan
China	Zhongshan Ophthalmic Center, Sun-Yat University	Guangzhou	Guangdong
China	Peking University People's Hospital	Peking
China	PekingTongren Hospital	Peking
China	Eye & ENT Hospital of Fudan University	Shanghai
China	Shanghai First People's Hospital	Shanghai
China	Optometry and Ophthalmology Hospital of Wenzhou Medical College	Wenzhou	Fujian
China	Xijing Hosiptal of the Fourth Military Medical University	Xian	Shanxi

Sponsors (3)

Lead Sponsor	Collaborator
Chengdu Kanghong Biotech Co.,Ltd.	Beijing DMS Pharma Ltd., The Digital Angiography Reading Center (DARC)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change from baseline in BCVA		at 3-month	No
Primary	The incidence rate of adverse event		at 3-month	Yes
Secondary	Change from baseline in central retinal thickness		at 3-month and 12-month	No