Clinical trial NCT01157715: A Randomized, Double-masked, Multicenter, Controlled Study of Intravitreal KH902 in Patients With Neovascular AMD
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Neovascular Age-related Macular Degeneration
Keywords: KH902
age-related macular degeneration (AMD)
choroidal neovascularization (CNV)
intravitreal injection
best corrected visual acuity (BCVA)
central retinal thickness
Lead sponsor: Chengdu Kanghong Biotech Co., Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Beijing DMS Pharma Ltd.
name: The Digital Angiography Reading Center (DARC)
First posted: 2010-07-07
Enrollment: 122
Sex: ALL
Minimum age (years): 50
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in BCVA
timeFrame: at 3-month
measure: The incidence rate of adverse event
timeFrame: at 3-month
Secondary outcomes:
measure: Change from baseline in central retinal thickness
timeFrame: at 3-month and 12-month
Other outcomes:
Locations:
city: Wenzhou
country: China
facility: Optometry and Ophthalmology Hospital of Wenzhou Medical College
state: Fujian
city: Guangzhou
country: China
facility: Zhongshan Ophthalmic Center, Sun-Yat University
state: Guangdong
city: Changsha
country: China
facility: Second Affiliated Hospital of Xiangya Medical College
state: Hunan
city: Xian
country: China
facility: Xijing Hosiptal of the Fourth Military Medical University
state: Shanxi
city: Chengdu
country: China
facility: Sichuan University West China Hospitcal
state: Sichuan
city: Peking
country: China
facility: Peking University People's Hospital
city: Peking
country: China
facility: PekingTongren Hospital
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
city: Shanghai
country: China
facility: Shanghai First People's Hospital
Study officials:
affiliation: Peking University People's Hospital
name: Xiaoxin Li, MD, Prof.
role: PRINCIPAL_INVESTIGATOR
References: