Clinical trial NCT01436864: A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD
Official title: A Phase 3 Clinical Trial of Intravitreal Injections of Human Recombinant Vascular Endothelial Growth Factor Receptor-Fc Fusion Protein in Patients With Choroidal Neovascularization Secondary to Age-related Macular Degeneration
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Neovascular Age-related Macular Degeneration
Keywords: Recombinant Human VEGF Receptor-Fc Fusion Protein (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: University of Wisconsin, Madison
First posted: 2011-09-20
Enrollment: 125
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 prove and confirm the efficacy and safety of multiple injections of human recombinant vascular endothelial growth factor receptor-Fc fusion protein (KH902) in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.

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 the 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 II study showed that KH902 is well-tolerated,and safe, it is effective in inhibiting the growth, migration, pullulation of vascular endothelial cells and neovascularization induced by VEGF.

This study is designed to prove and confirm the efficacy and safety of multiple injections of KH902 in patients with choroidal neovascularization due to neovascular age-related macular degeneration by comparing intravitreal injections of KH902 with sham-injections.

Eligibility criteria: Inclusion Criteria:

* Signed the Informed Consent Form;
* Age ≥ 50 years of either gender;
* Total lesion size ≤ 30 mm2 of the study eye;
* BCVA score of the study eye between 73 and 19 letters;
* Clear ocular media and adequate pupil dilation to permit good quality fundus photographic imaging.
* BCVA score of the fellow eye ≥ 19 letters.

Exclusion Criteria:

* Current or previous non-exudative AMD diseases which affect the inspection and measurement of macular or the central visual acuity;
* Subretinal hemorrhage area≥ 50% of total lesion size;
* Scar or fibrosis area in study eyes ≥ 50% of total lesion size; or central foveal scar、fibrosis or atrophy of macular in the study eye;
* Presence of retinal pigment epithelial tear, retinal macular tractional, macular epiretinal membrane, and diagnosed with polypoidal choroidal vasculopathy in the study eye;
* Previous anti-VEGF drug treatment in the study eye within six months preceding screening; or anti-VEGF treatment in the fellow eye within three months before screening;
* Previous intraocular or periocular operations, excluding operations on eyelid without hampering the intravitreal injection in the study eye;
* Previous ophthalmologic operations in the study eye;
* Current active inflammation or infection in either eye;
* Uncontrolled previous or current glaucoma in either eye, or previous glaucoma filtering operation in the study eye;
* Current systemic administrations which may lead to toxicity in the crystalline lens;
* History of allergy or current allergic response;
* History of surgery within one month preceding enrollment;
* Infectious diseases need systemic administration;
* Systemic autoimmune diseases;
* Any uncontrolled clinical disorders;
* Patients of child-bearing potential do not adopted adequate contraception methods;
* Pregnant or nursing women;
* Patients should be excluded in the opinion of investigators;

Primary outcomes:
measure: Mean change from baseline in BCVA
timeFrame: at month 3
Secondary outcomes:
measure: The incidence rate of adverse event
timeFrame: at month 3
measure: Mean change of retinal thickness from baseline
timeFrame: at month 3
Other outcomes:
Locations:
city: Fuzhou
country: China
facility: First Affiliated Hospital of Fujian Medical College
state: Fujian
city: Shantou
country: China
facility: Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
state: Guangdong
city: Wuhan
country: China
facility: People's Hospital of Wuhan University
state: Hubei
city: Wuhan
country: China
facility: Wuhan General Hospital of Guangzhou Military Command
state: Hubei
city: Wuxi
country: China
facility: Wuxi Second People's Hospital
state: Jiangsu
city: Shenyang
country: China
facility: The First Hospital of China Medical University
state: Liaoning
city: Qingdao
country: China
facility: Ophthalmologic Hospital of Qingdao
state: Shandong
city: Shanghai
country: China
facility: Eye & ENT Hospital of Fudan University
state: Shanghai
city: Wenzhou
country: China
facility: Affiliated Hospital of Wenzhou Medical College
state: Zhejiang
city: Chongqing
country: China
facility: Daping Hospital of the Third Military Medical University
city: Shanghai
country: China
facility: Shanghai First People's Hospital
Study officials:
affiliation: Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine
name: Xun Xu
role: PRINCIPAL_INVESTIGATOR
References: