A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD

Neovascular Age-related Macular Degeneration Clinical Trial

— PHOENIX  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01436864
• Other study ID #: KHSWKH902005
• Status: Completed
• Phase: Phase 3
• Start date: August 2011
• Est. completion date: November 2013

Study information

• Verified date: April 2023
• Source: Chengdu Kanghong Biotech Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 125
• Est. completion date: November 2013
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: 50 Years and older

Eligibility

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;

Related Conditions & MeSH terms

• Choroidal Neovascularization
• Macular Degeneration
• Neovascular Age-related Macular Degeneration

Intervention

Biological:
• Recombinant Human VEGF Receptor-Fc Fusion Protein
Intravitreal injection of KH902 once per month

Locations

Country	Name	City	State
China	Daping Hospital of the Third Military Medical University	Chongqing
China	First Affiliated Hospital of Fujian Medical College	Fuzhou	Fujian
China	Ophthalmologic Hospital of Qingdao	Qingdao	Shandong
China	Eye & ENT Hospital of Fudan University	Shanghai	Shanghai
China	Shanghai First People's Hospital	Shanghai
China	Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong	Shantou	Guangdong
China	The First Hospital of China Medical University	Shenyang	Liaoning
China	Affiliated Hospital of Wenzhou Medical College	Wenzhou	Zhejiang
China	People's Hospital of Wuhan University	Wuhan	Hubei
China	Wuhan General Hospital of Guangzhou Military Command	Wuhan	Hubei
China	Wuxi Second People's Hospital	Wuxi	Jiangsu

Sponsors (2)

Lead Sponsor	Collaborator
Chengdu Kanghong Biotech Co., Ltd.	University of Wisconsin, Madison

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Mean change from baseline in BCVA	To evaluate the mean change from baseline in best-corrected visual acuity (BCVA) in KH902 treatment group and sham treatment group at month 3 and compare the difference between the values	at month 3
Secondary	The incidence rate of adverse event	To evaluate the difference in safety assessment between Conbercept (KH902) group and Sham group at month 3.	at month 3
Secondary	Mean change of retinal thickness from baseline	To evaluate the mean change of retinal thickness from baseline in KH902 treatment group or sham treatment group at month 3.	at month 3