Status:
COMPLETED
A Randomized, Double-masked, Multicenter,Sham-controlled, Safety and Efficacy Study of KH902 in Patients With Wet AMD
Lead Sponsor:
Chengdu Kanghong Biotech Co., Ltd.
Collaborating Sponsors:
University of Wisconsin, Madison
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE3
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 c...
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 ...
Eligibility Criteria
Inclusion
- 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
- 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;
Key Trial Info
Start Date :
August 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2013
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT01436864
Start Date
August 1 2011
End Date
November 1 2013
Last Update
April 18 2023
Active Locations (11)
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1
First Affiliated Hospital of Fujian Medical College
Fuzhou, Fujian, China, 350005
2
Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong
Shantou, Guangdong, China, 515041
3
People's Hospital of Wuhan University
Wuhan, Hubei, China, 430060
4
Wuhan General Hospital of Guangzhou Military Command
Wuhan, Hubei, China, 430070