Status:
COMPLETED
A Randomized, Double-masked, Multicenter, Controlled Study of Intravitreal KH902 in Patients With Neovascular AMD
Lead Sponsor:
Chengdu Kanghong Biotech Co., Ltd.
Collaborating Sponsors:
Beijing DMS Pharma Ltd.
The Digital Angiography Reading Center (DARC)
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
50+ years
Phase:
PHASE2
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 ...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
May 1 2010
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
122 Patients enrolled
Trial Details
Trial ID
NCT01157715
Start Date
May 1 2010
End Date
July 1 2012
Last Update
November 6 2014
Active Locations (9)
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1
Optometry and Ophthalmology Hospital of Wenzhou Medical College
Wenzhou, Fujian, China, 325027
2
Zhongshan Ophthalmic Center, Sun-Yat University
Guangzhou, Guangdong, China, 510060
3
Second Affiliated Hospital of Xiangya Medical College
Changsha, Hunan, China, 410011
4
Xijing Hosiptal of the Fourth Military Medical University
Xian, Shanxi, China, 710032