Status:
COMPLETED
A Study Assessing the Safety and Efficacy of Multiple Intravitreal KH902 in Patients With CNV Due to AMD
Lead Sponsor:
Chengdu Kanghong Biotech Co., Ltd.
Collaborating Sponsors:
University of Wisconsin, Madison
Air Force Military Medical University, China
Conditions:
Neovascular Age-related Macular Degeneration
Eligibility:
All Genders
45+ years
Phase:
PHASE1
PHASE2
Brief Summary
This study is designed to assess the efficacy and safety of multiple intravitreal injection of KH902 in patients with CNV due to AMD.
Detailed Description
Due to conclusions of KH902 Ia study: Doses of single intravitreal injection of a recombinant human VEGF receptor-Fc fusion protein (KH902) in patients with CNV secondary to neovascular AMD are from ...
Eligibility Criteria
Inclusion
- Signed the Informed Consent Form by patients or legal representative;
- Men and women ≥ 45 years of age;
- Active primary or recurrent lesions with CNV secondary to neovascular AMD;
- Total lesion size ≤ 12 disc areas in either eye;
- BCVA of the study eyes \< 69 letters and the BCVA of fellow eyes ≥ 19 letters;
- Clear ocular media and adequate pupil dilation.
Exclusion
- CNV lesion secondary to ocular conditions other than neovascular AMD
- History of vitreous hemorrhage, retinal tear, rhegmatogenous retinal detachment or macular hole in the study eye;
- Presence of retinal detachment, retinal pigment epithelial tear, or retinal macular traction in the study eye;
- Anaphylactic disease;
- Uncontrolled glaucoma in either eye;
- Current active ocular inflammation or infection in either eye;
- Previous anti-VEGF drug treatment in the study eye within three months preceding screening, and/or, for the fellow eye, within one month preceding screening;
- Previous ophthalmologic operation or laser therapy in the study eye within three months preceding screening;
- Current non-healing wound, ulcer, fractures, etc;
- Uncontrolled systemic conditions;
- Patients of child-bearing potential do not adopted adequate contraception methods;
- Pregnant or nursing women.
Key Trial Info
Start Date :
August 1 2009
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2011
Estimated Enrollment :
36 Patients enrolled
Trial Details
Trial ID
NCT01242254
Start Date
August 1 2009
End Date
February 1 2011
Last Update
March 27 2014
Active Locations (3)
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1
Beijing Tongren Hospital
Beijing, Beijing Municipality, China, 100000
2
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, China, 200000
3
West China Hospital ,Sichuan University
Chengdu, Sichuan, China, 610000