A Phase 1/2 interventional study of Intravitreal injection of KH902 in Neovascular Age-related Macular Degeneration, sponsored by Chengdu Kanghong Biotech Co., Ltd.. Completed at 3 sites in China. Open to participants aged 45 Years and older. Per ClinicalTrials.gov, last updated 2014-03-27.
Sponsored by Chengdu Kanghong Biotech Co., Ltd. · Phase 1/2, Interventional, and Treatment
This study is designed to assess the efficacy and safety of multiple intravitreal injection of KH902 in patients with CNV due to AMD.
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 0.05 mg to 3.0 mg. The trial shows that KH902 is safe and tolerable, and no DLT, ophthalmia reaction, endophthalmitis, or systemic AE relevant to the drug is reported, and the main AEs are transient ocular tension increase and micro-hemorrhage in injection site. KH902 appears to produce rapid clinical effects on VA, supported by improvements in anatomical features, in patients with neovascular AMD.
HOPE Study is an open label, multi-center, randomized, uncontrolled dose-and interval-ranging phase Ib study designed to assess the efficacy and safety of multiple intravitreal injection of KH902 at variable dosing regimen in patients with CNV due to AMD. Two groups of patients will initially receive intravitreal administration of KH902 following the randomization:
Following the initial 12-week fixed-dosing phase of the trial:
Patients in group A and group B will continue to receive monthly intravitreal injections of KH902 with 0.5 mg/50 μl/eye or 2.0 mg/50 μl/eye as same as the doses he/she received during the fixed dosing phase, on an as needed (PRN) dosing schedule, based upon the need for re-treatment in accordance with pre-specified criteria up till week 52.
1,473 studies on the registry are indexed under Macular Degeneration; 206 are open to participants now.
This study's enrollment of 36 is below the median of 51 across 984 interventional studies indexed under Macular Degeneration.
Browse Macular Degeneration studies →Chengdu Kanghong Biotech Co., Ltd. is the lead sponsor of 21 studies on the registry; 2 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Patients will receive an intravitreal injection of KH902 0.5mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52
Biological: Intravitreal injection of KH902
Patients will receive an intravitreal injection of KH902 2.0mg/eye/time monthly, after 3-time treatment patients will go on an as needed (PRN) dosing phase till week 52
Biological: Intravitreal injection of KH902
0.5 mg 2.0 mg once per 4 weeks during fixed dosing phase once as needed during extended treatment phase
The incidence rate of adverse event
To evaluate the safety of multiple intravitreal injection of KH902 of each group.
Time frame: at 52 week
Change from Baseline in BCVA
To evaluate the efficacy of multiple intravitreal injection of KH902 of each group in the mean change from baseline
Time frame: Specified timepoints during the screening phase and 52-week treatment period
This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.
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Chengdu Kanghong Biotech Co., Ltd.