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| Name | Class |
|---|---|
| University of Wisconsin, Madison | OTHER |
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 0.5 mg KH902 | Experimental | Patients will receive intravitreal injection of KH902 0.5mg/eye once per month for three times in the study eye, and then patients will receive 2 sham injections monthly, respectively, at the end of month 3 (visit 5), and following these injections you will receive intravitreal injection of KH902 once every three months, till month 12 (respectively at month 5, month 8 and month 11) |
|
| Sham-injection | Sham Comparator | Patients will receive sham injection once per month for three times, and then you will receive intravitreal injection of KH902 0.5mg/eye once per month for three times in the study eye, after three months' treatment they will receive intravitreal injection of KH902 once every three months, till month 12 (respectively at month 8 and month 11. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Recombinant Human VEGF Receptor-Fc Fusion Protein | Biological | Intravitreal injection of KH902 once per month |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Mean change of retinal thickness from baseline |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xun Xu | Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| First Affiliated Hospital of Fujian Medical College | Fuzhou | Fujian | 350005 | China | ||
| Joint Shantou International Eye Center of Shantou University and The Chinese University of Hong Kong |
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To evaluate the mean change of retinal thickness from baseline in KH902 treatment group or sham treatment group at month 3.
| at month 3 |
| Shantou |
| Guangdong |
| 515041 |
| China |
| People's Hospital of Wuhan University | Wuhan | Hubei | 430060 | China |
| Wuhan General Hospital of Guangzhou Military Command | Wuhan | Hubei | 430070 | China |
| Wuxi Second People's Hospital | Wuxi | Jiangsu | 214002 | China |
| The First Hospital of China Medical University | Shenyang | Liaoning | 110001 | China |
| Ophthalmologic Hospital of Qingdao | Qingdao | Shandong | 266071 | China |
| Eye & ENT Hospital of Fudan University | Shanghai | Shanghai Municipality | 200031 | China |
| Affiliated Hospital of Wenzhou Medical College | Wenzhou | Zhejiang | 325027 | China |
| Daping Hospital of the Third Military Medical University | Chongqing | 400042 | China |
| Shanghai First People's Hospital | Shanghai | 200080 | China |
| ID | Term |
|---|---|
| D008268 | Macular Degeneration |
| D020256 | Choroidal Neovascularization |
| ID | Term |
|---|---|
| D012162 | Retinal Degeneration |
| D012164 | Retinal Diseases |
| D005128 | Eye Diseases |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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