Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The primary objective of this study is to examine effects of fosbretabulin tromethamine (fosbretabulin) on PCV as reflected by a change from baseline in the number of polypoid lesions on indocyanine green angiography (ICGA).
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | single dose |
|
| 15 mg/m^2 | Experimental | 15 mg/m^2 fosbretabulin, single dose |
|
| 25 mg/m^2 | Experimental | 25 mg/m^2 fosbretabulin, single dose |
|
| 35 mg/m^2 | Experimental | 35 mg/m^2 fosbretabulin, single dose |
|
| 45 mg/m^2 | Experimental | 45 mg/m^2 fosbretabulin, single dose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fosbretabulin | Drug | single dose, intravenous infusion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2 | from baseline to Day 2 | |
| Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8 | from baseline to Day 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2 | baseline to Day 2 | |
| Evaluate the change in the area of branching vascular network of PCV on ICGA from baseline to Day 8 | baseline to Day 8 |
Not provided
Inclusion Criteria
Ophthalmologic Exclusion Criteria
Medical Exclusion Criteria
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| OXiGENE Investigational Site | Los Angeles | California | United States | |||
| OXiGENE Investigational Site |
Not provided
Not provided
Not provided
Not provided
Not provided
| Saline | Drug | single dose, intravenous infusion |
|
| Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA) | Day 29 |
| Hong Kong |
| Hong Kong |
| OXiGENE Investigational Site | Singapore | Singapore |
| OXiGENE Investigational Site | Seoul | South Korea |
| OXiGENE Investigational Site | Changhua | Taiwan |
| ID | Term |
|---|---|
| D000092342 | Polypoidal Choroidal Vasculopathy |
| ID | Term |
|---|---|
| D020256 | Choroidal Neovascularization |
| D015862 | Choroid Diseases |
| D014603 | Uveal Diseases |
| D005128 | Eye Diseases |
| D009389 | Neovascularization, Pathologic |
| D008679 | Metaplasia |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C058728 | fosbretabulin |
| C040105 | combretastatin |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |
Not provided
Not provided