Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients With Polypoidal Choroidal Vasculopathy (PCV)
Phase 2
Completed
- Conditions
- Polypoidal Choroidal Vasculopathy
- Interventions
- Drug: Saline
- Registration Number
- NCT01023295
- Lead Sponsor
- Mateon Therapeutics
- Brief Summary
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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
Not provided
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Saline single dose 15 mg/m^2 fosbretabulin 15 mg/m\^2 fosbretabulin, single dose 25 mg/m^2 fosbretabulin 25 mg/m\^2 fosbretabulin, single dose 35 mg/m^2 fosbretabulin 35 mg/m\^2 fosbretabulin, single dose 45 mg/m^2 fosbretabulin 45 mg/m\^2 fosbretabulin, single dose
- Primary Outcome Measures
Name Time Method 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
- Secondary Outcome Measures
Name Time Method 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 Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA) Day 29
Trial Locations
- Locations (1)
OXiGENE Investigational Site
🇨🇳Changhua, Taiwan