Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients With Polypoidal Choroidal Vasculopathy (PCV)

Polypoidal Choroidal Vasculopathy Clinical Trial

Official title:

OXiGENE OXC402-201: A Phase 2, Randomized, Double-Masked, Placebo-Controlled Study of the Safety, Pharmacokinetics, and Biological Effects of Intravenous Fosbretabulin in Asian Subjects With Polypoidal Choroidal Vasculopathy (PCV)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01023295
• Other study ID #: OXC402-201
• Status: Completed
• Phase: Phase 2
• First received: November 30, 2009
• Last updated: October 28, 2011
• Start date: July 2009
• Est. completion date: August 2010

Study information

• Verified date: October 2011
• Source: OXiGENE
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug AdministrationHong Kong: Department of HealthKorea: Food and Drug AdministrationSingapore: Health Sciences AuthorityTaiwan: Department of Health
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: August 2010
• Est. primary completion date: August 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 21 Years and older

Eligibility

Inclusion Criteria

• Male or female age =21 years.

• Asian race (e.g. Chinese, Japanese, Korean, Thai).

• Polypoidal choroidal vasculopathy in the study eye

• Presence of = 1 visible polypoidal varicosity on ICGA.

• Presence of a measurable branching vascular network

• BCVA by ETDRS of 68 to 4 letters in the study eye.

Ophthalmologic Exclusion Criteria

• Prior treatment with intravitreal or systemic anti-VEGF therapy within 60 days of enrollment.

• Any other prior treatment for PCV including thermal laser photocoagulation, photodynamic therapy (i.e., verteporfin), or any investigational therapies.

• Any history of prior retinal or subretinal surgery, transpupillary thermography, radiation, implantation of intravitreal drug delivery device, vitrectomy.

• Any other intraocular surgery or laser treatment within 90 days or any surgeries planned during the study period.

• Fibrosis involving =50% of the total lesion.

• Presence of hemorrhage which potentially obscures >75% of vascular pathology to be assessed by imaging procedures.

• Retinal or choroidal vascular disease in study eye due to causes other than PCV, such as uveitis, trauma, or pathologic myopia.

• Macular edema in either eye due to other causes, such as diabetic retinopathy.

• Evidence of glaucomatous eye disease, glaucomatous visual field loss.

• History of allergy to fluorescein or ICG dye.

Medical Exclusion Criteria

• Current or history within two years of any significant heart disease.

• Uncontrolled hypertension.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Polypoidal Choroidal Vasculopathy
• Vascular Diseases

Intervention

Drug:
• fosbretabulin
single dose, intravenous infusion
• Saline
single dose, intravenous infusion

Locations

Country	Name	City	State
Hong Kong	OXiGENE Investigational Site	Hong Kong
Korea, Republic of	OXiGENE Investigational Site	Seoul
Singapore	OXiGENE Investigational Site	Singapore
Taiwan	OXiGENE Investigational Site	Changhua
United States	OXiGENE Investigational Site	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
OXiGENE

Countries where clinical trial is conducted

United States,  Hong Kong,  Korea, Republic of,  Singapore,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2		from baseline to Day 2	No
Primary	Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8		from baseline to Day 8	No
Secondary	Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2		baseline to Day 2	No
Secondary	Evaluate the change in the area of branching vascular network of PCV on ICGA from baseline to Day 8		baseline to Day 8	No
Secondary	Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA)		Day 29	No