Clinical trial NCT01023295: Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients With Polypoidal Choroidal Vasculopathy (PCV)
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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Polypoidal Choroidal Vasculopathy
Keywords: Polypoidal Choroidal Vasculopathy
PCV
Polypoid
oxigene
VDA
vascular disrupting agent
combretastatin
fosbretabulin
Lead sponsor: Mateon Therapeutics
Sponsor class: INDUSTRY
First posted: 2009-12-02
Enrollment: 20
Sex: ALL
Minimum age (years): 21
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2
timeFrame: from baseline to Day 2
measure: Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8
timeFrame: from baseline to Day 8
Secondary outcomes:
measure: Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2
timeFrame: baseline to Day 2
measure: Evaluate the change in the area of branching vascular network of PCV on ICGA from baseline to Day 8
timeFrame: baseline to Day 8
measure: Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA)
timeFrame: Day 29
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: OXiGENE Investigational Site
state: California
city: Hong Kong
country: Hong Kong
facility: OXiGENE Investigational Site
city: Seoul
country: Korea, Republic of
facility: OXiGENE Investigational Site
city: Singapore
country: Singapore
facility: OXiGENE Investigational Site
city: Changhua
country: Taiwan
facility: OXiGENE Investigational Site
Study officials:
References: