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

NCT ID: NCT01023295

Last Updated: 2011-11-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-07-31

Study Completion Date

2010-08-31

Brief Summary

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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

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Conditions

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Polypoidal Choroidal Vasculopathy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

single dose

Group Type PLACEBO_COMPARATOR

Saline

Intervention Type DRUG

single dose, intravenous infusion

15 mg/m^2

15 mg/m\^2 fosbretabulin, single dose

Group Type EXPERIMENTAL

fosbretabulin

Intervention Type DRUG

single dose, intravenous infusion

25 mg/m^2

25 mg/m\^2 fosbretabulin, single dose

Group Type EXPERIMENTAL

fosbretabulin

Intervention Type DRUG

single dose, intravenous infusion

35 mg/m^2

35 mg/m\^2 fosbretabulin, single dose

Group Type EXPERIMENTAL

fosbretabulin

Intervention Type DRUG

single dose, intravenous infusion

45 mg/m^2

45 mg/m\^2 fosbretabulin, single dose

Group Type EXPERIMENTAL

fosbretabulin

Intervention Type DRUG

single dose, intravenous infusion

Interventions

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fosbretabulin

single dose, intravenous infusion

Intervention Type DRUG

Saline

single dose, intravenous infusion

Intervention Type DRUG

Other Intervention Names

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combretastatin CA4P

Eligibility Criteria

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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.

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.


* Current or history within two years of any significant heart disease.
* Uncontrolled hypertension.
Minimum Eligible Age

21 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mateon Therapeutics

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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OXiGENE Investigational Site

Los Angeles, California, United States

Site Status

OXiGENE Investigational Site

Hong Kong, , Hong Kong

Site Status

OXiGENE Investigational Site

Singapore, , Singapore

Site Status

OXiGENE Investigational Site

Seoul, , South Korea

Site Status

OXiGENE Investigational Site

Changhua, , Taiwan

Site Status

Countries

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United States Hong Kong Singapore South Korea Taiwan

Other Identifiers

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OXC402-201

Identifier Type: -

Identifier Source: org_study_id