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

October 28, 2011 updated by: Mateon Therapeutics

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)

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Hong Kong
      • Hong Kong, Hong Kong
        • OXiGENE Investigational Site
  • Korea, Republic of
      • Seoul, Korea, Republic of
        • OXiGENE Investigational Site
  • Singapore
      • Singapore, Singapore
        • OXiGENE Investigational Site
  • Taiwan
      • Changhua, Taiwan
        • OXiGENE Investigational Site
  • United States
    • California
      • Los Angeles, California, United States
        • OXiGENE Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
PLACEBO_COMPARATOR: Placebo
single dose
Drug: Saline
single dose, intravenous infusion
EXPERIMENTAL: 15 mg/m^2
15 mg/m^2 fosbretabulin, single dose
Drug: fosbretabulin
single dose, intravenous infusion
Other Names:
  • CA4P
  • combretastatin
EXPERIMENTAL: 25 mg/m^2
25 mg/m^2 fosbretabulin, single dose
Drug: fosbretabulin
single dose, intravenous infusion
Other Names:
  • CA4P
  • combretastatin
EXPERIMENTAL: 35 mg/m^2
35 mg/m^2 fosbretabulin, single dose
Drug: fosbretabulin
single dose, intravenous infusion
Other Names:
  • CA4P
  • combretastatin
EXPERIMENTAL: 45 mg/m^2
45 mg/m^2 fosbretabulin, single dose
Drug: fosbretabulin
single dose, intravenous infusion
Other Names:
  • CA4P
  • combretastatin

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2
Time Frame: 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
Time Frame: from baseline to Day 8
from baseline to Day 8

Secondary Outcome Measures

Outcome Measure
Time Frame
Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2
Time Frame: 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
Time Frame: baseline to Day 8
baseline to Day 8
Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA)
Time Frame: Day 29
Day 29

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mateon Therapeutics

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2009

Primary Completion (ACTUAL)

August 1, 2010

Study Completion (ACTUAL)

August 1, 2010

Study Registration Dates

First Submitted

November 30, 2009

First Submitted That Met QC Criteria

December 1, 2009

First Posted (ESTIMATE)

December 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

November 1, 2011

Last Update Submitted That Met QC Criteria

October 28, 2011

Last Verified

October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OXC402-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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