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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
20

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2009

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
August 1, 2010

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 30, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
December 1, 2009

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
December 2, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
November 1, 2011

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 28, 2011

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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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