Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01023295
Recruitment Status : Completed
First Posted : December 2, 2009
Last Update Posted : November 1, 2011
Sponsor:
Information provided by (Responsible Party):
Mateon Therapeutics

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).

Condition or disease Intervention/treatment Phase
Polypoidal Choroidal Vasculopathy Drug: fosbretabulin Drug: Saline Phase 2

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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 Start Date : July 2009
Actual Primary Completion Date : August 2010
Actual Study Completion Date : August 2010

Resource links provided by the National Library of Medicine


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:
  • combretastatin
  • CA4P

Experimental: 25 mg/m^2
25 mg/m^2 fosbretabulin, single dose
Drug: fosbretabulin
single dose, intravenous infusion
Other Names:
  • combretastatin
  • CA4P

Experimental: 35 mg/m^2
35 mg/m^2 fosbretabulin, single dose
Drug: fosbretabulin
single dose, intravenous infusion
Other Names:
  • combretastatin
  • CA4P

Experimental: 45 mg/m^2
45 mg/m^2 fosbretabulin, single dose
Drug: fosbretabulin
single dose, intravenous infusion
Other Names:
  • combretastatin
  • CA4P




Primary Outcome Measures :
  1. Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2 [ Time Frame: from baseline to Day 2 ]
  2. Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8 [ Time Frame: from baseline to Day 8 ]

Secondary Outcome Measures :
  1. 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 ]
  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 ]
  3. Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA) [ Time Frame: Day 29 ]


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01023295


Locations
Layout table for location information
United States, California
OXiGENE Investigational Site
Los Angeles, California, United States
Hong Kong
OXiGENE Investigational Site
Hong Kong, Hong Kong
Korea, Republic of
OXiGENE Investigational Site
Seoul, Korea, Republic of
Singapore
OXiGENE Investigational Site
Singapore, Singapore
Taiwan
OXiGENE Investigational Site
Changhua, Taiwan
Sponsors and Collaborators
Mateon Therapeutics

Layout table for additonal information
Responsible Party: Mateon Therapeutics
ClinicalTrials.gov Identifier: NCT01023295     History of Changes
Other Study ID Numbers: OXC402-201
First Posted: December 2, 2009    Key Record Dates
Last Update Posted: November 1, 2011
Last Verified: October 2011

Keywords provided by Mateon Therapeutics:
Polypoidal Choroidal Vasculopathy
PCV
Polypoid
oxigene
VDA
vascular disrupting agent
combretastatin
fosbretabulin

Additional relevant MeSH terms:
Layout table for MeSH terms
Vascular Diseases
Cardiovascular Diseases
Fosbretabulin
Combretastatin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action