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Completed

NCT Number: NCT01023295

Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients 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).

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Key information

Age range

21 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

OXiGENE Investigational Site, Hong Kong

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

fosbretabulin

Drug

single dose, intravenous infusion

Other names: combretastatin, CA4P

Saline

Drug

single dose, intravenous infusion

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Mateon Therapeutics

Industry

Registry information

Official study 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)

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Dec 2, 2009
Registry last updated
Nov 1, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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