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

Completed · Phase 2 · Has a placebo group

Conditions studied: Polypoidal Choroidal Vasculopathy

In brief

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).

Key facts

Study ID

NCT01023295

Run by

Mateon Therapeutics

People needed

20

Starts

2009-07-01

Expected to finish

2010-08-01

Last updated by the study team

2011-11-01

Who can join

Age: 21 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

Where it is running

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

Full record on ClinicalTrials.gov

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