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

• Status: Completed
• Trial end date: 2010-08-01
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mateon Therapeutics
• Treatments: Combretastatin; Fosbretabulin

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.