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

Mateon Therapeutics

Status and phase: Completed; Phase 2

Conditions: Polypoidal Choroidal Vasculopathy

Treatments: Drug: Saline; Drug: fosbretabulin

Study type: Interventional

Funder types: Industry

Identifiers

NCT01023295

OXC402-201

Details and patient eligibility

About

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).

Enrollment: 20 patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

---

20 participants in 5 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

single dose

Treatment:

Drug: Saline

15 mg/m^2

Experimental group

Description:

15 mg/m\^2 fosbretabulin, single dose

Treatment:

Drug: fosbretabulin

25 mg/m^2

Experimental group

Description:

25 mg/m\^2 fosbretabulin, single dose

Treatment:

Drug: fosbretabulin

35 mg/m^2

Experimental group

Description:

35 mg/m\^2 fosbretabulin, single dose

Treatment:

Drug: fosbretabulin

45 mg/m^2

Experimental group

Description:

45 mg/m\^2 fosbretabulin, single dose

Treatment:

Drug: fosbretabulin