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

Study Overview
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Brief Summary
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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).

Official Title
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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)

Conditions
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Polypoidal Choroidal Vasculopathy

Intervention / Treatment
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* Drug: fosbretabulin
* Drug: Saline


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Placebo<br>single dose | Drug: Saline<br>* single dose, intravenous infusion<br>|
| Experimental: 15 mg/m^2<br>15 mg/m^2 fosbretabulin, single dose | Drug: fosbretabulin<br>* single dose, intravenous infusion<br>* Other names: CA4P;|
| Experimental: 25 mg/m^2<br>25 mg/m^2 fosbretabulin, single dose | Drug: fosbretabulin<br>* single dose, intravenous infusion<br>* Other names: CA4P;|
| Experimental: 35 mg/m^2<br>35 mg/m^2 fosbretabulin, single dose | Drug: fosbretabulin<br>* single dose, intravenous infusion<br>* Other names: CA4P;|
| Experimental: 45 mg/m^2<br>45 mg/m^2 fosbretabulin, single dose | Drug: fosbretabulin<br>* single dose, intravenous infusion<br>* Other names: CA4P;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2 |  | from baseline to Day 2 | 
| Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8 |  | from baseline to Day 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2 |  | baseline to Day 2 | 
| Evaluate the change in the area of branching vascular network of PCV on ICGA from baseline to Day 8 |  | baseline to Day 8 | 
| Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA) |  | Day 29 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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PCV, Polypoidal Choroidal Vasculopathy, Polypoid, oxigene, VDA, vascular disrupting agent, combretastatin, fosbretabulin