Back to results

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

Primary Purpose

Polypoidal Choroidal Vasculopathy

Status

Completed

Phase

Phase 2

Locations

International

Study Type

Interventional

Intervention

fosbretabulin

Saline

About this trial

This is an interventional treatment trial for Polypoidal Choroidal Vasculopathy focused on measuring Polypoidal Choroidal Vasculopathy, PCV, Polypoid, oxigene, VDA, vascular disrupting agent, combretastatin, fosbretabulin

Eligibility Criteria

21 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

OXiGENE Investigational Site
OXiGENE Investigational Site
OXiGENE Investigational Site
OXiGENE Investigational Site
OXiGENE Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

15 mg/m^2

25 mg/m^2

35 mg/m^2

45 mg/m^2

Arm Description

single dose

15 mg/m^2 fosbretabulin, single dose

25 mg/m^2 fosbretabulin, single dose

35 mg/m^2 fosbretabulin, single dose

45 mg/m^2 fosbretabulin, single dose

Outcomes

Primary Outcome Measures

Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2

Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8

Secondary Outcome Measures

Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2

Evaluate the change in the area of branching vascular network of PCV on ICGA from baseline to Day 8

Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA)

Full Information

NCT ID

NCT01023295

First Posted

November 30, 2009

Last Updated

October 28, 2011

Sponsor

Mateon Therapeutics

1. Study Identification

Unique Protocol Identification Number

NCT01023295

Brief Title

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

Official 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)

Study Type

Interventional

2. Study Status

Record Verification Date

October 2011

Overall Recruitment Status

Completed

Study Start Date

July 2009 (undefined)

Primary Completion Date

August 2010 (Actual)

Study Completion Date

August 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Mateon Therapeutics

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief 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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Polypoidal Choroidal Vasculopathy

Keywords

Polypoidal Choroidal Vasculopathy, PCV, Polypoid, oxigene, VDA, vascular disrupting agent, combretastatin, fosbretabulin

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

single dose

Arm Title

15 mg/m^2

Arm Type

Experimental

Arm Description

15 mg/m^2 fosbretabulin, single dose

Arm Title

25 mg/m^2

Arm Type

Experimental

Arm Description

25 mg/m^2 fosbretabulin, single dose

Arm Title

35 mg/m^2

Arm Type

Experimental

Arm Description

35 mg/m^2 fosbretabulin, single dose

Arm Title

45 mg/m^2

Arm Type

Experimental

Arm Description

45 mg/m^2 fosbretabulin, single dose

Intervention Type

Drug

Intervention Name(s)

fosbretabulin

Other Intervention Name(s)

combretastatin, CA4P

Intervention Description

single dose, intravenous infusion

Intervention Type

Drug

Intervention Name(s)

Saline

Intervention Description

single dose, intravenous infusion

Primary Outcome Measure Information:

Title

Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2

Time Frame

from baseline to Day 2

Title

Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8

Time Frame

from baseline to Day 8

Secondary Outcome Measure Information:

Title

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

Title

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

Title

Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA)

Time Frame

Day 29

10. Eligibility

Sex

All

Minimum Age & Unit of Time

21 Years

Accepts Healthy Volunteers

Eligibility 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.

Facility Information:

Facility Name

OXiGENE Investigational Site

City

Los Angeles

State/Province

California

Country

United States

Facility Name

OXiGENE Investigational Site

City

Hong Kong

Country

Hong Kong

Facility Name

OXiGENE Investigational Site

City

Seoul

Country

Korea, Republic of

Facility Name

OXiGENE Investigational Site

City

Singapore

Country

Singapore

Facility Name

OXiGENE Investigational Site

City

Changhua

Country

Taiwan

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs