NCT01023295

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).

Trial Health

93
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jul 2009

Shorter than P25 for phase_2

Geographic Reach
5 countries

5 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2009

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2009

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 2, 2009

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
Last Updated

November 1, 2011

Status Verified

October 1, 2011

Enrollment Period

1.1 years

First QC Date

November 30, 2009

Last Update Submit

October 28, 2011

Conditions

Polypoidal Choroidal Vasculopathy

Keywords

Polypoidal Choroidal VasculopathyPCVPolypoidoxigeneVDAvascular disrupting agentcombretastatinfosbretabulin

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (3)

  • 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

Study Arms (5)

Placebo

PLACEBO COMPARATOR

single dose

Drug: Saline

15 mg/m^2

EXPERIMENTAL

15 mg/m\^2 fosbretabulin, single dose

Drug: fosbretabulin

25 mg/m^2

EXPERIMENTAL

25 mg/m\^2 fosbretabulin, single dose

Drug: fosbretabulin

35 mg/m^2

EXPERIMENTAL

35 mg/m\^2 fosbretabulin, single dose

Drug: fosbretabulin

45 mg/m^2

EXPERIMENTAL

45 mg/m\^2 fosbretabulin, single dose

Drug: fosbretabulin

Interventions

fosbretabulinDRUG

single dose, intravenous infusion

Also known as: combretastatin, CA4P
15 mg/m^225 mg/m^235 mg/m^245 mg/m^2
SalineDRUG

single dose, intravenous infusion

Placebo

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

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.

You may not qualify if:

  • 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.
  • Current or history within two years of any significant heart disease.
  • Uncontrolled hypertension.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (5)

OXiGENE Investigational Site

Los Angeles, California, United States

Location

OXiGENE Investigational Site

Hong Kong, Hong Kong

Location

OXiGENE Investigational Site

Singapore, Singapore

Location

OXiGENE Investigational Site

Seoul, South Korea

Location

OXiGENE Investigational Site

Changhua, Taiwan

Location

MeSH Terms

Conditions

Polypoidal Choroidal Vasculopathy

Interventions

fosbretabulincombretastatinSodium Chloride

Condition Hierarchy (Ancestors)

Choroidal NeovascularizationChoroid DiseasesUveal DiseasesEye DiseasesNeovascularization, PathologicMetaplasiaPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

ChloridesHydrochloric AcidChlorine CompoundsInorganic ChemicalsSodium Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2009

First Posted

December 2, 2009

Study Start

July 1, 2009

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

November 1, 2011

Record last verified: 2011-10

Locations

HK(1)TW(1)SG(1)KR(1)US(1)