Ignite Creation Date:
2025-12-24 @ 1:53 PM
Ignite Modification Date:
2025-12-27 @ 10:10 PM
Study NCT ID:
NCT01023295
Status:
COMPLETED
Last Update Posted:
2011-11-01
First Post:
2009-11-30
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients With Polypoidal Choroidal Vasculopathy (PCV)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000092342', 'term': 'Polypoidal Choroidal Vasculopathy'}], 'ancestors': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C058728', 'term': 'fosbretabulin'}, {'id': 'C040105', 'term': 'combretastatin'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], 'ancestors': [{'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2011-10', 'dispFirstSubmitDate': '2011-10-28', 'completionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2011-10-28', 'studyFirstSubmitDate': '2009-11-30', 'dispFirstSubmitQcDate': '2011-10-28', 'studyFirstSubmitQcDate': '2009-12-01', 'dispFirstPostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2011-11-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2009-12-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate change in number of polypoid lesions on ICGA from baseline to Day 2', 'timeFrame': 'from baseline to Day 2'}, {'measure': 'Evaluate change in the number of polypoid lesions on ICGA from baseline to Day 8', 'timeFrame': 'from baseline to Day 8'}], 'secondaryOutcomes': [{'measure': 'Evaluate the change in area of the branching vascular network of PCV using ICGA from baseline to Day 2', 'timeFrame': 'baseline to Day 2'}, {'measure': 'Evaluate the change in the area of branching vascular network of PCV on ICGA from baseline to Day 8', 'timeFrame': 'baseline to Day 8'}, {'measure': 'Examine effects of fosbretabulin on choroidal neovasculariztion (CNV) and total lesion size using fluorescein angiography (FA)', 'timeFrame': 'Day 29'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Polypoidal Choroidal Vasculopathy', 'PCV', 'Polypoid', 'oxigene', 'VDA', 'vascular disrupting agent', 'combretastatin', 'fosbretabulin'], 'conditions': ['Polypoidal Choroidal Vasculopathy']}, 'descriptionModule': {'briefSummary': '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).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Male or female age ≥21 years.\n* Asian race (e.g. Chinese, Japanese, Korean, Thai).\n* Polypoidal choroidal vasculopathy in the study eye\n* Presence of ≥ 1 visible polypoidal varicosity on ICGA.\n* Presence of a measurable branching vascular network\n* BCVA by ETDRS of 68 to 4 letters in the study eye.\n\nOphthalmologic Exclusion Criteria\n\n* Prior treatment with intravitreal or systemic anti-VEGF therapy within 60 days of enrollment.\n* Any other prior treatment for PCV including thermal laser photocoagulation, photodynamic therapy (i.e., verteporfin), or any investigational therapies.\n* Any history of prior retinal or subretinal surgery, transpupillary thermography, radiation, implantation of intravitreal drug delivery device, vitrectomy.\n* Any other intraocular surgery or laser treatment within 90 days or any surgeries planned during the study period.\n* Fibrosis involving ≥50% of the total lesion.\n* Presence of hemorrhage which potentially obscures \\>75% of vascular pathology to be assessed by imaging procedures.\n* Retinal or choroidal vascular disease in study eye due to causes other than PCV, such as uveitis, trauma, or pathologic myopia.\n* Macular edema in either eye due to other causes, such as diabetic retinopathy.\n* Evidence of glaucomatous eye disease, glaucomatous visual field loss.\n* History of allergy to fluorescein or ICG dye.\n\nMedical Exclusion Criteria\n\n* Current or history within two years of any significant heart disease.\n* Uncontrolled hypertension.'}, 'identificationModule': {'nctId': 'NCT01023295', 'briefTitle': 'Study Evaluating the Safety and Response of Fosbretabulin in Asian Patients With Polypoidal Choroidal Vasculopathy (PCV)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Mateon Therapeutics'}, 'officialTitle': '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)', 'orgStudyIdInfo': {'id': 'OXC402-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'single dose', 'interventionNames': ['Drug: Saline']}, {'type': 'EXPERIMENTAL', 'label': '15 mg/m^2', 'description': '15 mg/m\\^2 fosbretabulin, single dose', 'interventionNames': ['Drug: fosbretabulin']}, {'type': 'EXPERIMENTAL', 'label': '25 mg/m^2', 'description': '25 mg/m\\^2 fosbretabulin, single dose', 'interventionNames': ['Drug: fosbretabulin']}, {'type': 'EXPERIMENTAL', 'label': '35 mg/m^2', 'description': '35 mg/m\\^2 fosbretabulin, single dose', 'interventionNames': ['Drug: fosbretabulin']}, {'type': 'EXPERIMENTAL', 'label': '45 mg/m^2', 'description': '45 mg/m\\^2 fosbretabulin, single dose', 'interventionNames': ['Drug: fosbretabulin']}], 'interventions': [{'name': 'fosbretabulin', 'type': 'DRUG', 'otherNames': ['combretastatin', 'CA4P'], 'description': 'single dose, intravenous infusion', 'armGroupLabels': ['15 mg/m^2', '25 mg/m^2', '35 mg/m^2', '45 mg/m^2']}, {'name': 'Saline', 'type': 'DRUG', 'description': 'single dose, intravenous infusion', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'OXiGENE Investigational Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'city': 'Hong Kong', 'country': 'Hong Kong', 'facility': 'OXiGENE Investigational Site', 'geoPoint': {'lat': 22.27832, 'lon': 114.17469}}, {'city': 'Singapore', 'country': 'Singapore', 'facility': 'OXiGENE Investigational Site', 'geoPoint': {'lat': 1.28967, 'lon': 103.85007}}, {'city': 'Seoul', 'country': 'South Korea', 'facility': 'OXiGENE Investigational Site', 'geoPoint': {'lat': 37.566, 'lon': 126.9784}}, {'city': 'Changhua', 'country': 'Taiwan', 'facility': 'OXiGENE Investigational Site', 'geoPoint': {'lat': 24.0692, 'lon': 120.5512}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mateon Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}