Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT00320203
Status:
COMPLETED
Last Update Posted:
2012-11-28
First Post:
2006-05-01
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Anecortave Acetate in Patients With Open-angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C418047', 'term': 'anecortave acetate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-02', 'dispFirstSubmitDate': '2012-11-27', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2006-05-01', 'dispFirstSubmitQcDate': '2012-11-27', 'studyFirstSubmitQcDate': '2006-05-01', 'dispFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-05-03', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in intraocular pressure at 9 am from baseline', 'timeFrame': 'Weeks 2 and 6, Months 2, 3, 4, 5, 6, 7.5, 9, 10.5, and 12'}], 'secondaryOutcomes': [{'measure': 'Time to treatment failure', 'timeFrame': 'At time point'}]}, 'conditionsModule': {'keywords': ['open-angle', 'glaucoma'], 'conditions': ['Open-angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the safety, efficacy, and duration of effect of a single administration of Anecortave Acetate Depot for treatment of elevated intraocular pressure (IOP) in patients with open-angle glaucoma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients 18 years of age or older with open-angle glaucoma.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Patients with open-angle glaucoma with a pseudoexfoliation or pigment dispersion component.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00320203', 'briefTitle': 'Anecortave Acetate in Patients With Open-angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'A Study of the Safety and IOP-Lowering Efficacy of Anecortave Acetate in Patients With Open-Angle Glaucoma', 'orgStudyIdInfo': {'id': 'C-04-62'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anecortave Acetate 3 mg Depot', 'description': 'Single injection, anterior juxtascleral depot (AJD)', 'interventionNames': ['Drug: Anecortave Acetate Sterile Suspension, 6 mg/mL']}, {'type': 'EXPERIMENTAL', 'label': 'Anecortave Acetate 15 mg Depot', 'description': 'Single injection, anterior juxtascleral depot (AJD)', 'interventionNames': ['Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL']}, {'type': 'EXPERIMENTAL', 'label': 'Anecortave Acetate 30 mg Depot', 'description': 'Single injection, anterior juxtascleral depot (AJD)', 'interventionNames': ['Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL']}, {'type': 'OTHER', 'label': 'Anecortave Acetate Vehicle', 'description': 'Single injection, anterior juxtascleral depot (AJD)', 'interventionNames': ['Other: Anecortave Acetate Vehicle']}], 'interventions': [{'name': 'Anecortave Acetate Sterile Suspension, 6 mg/mL', 'type': 'DRUG', 'description': 'Single injection, anterior juxtascleral depot (AJD)', 'armGroupLabels': ['Anecortave Acetate 3 mg Depot']}, {'name': 'Anecortave Acetate Sterile Suspension, 30 mg/mL', 'type': 'DRUG', 'description': 'Single injection, anterior juxtascleral depot (AJD)', 'armGroupLabels': ['Anecortave Acetate 15 mg Depot']}, {'name': 'Anecortave Acetate Sterile Suspension, 60 mg/mL', 'type': 'DRUG', 'description': 'Single injection, anterior juxtascleral depot (AJD)', 'armGroupLabels': ['Anecortave Acetate 30 mg Depot']}, {'name': 'Anecortave Acetate Vehicle', 'type': 'OTHER', 'description': 'Single injection, anterior juxtascleral depot (AJD)', 'armGroupLabels': ['Anecortave Acetate Vehicle']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Theresa Landry', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}