Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2025-12-29 @ 3:35 PM
Study NCT ID:
NCT00332657
Status:
TERMINATED
Last Update Posted:
2012-11-28
First Post:
2006-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anecortave Acetate Risk Reduction Trial (AART)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C418047', 'term': 'anecortave acetate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 36}}, 'statusModule': {'whyStopped': 'Management Decision', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2006-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-09', 'dispFirstSubmitDate': '2012-11-27', 'completionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-27', 'studyFirstSubmitDate': '2006-05-31', 'dispFirstSubmitQcDate': '2012-11-27', 'studyFirstSubmitQcDate': '2006-05-31', 'dispFirstPostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'lastUpdatePostDateStruct': {'date': '2012-11-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of patients with sight-threatening choroidal neovascularization (CNV) in study eye', 'timeFrame': 'Month 48'}], 'secondaryOutcomes': [{'measure': 'Time to development of sight-threatening CNV', 'timeFrame': 'Timepoint'}]}, 'conditionsModule': {'conditions': ['AMD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to demonstrate that Anecortave Acetate for Depot Suspension (15 mg or 30 mg) is safe and effective in arresting the progression of dry age-related macular degeneration (AMD) in patients who are at-risk for progressing to wet AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Dry AMD in study eye, Wet AMD non-study eye.\n* Other protocol-defined inclusion criteria may apply.\n\nExclusion Criteria:\n\n* Under 50.\n* Other protocol-defined exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00332657', 'briefTitle': 'Anecortave Acetate Risk Reduction Trial (AART)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-05-34'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anecortave Acetate, 15 mg', 'description': 'One 0.5 mL injection of 30 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.', 'interventionNames': ['Drug: Anecortave Acetate Sterile Suspension, 30 mg/mL']}, {'type': 'EXPERIMENTAL', 'label': 'Anecortave Acetate, 30 mg', 'description': 'One 0.5 mL injection of 60 mg/mL Anecortave Acetate Sterile Suspension into the posterior juxtascleral depot (PJD) at 6-month intervals for 42 months.', 'interventionNames': ['Drug: Anecortave Acetate Sterile Suspension, 60 mg/mL']}, {'type': 'SHAM_COMPARATOR', 'label': 'Anecortave Acetate Vehicle', 'description': 'One sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.', 'interventionNames': ['Other: Anecortave Acetate Vehicle']}], 'interventions': [{'name': 'Anecortave Acetate Sterile Suspension, 30 mg/mL', 'type': 'DRUG', 'description': 'One 0.5 mL injection into the PJD at 6-month intervals for 42 months', 'armGroupLabels': ['Anecortave Acetate, 15 mg']}, {'name': 'Anecortave Acetate Sterile Suspension, 60 mg/mL', 'type': 'DRUG', 'description': 'One 0.5 mL injection into the PJD at 6-month intervals for 42 months', 'armGroupLabels': ['Anecortave Acetate, 30 mg']}, {'name': 'Anecortave Acetate Vehicle', 'type': 'OTHER', 'description': 'One 0.5 mL sham injection at 6-month intervals for 42 months. Syringe and vehicle were not inserted into the eye.', 'armGroupLabels': ['Anecortave Acetate Vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76134', 'city': 'Bangalore', 'country': 'India', 'facility': 'India', 'geoPoint': {'lat': 12.97194, 'lon': 77.59369}}], 'overallOfficials': [{'name': 'Terry Wiernas, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Study Director'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}