Ignite Creation Date:
2025-12-24 @ 6:47 PM
Ignite Modification Date:
2026-01-05 @ 6:15 PM
Study NCT ID:
NCT00346957
Status:
COMPLETED
Last Update Posted:
2012-03-06
First Post:
2006-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, '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': 128}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1999-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-03', 'completionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-03-03', 'studyFirstSubmitDate': '2006-06-28', 'studyFirstSubmitQcDate': '2006-06-30', 'lastUpdatePostDateStruct': {'date': '2012-03-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in logMAR visual acuity at 12 months from baseline.', 'timeFrame': '12 months'}]}, 'conditionsModule': {'conditions': ['AMD']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to determine the concentration of anecortave acetate (15 or 30 mg versus placebo) that is safe and effective for the inhibition of the growth of blood vessels in the retina in patients with wet AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Ages 50 years and over\n* Other protocol-defined inclusion and exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT00346957', 'briefTitle': 'A Phase II Study of Anecortave Acetate for the Treatment of Exudative Age-Related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'orgStudyIdInfo': {'id': 'C-98-03'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Anecortave Acetate 30', 'interventionNames': ['Drug: Anecortave acetate 30 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Anecortave Acetate 15', 'interventionNames': ['Drug: Anecortave Acetate 15 mg']}, {'type': 'EXPERIMENTAL', 'label': 'Anecortave Acetate 3', 'interventionNames': ['Drug: Anecortave Acetate 3 mg']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Anecortave Acetate Vehicle', 'interventionNames': ['Other: Anecortave Acetate Vehicle']}], 'interventions': [{'name': 'Anecortave acetate 30 mg', 'type': 'DRUG', 'description': '0.5ml administered onto the sclera once every six months for 24 months', 'armGroupLabels': ['Anecortave Acetate 30']}, {'name': 'Anecortave Acetate 15 mg', 'type': 'DRUG', 'description': '0.5ml administered onto the sclera once every six months for 24 months', 'armGroupLabels': ['Anecortave Acetate 15']}, {'name': 'Anecortave Acetate 3 mg', 'type': 'DRUG', 'description': '0.5ml administered onto the sclera once every six months for 24 months', 'armGroupLabels': ['Anecortave Acetate 3']}, {'name': 'Anecortave Acetate Vehicle', 'type': 'OTHER', 'description': '0.5ml administered onto the sclera once every six months for 24 months', 'armGroupLabels': ['Anecortave Acetate Vehicle']}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}