Ignite Creation Date:
2025-12-24 @ 4:27 PM
Ignite Modification Date:
2026-01-02 @ 3:06 AM
Study NCT ID:
NCT00346866
Status:
COMPLETED
Last Update Posted:
2008-08-05
First Post:
2006-06-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Anecortave Acetate Versus Placebo in AMD Patients Following PDT
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C418047', 'term': 'anecortave acetate'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'count': 136}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2000-05'}, 'statusVerifiedDate': '2008-08', 'completionDateStruct': {'date': '2001-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-08-04', 'studyFirstSubmitDate': '2006-06-28', 'studyFirstSubmitQcDate': '2006-06-28', 'lastUpdatePostDateStruct': {'date': '2008-08-05', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-06-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2001-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change from the baseline in logMAR visual acuity score at Month 6'}], 'secondaryOutcomes': [{'measure': '% patients who maintained vision, number of months of angiographic evidence of needing PDT re-treatment, and mean lesion sizes for the total choroidal neovascularization (CNV) and the classic component to the total CNV.'}]}, 'conditionsModule': {'conditions': ['AMD']}, 'descriptionModule': {'briefSummary': 'The purpose of this study was to evaluate the efficacy of anecortave acetate for depot suspension (30 mg and 15 mg) plus PDT versus PDT alone with respect to maintenance of visual acuity in patients with wet AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* AMD disease\n\nExclusion Criteria:\n\n* Age'}, 'identificationModule': {'nctId': 'NCT00346866', 'briefTitle': 'Anecortave Acetate Versus Placebo in AMD Patients Following PDT', 'organization': {'class': 'INDUSTRY', 'fullName': 'Alcon Research'}, 'officialTitle': 'Anecortave Acetate Versus Placebo in AMD Patients Following PDT', 'orgStudyIdInfo': {'id': 'C-00-07'}}, 'armsInterventionsModule': {'interventions': [{'name': 'anecortave acetate', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Facility', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}], 'overallOfficials': [{'name': 'Patricia Zilliox', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Alcon Research'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Alcon Research', 'class': 'INDUSTRY'}}}}