Ignite Creation Date:
2025-12-24 @ 11:08 PM
Ignite Modification Date:
2026-01-19 @ 1:45 PM
Study NCT ID:
NCT00569569
Status:
COMPLETED
Last Update Posted:
2007-12-07
First Post:
2007-12-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retaane® in Age-Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-12', 'completionDateStruct': {'date': '2007-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2007-12-06', 'studyFirstSubmitDate': '2007-12-05', 'studyFirstSubmitQcDate': '2007-12-06', 'lastUpdatePostDateStruct': {'date': '2007-12-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-12-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Increase in VA', 'timeFrame': '6 months'}], 'secondaryOutcomes': [{'measure': 'Decrease in Macula Edema', 'timeFrame': '6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The treatment of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration currently presents a great challenge. With visual loss threatening, there are only very few therapeutic options.\n\nWhile these patients are neither suitable for laser therapy nor for photodynamic therapy with Verteporfin, antiangiogenic drugs applied intravitreally are now available.\n\nSome patients however reject this therapeutic option because of potential complications such as endophthalmitis and the frequency of necessary injections. 20 patients who rejected intravitreal therapy were treated with Anecortave acetate (Retaane®) which was applied as a juxtascleral depot injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '20 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* rejection of intravitreal injections\n* presence of fibrotic choroidal neovascular lesions with presence of residual peripheral activity in age related macular degeneration\n\nExclusion Criteria:\n\n* conditions precluding judgement of the fundus'}, 'identificationModule': {'nctId': 'NCT00569569', 'briefTitle': 'Retaane® in Age-Related Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Rudolf Foundation Clinic'}, 'officialTitle': 'Retaane® in Age-Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'RFC012007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients treated with Retaane', 'interventionNames': ['Drug: juxtascleral depot injection of Retaane']}], 'interventions': [{'name': 'juxtascleral depot injection of Retaane', 'type': 'DRUG', 'description': 'juxtascleral depot injection of Retaane', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Susanne Binder, M.D.', 'role': 'STUDY_CHAIR', 'affiliation': 'no affiliation'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rudolf Foundation Clinic', 'class': 'OTHER'}}}}