Ignite Creation Date:
2025-12-24 @ 11:45 AM
Ignite Modification Date:
2026-01-06 @ 2:21 AM
Study NCT ID:
NCT00751361
Status:
COMPLETED
Last Update Posted:
2008-09-11
First Post:
2008-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D010956', 'term': 'Plasmapheresis'}], 'ancestors': [{'id': 'D001781', 'term': 'Blood Component Removal'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D016060', 'term': 'Sorption Detoxification'}, {'id': 'D005112', 'term': 'Extracorporeal Circulation'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1998-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-09', 'completionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-09-10', 'studyFirstSubmitDate': '2008-09-10', 'studyFirstSubmitQcDate': '2008-09-10', 'lastUpdatePostDateStruct': {'date': '2008-09-11', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2003-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The primary outcome is change in best corrected ETDRS-visual acuity (mean logMar change) after 7.5 months compared to baseline visual acuity for both groups.', 'timeFrame': '30 weeks (7.5 months)'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Rheopheresis', 'Dry Age Related Macular Degeneration', 'AMD', 'apheresis', 'microcirculation'], 'conditions': ['Dry Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Purpose is to evaluate Rheopheresis for the treatment of patients with high-risk dry age-related macular degeneration and no therapeutic alternative. Rheopheresis is a method of therapeutic apheresis using the methodology of double filtration plasmapheresis to treat microcirculatory disorders.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 to 85 years old\n* diagnosis of AMD in both eyes\n* must have dry AMD in the study eye\n* Study eyes with best-corrected ETDRS-visual acuity of 0.1-0.8\n* peripheral veins allowing vascular access to establish the extracorporal circuit.\n\nExclusion Criteria:\n\n* other retinal or choroidal disorders than AMD\n* optic nerve disease, glaucoma\n* conditions that limit the view of the fundus\n* acute bleeding in any eye\n\nGeneral exclusion criteria for the treatment of Rheopheresis:\n\n* anaemia\n* haemorrhagic diathesis or coagulopathy\n* diabetes\n* serious acute or chronic kidney or liver failure\n* hypotension systolic \\< 100 mmHg\n* chronic viral infection (HIV, hepatitis B, C)\n* epilepsia, psychosis or dementia\n* a malignant disease or any other condition with life expectancy \\< 12 months\n* known history of alcohol or drug abuse and long term serious nicotine abuse'}, 'identificationModule': {'nctId': 'NCT00751361', 'acronym': 'ART', 'briefTitle': 'Dry Age-Related Macular Degeneration (AMD) Treatment With Rheopheresis Trial', 'organization': {'class': 'OTHER', 'fullName': 'Apheresis Research Institute'}, 'officialTitle': 'Prospective, Randomized, Controlled Clinical Study Evaluating the Efficacy of Rheopheresis for Dry Age-Related Macular Degeneration Dry AMD Treatment With Rheopheresis Trial - ART', 'orgStudyIdInfo': {'id': 'AR-2000'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': 'Treatment group: Patients receive 10 Rheopheresis treatments within 17 weeks', 'interventionNames': ['Device: Rheopheresis / double filtration plasmapheresis']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'No treatment control group'}], 'interventions': [{'name': 'Rheopheresis / double filtration plasmapheresis', 'type': 'DEVICE', 'otherNames': ['Rheopheresis', 'Double filtration plasmapheresis'], 'description': 'Rheopheresis is a specific method of therapeutic apheresis, using the methodology of double filtration plasmapheresis.', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt', 'country': 'Germany', 'facility': 'University of Frankfurt Department of Ophthalmology', 'geoPoint': {'lat': 49.68333, 'lon': 10.53333}}], 'overallOfficials': [{'name': 'Frank HJ Koch, Prof. Dr.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Frankfurt'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Apheresis Research Institute', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Reinhard Klingel, Prof. Dr.', 'oldOrganization': 'Apheresis Research Institute'}}}}