Ignite Creation Date:
2025-12-26 @ 10:59 AM
Ignite Modification Date:
2026-01-01 @ 5:47 AM
Study NCT ID:
NCT00802906
Status:
COMPLETED
Last Update Posted:
2012-09-27
First Post:
2008-12-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D056833', 'term': 'Central Serous Chorioretinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-09', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-09-26', 'studyFirstSubmitDate': '2008-12-04', 'studyFirstSubmitQcDate': '2008-12-04', 'lastUpdatePostDateStruct': {'date': '2012-09-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'BCVA in EDTRS values', 'timeFrame': '24 months'}], 'secondaryOutcomes': [{'measure': 'OCT, leakage in FA, defects in satic perimetry', 'timeFrame': '24 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['micropulselaserphotocoagulation', 'bevacizumab', 'CSC'], 'conditions': ['Central Serous Chorioretinopathy']}, 'referencesModule': {'references': [{'pmid': '22079961', 'type': 'DERIVED', 'citation': 'Koss MJ, Beger I, Koch FH. Subthreshold diode laser micropulse photocoagulation versus intravitreal injections of bevacizumab in the treatment of central serous chorioretinopathy. Eye (Lond). 2012 Feb;26(2):307-14. doi: 10.1038/eye.2011.282. Epub 2011 Nov 11.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells, whereas the intravitreal injection should non-selectively stop the RPE leakage.', 'detailedDescription': 'To evaluate the clinical efficacy of an initial subthreshold retinal micropulselasercoagulation in twelve eyey per group versus a single intravitreal 1.5mg bevacizumab injection in central serous choriretinopathy, as the micropulse will selectively treat the damaged RPE to induce reproliferation of healthy RPE cells. BCVA in EDTRS score, OCT, and leakage in FLA, static perimetry of both groups will be correlated to a control group without treatment over 10 months.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '21 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria:\n\n* CSC of \\>4 months duration\n\nExclusion Criteria:\n\n* History of macular or chorioretinal inflammation\n* Lens / corneal opacities'}, 'identificationModule': {'nctId': 'NCT00802906', 'briefTitle': 'Bevacizumab Versus Micropulse in Central Serous Chorioretinopathy (CSC)', 'organization': {'class': 'OTHER', 'fullName': 'Johann Wolfgang Goethe University Hospital'}, 'officialTitle': 'Prospective Study on the Efficacy of 1.5mg Bevacizumab Versus Selective Subthreshold Micropulslaser in Central Serous Chorioretinopathy', 'orgStudyIdInfo': {'id': 'MK-RCS-2008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': '1', 'description': '1.5 mg bevacizumab single injection and on demand if leakage is persistent or recurs', 'interventionNames': ['Device: subthreshold micropulselaser', 'Drug: bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': '2', 'description': 'initial selective subthreshold micropulselasercoagulation and on demand if leakage is persistent or recurs', 'interventionNames': ['Device: subthreshold micropulselaser']}, {'type': 'NO_INTERVENTION', 'label': '3', 'description': 'control'}], 'interventions': [{'name': 'subthreshold micropulselaser', 'type': 'DEVICE', 'description': 'on demand if leakage is persistent or recurs after initial treatment', 'armGroupLabels': ['1', '2']}, {'name': 'bevacizumab', 'type': 'DRUG', 'description': '1.5 mg initial intravitreal injection', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60590', 'city': 'Frankfurt am Main', 'state': 'Hesse', 'country': 'Germany', 'facility': 'ZAU Department of VR surgery', 'geoPoint': {'lat': 50.11552, 'lon': 8.68417}}], 'overallOfficials': [{'name': 'Michael Koss, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'ZAU Department of Vitreoretinal surgery'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Johann Wolfgang Goethe University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Michael Koss', 'investigatorAffiliation': 'Johann Wolfgang Goethe University Hospital'}}}}