Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT01473251
Status:
COMPLETED
Last Update Posted:
2014-12-17
First Post:
2011-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D057135', 'term': 'Wet Macular Degeneration'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069579', 'term': 'Ranibizumab'}], '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': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-12', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-12-16', 'studyFirstSubmitDate': '2011-11-14', 'studyFirstSubmitQcDate': '2011-11-14', 'lastUpdatePostDateStruct': {'date': '2014-12-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2011-11-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of collected vitreous samples to identify biomarkers.', 'timeFrame': 'End of study', 'description': 'Analysis of collected vitreous samples in regards to identification of biomarkers that are prognostic for response to anti-angiogenic treatment of retinopathy, and the exploration of a more effective dosing regiment for intravitreal injections of Lucentis/Avastin for exudative macular degeneration and Avastin for diabetic macular edema.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Exudative Macular Degeneration', 'Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to measure biomarkers in the vitreous of patients undergoing Lucentis or avastin treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age 18 to 85 with diabetes and hemoglobin A1C \\</= 10, or exudative macular degeneration.\n* Diabetic macular edema with average retinal thickness central subfield \\>/= 290um.\n\nExclusion Criteria:\n\n* Macular atrophy/fibrosis.\n* Ocular anti-VEGF treatment within 3 months.\n* Treatment with topical or oral carbonic-anhydrase inhibitor within one month\n* Laser photocoagulation within 3 months (diabetic cohort)'}, 'identificationModule': {'nctId': 'NCT01473251', 'briefTitle': 'Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration', 'organization': {'class': 'OTHER', 'fullName': 'Vitreo-Retinal Associates, Michigan'}, 'officialTitle': 'Analysis of Growth Factors in Patients Undergoing Lucentis or Avastin Injections for Diabetic Macular Edema and Exudative Macular Degeneration', 'orgStudyIdInfo': {'id': 'VARI 2011 002'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Avastin for Diabetic Macular Edema', 'description': '1.25 mg avastin monthly for 4 months', 'interventionNames': ['Drug: Avastin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Avastin for Exudative Macular Degeneration', 'description': '1.25 mg Avastin monthly for 4 months', 'interventionNames': ['Drug: Avastin']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Lucentis for Exudative Macular Degeneration', 'description': '0.5 mg Lucentis monthly for 4 months', 'interventionNames': ['Drug: Lucentis']}], 'interventions': [{'name': 'Avastin', 'type': 'DRUG', 'description': '1.25 mg monthly for 4 months', 'armGroupLabels': ['Avastin for Diabetic Macular Edema']}, {'name': 'Avastin', 'type': 'DRUG', 'description': '1.25 mg monthly for 4 months', 'armGroupLabels': ['Avastin for Exudative Macular Degeneration']}, {'name': 'Lucentis', 'type': 'DRUG', 'description': '0.5 mg monthly for 4 months', 'armGroupLabels': ['Lucentis for Exudative Macular Degeneration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '49525', 'city': 'Grand Rapids', 'state': 'Michigan', 'country': 'United States', 'facility': 'Vitreo-Retinal Associates', 'geoPoint': {'lat': 42.96336, 'lon': -85.66809}}], 'overallOfficials': [{'name': 'Louis C. Glazer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Vitreo Retinal Associates'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Vitreo-Retinal Associates, Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'Van Andel Research Institute', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}