Ignite Creation Date:
2025-12-25 @ 12:15 AM
Ignite Modification Date:
2026-02-28 @ 5:31 AM
Study NCT ID:
NCT01638858
Status:
COMPLETED
Last Update Posted:
2014-07-08
First Post:
2012-07-02
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)
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'}]}, 'interventionBrowseModule': {'meshes': [{'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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 25}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-07', 'lastUpdateSubmitDate': '2014-07-04', 'studyFirstSubmitDate': '2012-07-02', 'studyFirstSubmitQcDate': '2012-07-09', 'lastUpdatePostDateStruct': {'date': '2014-07-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-07-12', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months', 'timeFrame': '12 months', 'description': 'Main outcome measures are the changes of retinal function of the macula monitored by multifocal-ERG as measured 12 months'}], 'secondaryOutcomes': [{'measure': 'to document changes in best corrected visual acuity measured on 4 meters', 'timeFrame': '12 months', 'description': 'to document changes in best corrected visual acuity measured on 4 meters'}, {'measure': 'to document changes in microperimetry', 'timeFrame': '12 months', 'description': 'to document changes in microperimetry'}, {'measure': 'to document changes in optical coherence tomography (OCT)', 'timeFrame': '12 months', 'description': 'to document changes in optical coherence tomography (OCT)'}]}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.uksh.de/Augenklinik_Lübeck/index.html', 'label': 'Link Text: University of Lübeck - Department of Ophthalmology - Germany'}]}, 'descriptionModule': {'briefSummary': 'In this prospective, open-label clinical study is to investigate the behavior of the retinal functions during development of diabetic macular disease (DME) under the influence of Lucentis. Measurements with the multifocal electroretinogram (ERG) and microperimetry is used here as an objective criteria to information about the retinal function obtain.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. diabetic macular edema with center involvement in at least one eye\n2. patients with a central retinal thickness\n3. patients with a BCVA of 78-24 EDTRS letters\n4. decrease in vision is due to DME and not due to other causes, in the opinion of the investigator\n5. Type 1 or type 2 diabetes mellitus diagnosed 2 years prior to screening\n\nExclusion Criteria:\n\n1. history or evidence of severe cardiac disease\n2. clinical or medical history uncontrolled hypertension or diabetes\n3. of unstable angina, acute coronary syndrome, myocardial infarction or revascularization with 6 months\n4. ventricular tachyarrhythmias requiring ongoing treatment\n5. history or evidence clinically significant peripheral vascular disease, such a intermittent claudication or prior amputation\n6. clinically significant impaired renal or hepatic function'}, 'identificationModule': {'nctId': 'NCT01638858', 'briefTitle': 'Treatment of Diabetic Macular Edema With 0.5mg Intraocular Ranibizumab (Lucentis)', 'organization': {'class': 'OTHER', 'fullName': 'University of Luebeck'}, 'officialTitle': 'A Prospective, Non-randomized, Mono-center, Cohort Study of Evaluate the Effects of 0.5mg Intraocular Ranibizumab (Lucentis)Injections on Retinal Function in Patients With Diabetic Macular Edema (DME) During Twelve Months', 'orgStudyIdInfo': {'id': 'Lucentis_DME_ERG'}, 'secondaryIdInfos': [{'id': '2011-002202-70', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Lucentis (Ranibizumab)', 'interventionNames': ['Drug: Lucentis (Ranibizumab)']}], 'interventions': [{'name': 'Lucentis (Ranibizumab)', 'type': 'DRUG', 'description': 'Ranibizumab Short- and Log-term Effects on Retinal Function measured by Multifocal-ERG and Microperimetry', 'armGroupLabels': ['Lucentis (Ranibizumab)']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lübeck', 'country': 'Germany', 'facility': 'University of Luebeck - Department of Ophthalmology', 'geoPoint': {'lat': 53.86893, 'lon': 10.68729}}], 'overallOfficials': [{'name': 'Salvatore Grisanti, M.D. Prof.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Luebeck - Department of Ophthalmology: Germany'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Luebeck', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Matthias Lueke', 'investigatorAffiliation': 'University of Luebeck'}}}}