Ignite Creation Date:
2025-12-24 @ 10:52 PM
Ignite Modification Date:
2025-12-25 @ 8:21 PM
Study NCT ID:
NCT01297569
Status:
COMPLETED
Last Update Posted:
2017-02-23
First Post:
2011-02-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ranibizumab "Treat and Extend" in Diabetic Macular Edma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System 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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-20', 'studyFirstSubmitDate': '2011-02-15', 'studyFirstSubmitQcDate': '2011-02-15', 'lastUpdatePostDateStruct': {'date': '2017-02-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-02-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2012-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Best Corrected Visual Acuity(BCVA)', 'timeFrame': 'from month 0 (baseline) to month 12'}], 'secondaryOutcomes': [{'measure': 'change in central retinal thickness (CRT)', 'timeFrame': 'from month 0 to month 12'}, {'measure': 'the number of injections needed', 'timeFrame': '12 months'}, {'measure': 'the number of patients with improvement in BCVA from baseline', 'timeFrame': '12 months'}, {'measure': 'the number of patients with > 5, 10 and 15 letters improvement from baseline, the latter including patients reaching BCVA >84', 'timeFrame': '12 months'}]}, 'conditionsModule': {'keywords': ['Diabetic macular edema', 'Macular edema', 'DME', 'Diabetic retinopathy', 'Diabetic eye disease', 'anti-VEGF', 'ranibizumab', 'Lucentis'], 'conditions': ['Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'This study is designed to explore a more individualized treatment regime based on achievement of disease stability to define a personal optimal treatment interval with ranibizumab in patients with visual impairment due to diabetic macular edema.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '18 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Visual impairment due to focal or diffuse macular edema with center involvement\n* Diabetes type 1 or 2, HbA1c \\< 12.0%\n* CRT = or \\> 250 μm\n\nExclusion Criteria:\n\n* Active inflammation or infection\n* Uncontrolled glaucoma\n* Iris neovascularization, active proliferative retinopathy or vitreomacular traction\n* Prior laser photocoagulation according to defined timelines\n* History of stroke, uncontrolled hypertension\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01297569', 'acronym': 'OPTIMAL', 'briefTitle': 'Ranibizumab "Treat and Extend" in Diabetic Macular Edma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'An Open-label, Prospective, Multicentre, Uncontrolled, Proof of Concept Study Assessing the Efficacy of Lucentis (Ranibizumab) Administered by an Individualized "Treat and Extend" Dosing Regimen in Patients With Visual Impairment Due to Diabetic Macular Edema', 'orgStudyIdInfo': {'id': 'CRFB002DNO02'}, 'secondaryIdInfos': [{'id': '2010-021182-76', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab', 'interventionNames': ['Drug: Ranibizumab']}], 'interventions': [{'name': 'Ranibizumab', 'type': 'DRUG', 'armGroupLabels': ['Ranibizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '0264', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}