Ignite Creation Date:
2025-12-25 @ 2:37 AM
Ignite Modification Date:
2026-03-06 @ 6:38 PM
Study NCT ID:
NCT00619034
Status:
COMPLETED
Last Update Posted:
2010-12-29
First Post:
2008-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmacological Intervention in Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2011-08-02', 'releaseDate': '2011-07-07'}, {'resetDate': '2011-09-19', 'releaseDate': '2011-08-15'}, {'resetDate': '2011-11-02', 'releaseDate': '2011-09-29'}, {'resetDate': '2012-02-21', 'releaseDate': '2012-01-20'}, {'resetDate': '2012-08-31', 'releaseDate': '2012-08-03'}, {'resetDate': '2012-11-23', 'releaseDate': '2012-10-25'}, {'resetDate': '2013-02-12', 'releaseDate': '2013-01-11'}, {'resetDate': '2024-05-03', 'releaseDate': '2023-11-30'}], 'estimatedResultsFirstSubmitDate': '2011-07-07'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'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': 'D000077338', 'term': 'Latanoprost'}, {'id': 'D004008', 'term': 'Diclofenac'}, {'id': 'C062765', 'term': 'dorzolamide'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D011461', 'term': 'Prostaglandins F, Synthetic'}, {'id': 'D011465', 'term': 'Prostaglandins, Synthetic'}, {'id': 'D011453', 'term': 'Prostaglandins'}, {'id': 'D015777', 'term': 'Eicosanoids'}, {'id': 'D005231', 'term': 'Fatty Acids, Unsaturated'}, {'id': 'D005227', 'term': 'Fatty Acids'}, {'id': 'D008055', 'term': 'Lipids'}, {'id': 'D012898', 'term': 'Autacoids'}, {'id': 'D018836', 'term': 'Inflammation Mediators'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'id': 'D010648', 'term': 'Phenylacetates'}, {'id': 'D000146', 'term': 'Acids, Carbocyclic'}, {'id': 'D002264', 'term': 'Carboxylic Acids'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D019999', 'term': 'Pharmaceutical Solutions'}, {'id': 'D012996', 'term': 'Solutions'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}, {'id': 'D045506', 'term': 'Therapeutic Uses'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}, {'id': 'D020313', 'term': 'Specialty Uses of Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['INVESTIGATOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-12', 'completionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-12-28', 'studyFirstSubmitDate': '2008-02-07', 'studyFirstSubmitQcDate': '2008-02-19', 'lastUpdatePostDateStruct': {'date': '2010-12-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Diameter of retinal blood vessels', 'timeFrame': 'one year'}], 'secondaryOutcomes': [{'measure': 'Influence on retinal blood flow in diabetes', 'timeFrame': 'one year'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine if diabetic retinopathy can be treated with prostaglandin analogues, prostaglandin synthesis inhibitors or carbonic anhydrases inhibitors.', 'detailedDescription': 'Disturbances in retinal perfusion is believed to be involved in the pathophysiology of diabetic retinopathy. These disturbances may be due to changes in the basal diameter of retinal arterioles and to disturbances in the autoregulation of the diameter of these vessels when the blood pressure and the retinal metabolism changes. In vitro studies have shown that prostaglandins and carbonic anhydrases inhibitors are involved in the tone regulation of retinal arterioles, but it is unknown whether this finding is relevant in clinical practice. This can be tested in vivo by an retinal vessel analyzer measuring the dynamics of the retinal vessel diameter changes.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diabetes type 1 with moderate diabetic retinopathy/healthy\n* Blood pressure \\< 135/85 mmHg\n\nExclusion Criteria:\n\n* Eye disease (excluding diabetic retinopathy)\n* Allergic\n* Kidney disease\n* Liver disease\n* Severe asthma\n* Heart disease\n* Hypertension arterial\n* Users of drugs that influence the metabolism of the prostaglandins in the carbon dioxide\n* Pregnant and breastfeeding women and women who don't use secure contraception\n* Persons who can't do without contact lens in the treated eye."}, 'identificationModule': {'nctId': 'NCT00619034', 'acronym': 'XAVOT', 'briefTitle': 'Pharmacological Intervention in Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Aarhus'}, 'officialTitle': 'Pharmacological Intervention Against Diabetic Retinal Flow Disturbances.', 'orgStudyIdInfo': {'id': '2007-001697-84'}, 'secondaryIdInfos': [{'id': 'XAVOT'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'latanoprost', 'description': 'Medical intervention cross-over', 'interventionNames': ['Drug: Latanoprost, diclofenac and dorzolamide (eyedrops)']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'diclofenac', 'description': 'medical intervention', 'interventionNames': ['Drug: Diclofenac']}, {'type': 'EXPERIMENTAL', 'label': 'dorzolamide', 'description': 'dorzolamide eyedrops twice daily in one week', 'interventionNames': ['Drug: Dorzolamide']}], 'interventions': [{'name': 'Latanoprost, diclofenac and dorzolamide (eyedrops)', 'type': 'DRUG', 'otherNames': ['Xalatan', 'Voltaren ophtha', 'Trusopt'], 'description': '1 eyedrop twice daily in one week', 'armGroupLabels': ['latanoprost']}, {'name': 'Diclofenac', 'type': 'DRUG', 'otherNames': ['Voltaren ophtha'], 'description': 'dicolfenac eyedrops twice daily i one eye', 'armGroupLabels': ['diclofenac']}, {'name': 'Dorzolamide', 'type': 'DRUG', 'otherNames': ['Trusopt eyedrops'], 'description': 'dorzolamide eyedrops twice daily, in one eye for one week', 'armGroupLabels': ['dorzolamide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8000', 'city': 'Aarhus', 'country': 'Denmark', 'facility': 'Department of Ophthalmology', 'geoPoint': {'lat': 56.15674, 'lon': 10.21076}}], 'overallOfficials': [{'name': 'Kathrine K Tilma, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology - Aarhus, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Aarhus', 'class': 'OTHER'}, 'responsibleParty': {'oldNameTitle': 'Øjenafd. J', 'oldOrganization': 'Department of Ophthalmology'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2011-07-07', 'type': 'RELEASE'}, {'date': '2011-08-02', 'type': 'RESET'}, {'date': '2011-08-15', 'type': 'RELEASE'}, {'date': '2011-09-19', 'type': 'RESET'}, {'date': '2011-09-29', 'type': 'RELEASE'}, {'date': '2011-11-02', 'type': 'RESET'}, {'date': '2012-01-20', 'type': 'RELEASE'}, {'date': '2012-02-21', 'type': 'RESET'}, {'date': '2012-08-03', 'type': 'RELEASE'}, {'date': '2012-08-31', 'type': 'RESET'}, {'date': '2012-10-25', 'type': 'RELEASE'}, {'date': '2012-11-23', 'type': 'RESET'}, {'date': '2013-01-11', 'type': 'RELEASE'}, {'date': '2013-02-12', 'type': 'RESET'}, {'date': '2023-11-30', 'type': 'RELEASE'}, {'date': '2024-05-03', 'type': 'RESET'}], 'unpostedResponsibleParty': 'University of Aarhus'}}}}