Ignite Creation Date:
2025-12-24 @ 1:43 PM
Ignite Modification Date:
2025-12-27 @ 10:38 PM
Study NCT ID:
NCT01535495
Status:
COMPLETED
Last Update Posted:
2017-03-31
First Post:
2012-02-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Propranolol for Diabetic Retinopathy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}], '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': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011433', 'term': 'Propranolol'}], 'ancestors': [{'id': 'D050198', 'term': 'Phenoxypropanolamines'}, {'id': 'D011412', 'term': 'Propanolamines'}, {'id': 'D000605', 'term': 'Amino Alcohols'}, {'id': 'D000438', 'term': 'Alcohols'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D020005', 'term': 'Propanols'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009281', 'term': 'Naphthalenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-29', 'studyFirstSubmitDate': '2012-02-14', 'studyFirstSubmitQcDate': '2012-02-14', 'lastUpdatePostDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-02-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Area of retinal neovascularization on fundus photography', 'timeFrame': '12 weeks'}], 'secondaryOutcomes': [{'measure': 'Retinopathy level in contralateral eye', 'timeFrame': '12 weeks'}, {'measure': 'Optical coherence tomography macular thickness of treated and fellow eye', 'timeFrame': '12 weeks'}, {'measure': 'Amount of fluorescein leakage on angiography', 'timeFrame': '12 weeks'}, {'measure': 'Early Treatment Diabetic Retinopathy Study visual acuity in study and fellow eye', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['beta-antagonist', 'propranolol', 'diabetic retinopathy', 'diabetes', 'angiogenesis', 'neovascularization'], 'conditions': ['Proliferative Diabetic Retinopathy']}, 'descriptionModule': {'briefSummary': 'This study is investigating if the oral beta antagonist propranolol can induce regression of retinal neovascularization associated with proliferative diabetic retinopathy.', 'detailedDescription': 'Oral propranolol 120mg daily will be given to 10 patients with proliferative diabetic retinopathy over a 12 week period to evaluate the effect on retinal neovascularization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age \\>=18 years\n* Eyes with proliferative diabetic retinopathy and neovascularization\n* Eyes with a history of panretinal photocoagulation treatment and persistent neovascularization deemed by the investigator to be a potential threat to visual acuity either by causing a vitreous hemorrhage or tractional retinal detachment. (Group 1 - maximum 5 eyes enrolled with these characteristics)\n* Eyes without a history of panretinal photocoagulation treatment, but that do not have high-risk proliferative diabetic retinopathy characteristics (i.e. these are eyes that have early proliferative diabetic retinopathy that are not yet at a high-risk for vitreous hemorrhage and tractional retinal detachment such that panretinal photocoagulation laser may be deferred). (Group 2 - maximum 5 eyes enrolled with these characteristics)\n\nExclusion Criteria:\n\n* Either panretinal photocoagulation laser or focal/grid laser into study eye within 3 months of study enrollment\n* Anti-Vascular endothelial growth factor injection into study eye within 3 months of study enrollment\n* Contraindications to beta-blockers such as: allergy, previous intolerance, abnormally slow heart rates, asthma or chronic obstructive pulmonary disease, use of medications that have an effect on certain drug metabolic pathways that may cause interactions.\n* Known coronary arterial disease or left ventricular dysfunction, or known peripheral vascular disease\n* Resting heart rate \\<60 or systolic blood pressure \\<90 and/or diastolic blood pressure \\<50\n* Pregnancy\n* All patients will either be post-menopausal, have adequate birth control and, if of childbearing age, will have a urinary pregnancy test performed\n* Allergy to fluorescein dye\n* Media opacity obscuring adequate determination of neovascularization including dense cataract or dense vitreous hemorrhage\n* Patient is already taking an oral beta-blocker\n* Vulnerable populations such as prisoners and minors will also be excluded'}, 'identificationModule': {'nctId': 'NCT01535495', 'briefTitle': 'Propranolol for Diabetic Retinopathy', 'organization': {'class': 'OTHER', 'fullName': 'University of Wisconsin, Madison'}, 'officialTitle': 'Propranolol for Diabetic Retinopathy', 'orgStudyIdInfo': {'id': 'UW 2011-0475'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Complete laser', 'description': 'Patients who have had complete panretinal photocoagulation laser treatment and active retinal neovascularization', 'interventionNames': ['Drug: Propranolol']}, {'type': 'EXPERIMENTAL', 'label': 'Laser naive', 'description': 'Patients who have not had panretinal photocoagulation laser treatment and active retinal neovascularization without so called "high-risk" characteristics', 'interventionNames': ['Drug: Propranolol']}], 'interventions': [{'name': 'Propranolol', 'type': 'DRUG', 'otherNames': ['Both groups receive the same intervention'], 'description': 'Propranolol XL 120mg by mouth once daily', 'armGroupLabels': ['Complete laser', 'Laser naive']}]}, 'contactsLocationsModule': {'locations': [{'zip': '53705', 'city': 'Madison', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'University of Wisconsin - Madison', 'geoPoint': {'lat': 43.07305, 'lon': -89.40123}}], 'overallOfficials': [{'name': 'Michael S Ip, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'UW Madison'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Wisconsin, Madison', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}