Ignite Creation Date:
2025-12-25 @ 4:23 AM
Ignite Modification Date:
2025-12-26 @ 3:25 AM
Study NCT ID:
NCT00371020
Status:
UNKNOWN
Last Update Posted:
2007-07-12
First Post:
2006-08-31
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D018630', 'term': 'Vitreoretinopathy, Proliferative'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D006495', 'term': 'Heparin, Low-Molecular-Weight'}, {'id': 'D005472', 'term': 'Fluorouracil'}], 'ancestors': [{'id': 'D006493', 'term': 'Heparin'}, {'id': 'D006025', 'term': 'Glycosaminoglycans'}, {'id': 'D011134', 'term': 'Polysaccharides'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D014498', 'term': 'Uracil'}, {'id': 'D011744', 'term': 'Pyrimidinones'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2005-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2007-07', 'completionDateStruct': {'date': '2007-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2007-07-11', 'studyFirstSubmitDate': '2006-08-31', 'studyFirstSubmitQcDate': '2006-08-31', 'lastUpdatePostDateStruct': {'date': '2007-07-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2006-09-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Retinal redetachment rate'}], 'secondaryOutcomes': [{'measure': 'visual acuity'}, {'measure': 'intraocular pressure'}, {'measure': 'reoperation'}, {'measure': 'relative afferent pupillary defect'}]}, 'conditionsModule': {'keywords': ['silicone oil', 'PVR', 'retinal redetachment', 'low molecular weight heparin', '5-FU'], 'conditions': ['Proliferative Vitreoretinopathy']}, 'descriptionModule': {'briefSummary': 'To evaluate the effect of combined 5-FU and low molecular weight heparin in infusion on the rate of retinal redetachment after silicone oil removal in cases of proliferative vitreoretinopathy (PVR).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Cases with history of vitrectomy and silicone oil injection for management of PVR who undergo silicone oil removal\n\nExclusion Criteria:\n\n* any sign of retinal redetachment before silicone oil removal\n* any sign of diabetic retinopathy'}, 'identificationModule': {'nctId': 'NCT00371020', 'briefTitle': 'The Effect of 5-FU and LMW Heparin on the Rate of Retinal Redetachment After Silicone Oil Removal in Cases of PVR', 'organization': {'class': 'OTHER', 'fullName': 'Shahid Beheshti University of Medical Sciences'}, 'orgStudyIdInfo': {'id': '8373'}}, 'armsInterventionsModule': {'interventions': [{'name': 'low molecular weight heparin, 5-FU', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '16666', 'city': 'Tehran', 'state': 'Tehran Province', 'country': 'Iran', 'facility': 'Hamid Ahmadieh, MD', 'geoPoint': {'lat': 35.69439, 'lon': 51.42151}}], 'overallOfficials': [{'name': 'Hamid Ahmadieh, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ophthalmic Research Center of Shaheed Beheshti Medical University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shahid Beheshti University of Medical Sciences', 'class': 'OTHER'}}}}