Ignite Creation Date:
2025-12-24 @ 4:17 PM
Ignite Modification Date:
2026-03-08 @ 6:00 AM
Study NCT ID:
NCT00744666
Status:
UNKNOWN
Last Update Posted:
2009-08-06
First Post:
2008-08-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D011239', 'term': 'Prednisolone'}, {'id': 'D009883', 'term': 'Ophthalmic Solutions'}], 'ancestors': [{'id': 'D011246', 'term': 'Pregnadienetriols'}, {'id': 'D011245', 'term': 'Pregnadienes'}, {'id': 'D011278', 'term': 'Pregnanes'}, {'id': 'D013256', 'term': 'Steroids'}, {'id': 'D000072473', 'term': 'Fused-Ring Compounds'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}, {'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': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SCREENING', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 70}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2008-09'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2009-08', 'completionDateStruct': {'date': '2010-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2009-08-04', 'studyFirstSubmitDate': '2008-08-29', 'studyFirstSubmitQcDate': '2008-08-29', 'lastUpdatePostDateStruct': {'date': '2009-08-06', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-09-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To detect a 60% or greater decrease of developing ocular hypertension (>20 mmHg) in the group of patients who received a trial of prednisolone 1% gtts x 4 weeks, compared the group who did not receive a trial of topical prednisolone.', 'timeFrame': 'Monthly for 6 months'}], 'secondaryOutcomes': [{'measure': 'Visual Acuity', 'timeFrame': 'Monthly for 6 months'}, {'measure': 'Incidence of other complications (cataract, retinal detachment, endophthalmitis)', 'timeFrame': 'Monthly for 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intravitreal triamcinolone acetonide', 'Side-effects', 'Ocular hypertension', 'Glaucoma', 'Prevention', 'Vitreoretinal diseases requiring IVTA for treatment'], 'conditions': ['Vitreoretinal Disease', 'Ocular Hypertension']}, 'referencesModule': {'references': [{'pmid': '12488256', 'type': 'BACKGROUND', 'citation': 'Jonas JB, Kreissig I, Degenring R. Intraocular pressure after intravitreal injection of triamcinolone acetonide. Br J Ophthalmol. 2003 Jan;87(1):24-7. doi: 10.1136/bjo.87.1.24.'}]}, 'descriptionModule': {'briefSummary': 'Intravitreal triamcinolone acetonide (IVTA) is a commonly employed treatment for various vitreoretinal disorders. However, approximately 23% to 50% of patients who receive IVTA develop ocular hypertension after the drug is injected into the eye. Similar to IVTA, topically administered corticosteroids eye drops result in ocular hypertension in approximately 33% of the population. It is unknown whether identifying patients who develop ocular hypertension from topical corticosteroids could be used to identify patients who are at risk for injectable IVTA. Therefore, the purpose of this study is to evaluate the efficacy of topical prednisolone 1% four times daily for one month as a screening test to reduce the incidence and severity of ocular hypertension after IVTA injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients diagnosed with vitreoretinal disease for which IVTA has been chosen as treatment\n\nExclusion Criteria:\n\n* \\< 18 years old\n* Pregnancy\n* Breast feeding\n* hx of uveitis\n* hx of neovascularization of the iris or anterior chamber angle\n* hx of ocular herpes simplex keratitis\n* hx of glaucoma\n* Unable to provide informed consent'}, 'identificationModule': {'nctId': 'NCT00744666', 'acronym': 'IVTA:PRE-TREAT', 'briefTitle': 'IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids', 'organization': {'class': 'OTHER', 'fullName': 'Hotel Dieu Hospital'}, 'officialTitle': 'IntraVitreal Triamcinolone Acetonide: Preventing Raised Eye-pressure by Tracking Elevations After Topical Steroids', 'orgStudyIdInfo': {'id': '07142008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '1', 'description': 'Patients receive Prednisolone 1% 1gtt qid x 4 weeks. If the intraocular pressure (IOP) after the 4 weeks is \\> or equal to 21 mmHg, then IVTA will be withheld. If the IOP \\< 21mmHg, then patients will receive an injection of IVTA.', 'interventionNames': ['Drug: Prednisolone 1% topical eye drops']}, {'type': 'NO_INTERVENTION', 'label': '2', 'description': 'Patients will receive an injection of IVTA (no trial of Prednisolone gtts is given).'}], 'interventions': [{'name': 'Prednisolone 1% topical eye drops', 'type': 'DRUG', 'description': 'Prednisolone 1% 1gtt qid to the eye requiring IVTA', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'K7L 5G2', 'city': 'Kingston', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Jeffery Gale, MD, FRCSC', 'role': 'CONTACT', 'email': 'jeffgaleuwo@yahoo.com', 'phone': '613-544-3400', 'phoneExt': '3391'}, {'name': 'Christina Leung, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Jeffery Gale, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Delan Jinapriya, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Hotel Dieu Hospital', 'geoPoint': {'lat': 44.22976, 'lon': -76.48098}}, {'zip': 'K1H 8L6', 'city': 'Ottawa', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Bernard Hurley, MD, FRCSC', 'role': 'CONTACT', 'email': 'bhurley@Ottawahospital.on.ca', 'phone': '(613) 737-8899', 'phoneExt': '79422'}, {'name': 'Bernard Hurley, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Sylvia Chen, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'The Ottawa Hospital', 'geoPoint': {'lat': 45.41117, 'lon': -75.69812}}, {'zip': 'M4N3M5', 'city': 'Toronto', 'state': 'Ontario', 'status': 'RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Kenneth Eng, MD, FRCSC', 'role': 'CONTACT', 'email': 'kt_eng@hotmail.com', 'phone': '416-480-4688'}, {'name': 'Peter Kertes, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Carol Schwartz, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Daniel Weisbrod, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Kenneth Eng, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Sunnybrook Health Sciences Centre', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}, {'zip': 'M5T 2S8', 'city': 'Toronto', 'state': 'Ontario', 'status': 'NOT_YET_RECRUITING', 'country': 'Canada', 'contacts': [{'name': 'Brent Michael, MD, FRCSC', 'role': 'CONTACT', 'email': 'mh.brent@utoronto.ca', 'phone': '416-603-5444'}, {'name': 'Michael Brent, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Chirag Shah, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Patrick Santiago, MD, FRCSC', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Toronto Western Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'centralContacts': [{'name': 'Kenneth Eng, MD, FRCSC', 'role': 'CONTACT', 'email': 'kt_eng@hotmail.com', 'phone': '416-480-4468'}, {'name': 'Jeffery Gale, MD, FRCSC', 'role': 'CONTACT', 'email': 'jeffgaleuwo@yahoo.com', 'phone': '613-544-3400', 'phoneExt': '3391'}], 'overallOfficials': [{'name': 'Kenneth Eng, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sunnybrook Health Sciences Centre'}, {'name': 'Jeffery Gale, MD, FRCSC', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hotel Dieu Hospital'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hotel Dieu Hospital', 'class': 'OTHER'}, 'collaborators': [{'name': 'Sunnybrook Health Sciences Centre', 'class': 'OTHER'}], 'responsibleParty': {'oldNameTitle': 'Dr. Kenneth Eng', 'oldOrganization': 'Sunnybrook Health Sciences Centre'}}}}