Ignite Creation Date:
2025-12-24 @ 7:16 PM
Ignite Modification Date:
2025-12-25 @ 4:53 PM
Study NCT ID:
NCT00417703
Status:
COMPLETED
Last Update Posted:
2008-01-24
First Post:
2007-01-03
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 75}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2008-01', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-01-22', 'studyFirstSubmitDate': '2007-01-03', 'studyFirstSubmitQcDate': '2007-01-03', 'lastUpdatePostDateStruct': {'date': '2008-01-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-01-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'conditionsModule': {'keywords': ['Intraocular Pressure', 'Intravitreous Injection', 'Ranibizumab'], 'conditions': ['Choroidal Neovascularization']}, 'descriptionModule': {'briefSummary': 'This study will quantify the intraocular pressure elevation in the immediate time period following intravitreous injection. With more widespread use of intravitreous injections in patients that may require several injections per year, it is important to document the sudden increase in intraocular pressure, including the maximum intraocular pressure and the time required for the intraocular pressure to return to baseline. This data may be useful in stimulating additional studies to evaluate the long term ocular effects of repeated intravitreous injections.\n\nWe hypothesize that the intraocular pressure increases significantly following intravitreous injection and then returns to baseline during the initial thirty minutes following ranibizumab injection.', 'detailedDescription': 'We will assess the trend of intraocular pressure immediately following intravitreal injection of ranibizumab 0.5 mg (0.05 mL) by taking serial intraocular pressure readings every five minutes for thirty minutes after injection. This study is a prospective descriptive data collection consisting of measuring intraocular pressure immediately following intraocular injection, and at 5, 10, 15, 20, 25, and 30 minutes following injection of ranibizumab 0.5 mg.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Male or Female Patients \\>18 years of age\n2. Patients will have documented choroidal neovascular membranes on fluorescein angiogram and/or optical coherence tomography\n3. Requiring treatment or maintenance therapy for choroidal neovascular membrane\n4. Able and willing to provide written informed consent\n\nExclusion Criteria:\n\n1. History of arterial occlusive disease of the eye.\n2. History of advanced glaucoma.'}, 'identificationModule': {'nctId': 'NCT00417703', 'briefTitle': 'Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab', 'organization': {'class': 'OTHER', 'fullName': 'Oklahoma State University Center for Health Sciences'}, 'officialTitle': 'A Prospective Investigation of the Intraocular Pressure Immediately Following Intravitreous Injection of Ranibizumab', 'orgStudyIdInfo': {'id': '2006032'}}, 'contactsLocationsModule': {'locations': [{'zip': '74127', 'city': 'Tulsa', 'state': 'Oklahoma', 'country': 'United States', 'facility': 'Retina Support Services, Inc', 'geoPoint': {'lat': 36.15398, 'lon': -95.99277}}], 'overallOfficials': [{'name': 'Scott J Westhouse, DO', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Oklahoma State University Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Oklahoma State University Center for Health Sciences', 'class': 'OTHER'}}}}