Ignite Creation Date:
2025-12-24 @ 5:22 PM
Ignite Modification Date:
2025-12-28 @ 11:23 PM
Study NCT ID:
NCT02140450
Status:
COMPLETED
Last Update Posted:
2014-05-16
First Post:
2014-05-09
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D013999', 'term': 'Timolol'}, {'id': 'D000068438', 'term': 'Brimonidine Tartrate'}, {'id': 'D000086', 'term': 'Acetazolamide'}, {'id': 'D008353', 'term': 'Mannitol'}, {'id': 'C005703', 'term': 'salicylhydroxamic acid'}], 'ancestors': [{'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': 'D013830', 'term': 'Thiadiazoles'}, {'id': 'D013844', 'term': 'Thiazoles'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}, {'id': 'D001393', 'term': 'Azoles'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009025', 'term': 'Morpholines'}, {'id': 'D010078', 'term': 'Oxazines'}, {'id': 'D011810', 'term': 'Quinoxalines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D013402', 'term': 'Sugar Alcohols'}, {'id': 'D002241', 'term': 'Carbohydrates'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 70}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-05', 'completionDateStruct': {'date': '2014-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-05-13', 'studyFirstSubmitDate': '2014-05-09', 'studyFirstSubmitQcDate': '2014-05-13', 'lastUpdatePostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2014-05-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in IOP', 'timeFrame': '0, 5, 10, 15, 30 minutes after injection', 'description': 'the change in intraocular pressure after intravitreal injection of bevacizumab'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['intraocular pressure, intravitreal injection, short term'], 'conditions': ['Intraocular Pressure Change in Intravitreal Injection']}, 'referencesModule': {'references': [{'pmid': '33389369', 'type': 'DERIVED', 'citation': 'Shoeibi N, Ghosi Z, Jafari H, Omidtabrizi A. Effect of antiglaucoma agents on short-term intraocular pressure fluctuations after intravitreal bevacizumab injections. Int Ophthalmol. 2021 Mar;41(3):1081-1090. doi: 10.1007/s10792-020-01667-z. Epub 2021 Jan 2.'}]}, 'descriptionModule': {'briefSummary': 'To assess the effect of prophylactic antiglaucoma agents in prevention of acute intraocular pressure rise after intravitreal injection.', 'detailedDescription': 'Acute intraocular pressure elevation after intravitreal injection of bevacizumab was proven.Acute intraocular pressure elevation most probably is volume related and long term intraocular pressure elevation relates to pharmacologic features of the medications which results in anatomic changes in the angle of anterior chamber.Numerous studies found an intraocular pressure elevation right after the injection and quick normalization within maximally 30 minutes.This intraocular pressure elevation which lasts about 30 minutes, can result in irreversible visual loss especially in patients with critical remaining nerve fibers in the optic nerve head, as occurs in glaucomatous patients. Is there any way to prevent or even shorten this time of intraocular pressure elevation? We tried in our study to find a suitable response for a question above, so we used several anti-glaucoma agents (Timolol, Brimonidine, Acetazolamide, Mannitol versus placebo) as a prophylaxis to prevent acute intraocular pressure elevation right after intravitreal bevacizumab injection.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '40 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* all patients who candidate for receiving intravitreal bevacizumab\n\nExclusion Criteria:\n\n* patients who had advanced glaucoma\n* patients who received antiglaucoma agents in the past\n* patients who had corneal scar which affect IOP measurement'}, 'identificationModule': {'nctId': 'NCT02140450', 'briefTitle': 'Effect of Antiglaucoma Agents on Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection', 'organization': {'class': 'OTHER', 'fullName': 'Mashhad University of Medical Sciences'}, 'officialTitle': 'Short Term Intraocular Pressure Fluctuations After Intravitreal Bevacizumab Injection: the Effect of Pretreatment With Antiglaucoma Agents', 'orgStudyIdInfo': {'id': '910292'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Timolol', 'description': 'Timolol eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection', 'interventionNames': ['Drug: Timolol']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Brimonidine', 'description': 'Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection', 'interventionNames': ['Drug: Brimonidine']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Acetazolamide', 'description': 'Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection', 'interventionNames': ['Drug: Acetazolamide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Mannitol', 'description': 'Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection', 'interventionNames': ['Drug: Mannitol']}, {'type': 'SHAM_COMPARATOR', 'label': 'Placebo', 'description': 'Artificial tears, 2 drops, 1-2 hours before intravitreal injection', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'Timolol', 'type': 'DRUG', 'otherNames': ['Timoptic'], 'description': '2 drops of timolol, 10 minutes apart, 1-2 hours before intravitreal injection', 'armGroupLabels': ['Timolol']}, {'name': 'Brimonidine', 'type': 'DRUG', 'otherNames': ['Alphagan'], 'description': 'Brimonidine eyedrop, 2 drops 5 minutes apart, 1-2 hours before intravitreal injection', 'armGroupLabels': ['Brimonidine']}, {'name': 'Acetazolamide', 'type': 'DRUG', 'otherNames': ['Diamox'], 'description': 'Acetazolamide tablet, 2 tabs, 2 hours before intravitreal injection', 'armGroupLabels': ['Acetazolamide']}, {'name': 'Mannitol', 'type': 'DRUG', 'description': 'Intravenous mannitol, 1.5 gram/kg, 1 hour before intravitreal injection', 'armGroupLabels': ['Mannitol']}, {'name': 'Placebo', 'type': 'DRUG', 'otherNames': ['Sham'], 'description': 'Artificial tears, 2 drops, 1-2 hours before intravitreal injection', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Mashhad', 'state': 'Khorasan Razavi', 'country': 'Iran', 'facility': 'Retina Research Center, Khatam eye Hospital', 'geoPoint': {'lat': 36.29807, 'lon': 59.60567}}], 'overallOfficials': [{'name': 'Nasser Shoeibi, M.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Retina Research Center, Mashhad University of Medical Sciences, Mashhad, Iran'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mashhad University of Medical Sciences', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of Ophthalmology', 'investigatorFullName': 'Nasser Shoeibi', 'investigatorAffiliation': 'Mashhad University of Medical Sciences'}}}}