Ignite Creation Date:
2025-12-24 @ 3:22 PM
Ignite Modification Date:
2025-12-28 @ 8:21 AM
Study NCT ID:
NCT01945892
Status:
COMPLETED
Last Update Posted:
2013-09-19
First Post:
2013-09-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dexamethasone-Implant for the Treatment of Macula Edema Due to Irvine Gass Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D002123', 'term': 'Calcium Dobesilate'}], 'ancestors': [{'id': 'D001557', 'term': 'Benzenesulfonates'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D001190', 'term': 'Arylsulfonates'}, {'id': 'D017739', 'term': 'Arylsulfonic Acids'}, {'id': 'D013451', 'term': 'Sulfonic Acids'}, {'id': 'D013456', 'term': 'Sulfur Acids'}, {'id': 'D013457', 'term': 'Sulfur Compounds'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-09', 'completionDateStruct': {'date': '2013-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2013-09-18', 'studyFirstSubmitDate': '2013-09-16', 'studyFirstSubmitQcDate': '2013-09-18', 'lastUpdatePostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-09-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': '12 months', 'description': 'Best corrected visual acuity and visual acuity gain after 6 and 12 months.'}], 'secondaryOutcomes': [{'measure': 'Retinal Thickness', 'timeFrame': '12 months', 'description': 'Retinal thickness measured by OCT.'}, {'measure': 'Intraocular pressure', 'timeFrame': '12 months', 'description': 'Intraocular pressure using Goldmann applanation tonometer'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['macular edema, irvine gass syndrome, ozurdex'], 'conditions': ['Macular Edema', 'Visual Acuity']}, 'descriptionModule': {'briefSummary': 'To analyze macula edema formation after cataract surgery called Irvine-Gass-Syndrome.', 'detailedDescription': '20 to 25 patients suffering from Irvine Gass Syndrom should be monitored for at least six months, controlled monthly. In all cases best corrected visual acuity, Spectralis-OCT (volume thickness scan), fundus photography (Optomap), intraocular pressure, slitlamp assessment and indirect ophthalmoscopy should be performed on every visit. Fluorescein angiography should be performed at baseline and after 3 and 6 months.\n\nInclusion criteria:\n\nPatients older than 18 years who develop macula edema secondary to cataract surgery.\n\n\\- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".\n\nExclusion criteria:\n\nVisual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.\n\nOutcome:\n\n* BCVA\n* Patients suffering from diabetes mellitus should be evaluated also separately.\n* Change in central retinal thickness using optical coherence tomography (OCT)\n* Secondary parameters (elevated IOP, retinal detachments, vitreous hemorrhage, endophthalmitis rates)'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients older than 18 years.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nPatients older than 18 years who develop macula edema secondary to cataract surgery\n\nExclusion Criteria:\n\nVisual acuity worse than 20/400, known history of glaucoma and steroid response, any macular disease interfering with visual acuity (DME, AMD, etc.), history of vitrectomy, use of systemic, periocular, or intraocular corticosteroids within 30 days.'}, 'identificationModule': {'nctId': 'NCT01945892', 'briefTitle': 'Dexamethasone-Implant for the Treatment of Macula Edema Due to Irvine Gass Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig-Maximilians - University of Munich'}, 'officialTitle': 'Ozurdex as an Treatment Option for Macula Edema Due to Irvine Gass Syndrome', 'orgStudyIdInfo': {'id': 'MAF/ISS/OPH/RET/011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Irvine Gass Syndrome', 'description': 'Patients older than 18 years who develop macula edema secondary to cataract surgery.\n\nGroup may receive intravitreal Ozurdex medication in case of persistent macular edema.', 'interventionNames': ['Drug: Ozurdex']}], 'interventions': [{'name': 'Ozurdex', 'type': 'DRUG', 'otherNames': ['Dexamethasone-implant'], 'description': '\\- Consent agreement - Patients should be informed that it is possible to get an active medication (Ozurdex implant) as an "on label" indication from the health insurance company if the diagnosis is accepted as an intraocular inflammation form of "Uveitis posterior".', 'armGroupLabels': ['Irvine Gass Syndrome']}]}, 'contactsLocationsModule': {'locations': [{'zip': '80336', 'city': 'Munich', 'country': 'Germany', 'facility': 'Dept. of Ophthalmology, LMU Munich', 'geoPoint': {'lat': 48.13743, 'lon': 11.57549}}], 'overallOfficials': [{'name': 'Wolfgang J Mayer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LMU Munich'}, {'name': 'Christos Haritoglou, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'LMU Munich'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig-Maximilians - University of Munich', 'class': 'OTHER'}, 'collaborators': [{'name': 'Allergan', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Wolfgang Mayer', 'investigatorAffiliation': 'Ludwig-Maximilians - University of Munich'}}}}