Ignite Creation Date:
2025-12-24 @ 3:25 PM
Ignite Modification Date:
2026-02-20 @ 1:44 PM
Study NCT ID:
NCT01753492
Status:
TERMINATED
Last Update Posted:
2015-05-25
First Post:
2012-12-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Trabeculectomy With Ologen
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 7}}, 'statusModule': {'whyStopped': 'The results were disappointing.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2015-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-22', 'studyFirstSubmitDate': '2012-12-12', 'studyFirstSubmitQcDate': '2012-12-19', 'lastUpdatePostDateStruct': {'date': '2015-05-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'bleb aspect: hyperemia (grade 1, 2 or 3), bleb height (1, 2 or 3)', 'timeFrame': '3 months'}, {'measure': 'surgery time', 'timeFrame': '3 months'}, {'measure': 'complexity of surgical procedure', 'timeFrame': '3 months'}, {'measure': 'number of patients withdrawn from study because of failure', 'timeFrame': '3 months'}], 'primaryOutcomes': [{'measure': 'Postoperative intraocular pressure level', 'timeFrame': '3 months'}], 'secondaryOutcomes': [{'measure': 'Number of glaucoma medications', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Intraocular pressure', 'glaucoma', 'trabeculectomy', 'Ologen'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': 'Trabeculectomy is the gold standard procedure for the surgical treatment of glaucoma. Antimetabolites such as mitomycin-C (MMC)are widely used as an adjunctive during surgery to prevent scarring of the bleb. MMC has the risk for creating thin bleb walls, avascular blebs, and increased risk to infection, blebitis and endophthalmitis.\n\nRecently, a biodegradable porous collagen-glycosaminoglycan copolymer matrix implant (Ologen), has become available for glaucoma surgery.Although a few studies on filtering surgery with Ologen implantation have been performed, there is yet no conclusive evidence on effectivity and safety with Ologen implantation when compared to trabeculectomy with MMC.\n\nThis is a prospective intervention pilot study to determine the degree of intraocular pressure (IOP) lowering of trabeculectomy with Ologen implantation in comparison to trabeculectomy with MMC. Additionally, the safety (per- and postoperative complications) of the two procedures will be compared.\n\nThe study hypothesis is that trabeculectomy with Ologen will be a safer procedure than trabeculectomy with MMC, but probably at the cost of a less potent IOP lowering.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Primary open-angle glaucoma with progression of visual field loss and/or uncontrolled intraocular pressure levels with medication.\n* Indication for trabeculectomy with mitomycin-C\n\nExclusion Criteria:\n\n* Unability to discontinue oral anticoagulants\n* Difficulty in reading or speaking Dutch\n* Previous ocular surgery (cataract surgery allowed)\n* Pregnant and breastfeeding women'}, 'identificationModule': {'nctId': 'NCT01753492', 'briefTitle': 'Trabeculectomy With Ologen', 'organization': {'class': 'OTHER', 'fullName': 'Maastricht University Medical Center'}, 'officialTitle': 'Trabeculectomy With Ologen-Pilot', 'orgStudyIdInfo': {'id': 'NL42312.068.12/METC12-2-073'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ologen implantation (single arm)', 'description': 'Ologen implantation as an adjunctive to trabeculectomy', 'interventionNames': ['Device: Ologen']}], 'interventions': [{'name': 'Ologen', 'type': 'DEVICE', 'armGroupLabels': ['Ologen implantation (single arm)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6202 AZ', 'city': 'Maastricht', 'country': 'Netherlands', 'facility': 'University Eye Clinic', 'geoPoint': {'lat': 50.84833, 'lon': 5.68889}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'Aeon Astron Europe B.V.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD, Ophthalmologist', 'investigatorFullName': 'Henny Beckers', 'investigatorAffiliation': 'Maastricht University Medical Center'}}}}