Ignite Creation Date:
2025-12-25 @ 2:55 AM
Ignite Modification Date:
2026-06-26 @ 4:16 AM
Study NCT ID:
NCT02406833
Status:
COMPLETED
Last Update Posted:
2018-02-28
First Post:
2015-03-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phase I Dose Escalation Study to Investigate the Safety of ISTH0036 in Subjects With Glaucoma Undergoing Trabeculectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}, {'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000625771', 'term': 'ISTH0036'}, {'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-02', 'completionDateStruct': {'date': '2017-08', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-02-27', 'studyFirstSubmitDate': '2015-03-25', 'studyFirstSubmitQcDate': '2015-03-30', 'lastUpdatePostDateStruct': {'date': '2018-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-04-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety and tolerability as assessed by clinical monitoring and reporting of adverse events (AE) and serious adverse events (SAE)', 'timeFrame': '1 year'}], 'secondaryOutcomes': [{'measure': 'Intraocular pressure', 'timeFrame': '1 year'}, {'measure': 'Number of interventions post trabeculectomy', 'timeFrame': '1 year'}, {'measure': 'Visual field', 'timeFrame': '1 year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glaucoma', 'trabeculectomy'], 'conditions': ['Primary Open Angle Glaucoma']}, 'descriptionModule': {'briefSummary': 'This study evaluates the addition of ISTH0036, an antisense oligonucleotide against TGF-β2, to glaucoma filtration surgery (trabeculectomy). The treatment aims at improving the surgery outcome by prevention of excessive scarring and trabecular meshwork transformation.', 'detailedDescription': 'The transforming growth factor beta (TGF-β) is known to play a key role in glaucoma. Increased levels of TGF-β2 in the eye have been linked to trabecular meshwork transformation, increased intraocular pressure and direct optic nerve damage.\n\nTrabeculectomy is the standard surgical intervention to reduce intraocular pressure in subjects no longer sufficiently responding to pressure-lowering medications. Scarring of the surgically opened canal (bleb) often abolishes the effect of trabeculectomy (despite the intraoperative use of Mitomycin C to prevent this). TGF-β2 has been described to play a distinct role in the fibrotic process of bleb closure.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Subject scheduled for trabeculectomy with Mitomycin C\n* Subject no longer tolerating or benefitting from pharmacologic treatment of glaucoma\n\nExclusion Criteria:\n\n* History of relevant ocular trauma \\< 6 months or ocular infection/inflammation \\< 3 months\n* severe central visual field loss within 6 months unrelated to glaucoma\n* pregnant or nursing women or subjects not using adequate contraception\n* history or evidence of any other clinically significant disorder, condition or disease that would pose a risk to subject safety or interfere with study evaluations, procedures or interpretation'}, 'identificationModule': {'nctId': 'NCT02406833', 'briefTitle': 'Phase I Dose Escalation Study to Investigate the Safety of ISTH0036 in Subjects With Glaucoma Undergoing Trabeculectomy', 'organization': {'class': 'INDUSTRY', 'fullName': 'Isarna Therapeutics GmbH'}, 'officialTitle': "A Phase I, Open-Label, Dose-Escalation Study to Investigate the Safety of ISTH0036, a 'Next Generation' TGF-β2-Selective Antisense Oligonucleotide, in Subjects With Primary Open-Angle Glaucoma Undergoing Trabeculectomy", 'orgStudyIdInfo': {'id': 'ISTH-01-111'}, 'secondaryIdInfos': [{'id': '2014-004985-74', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'TGF-β2 antisense oligonucleotide', 'description': 'Core Study: Administered intravitreally at the time of trabeculectomy at escalating doses\n\nPost-Study Follow-up: until 1 year after administration', 'interventionNames': ['Drug: TGF-β2 antisense oligonucleotide', 'Procedure: Trabeculectomy']}], 'interventions': [{'name': 'TGF-β2 antisense oligonucleotide', 'type': 'DRUG', 'otherNames': ['ISTH0036'], 'description': 'intravitreal injection', 'armGroupLabels': ['TGF-β2 antisense oligonucleotide']}, {'name': 'Trabeculectomy', 'type': 'PROCEDURE', 'description': 'Standard trabeculectomy with the use of antimetabolites (mitomycin C) for glaucoma patients with insufficient intraocular pressure (IOP) control', 'armGroupLabels': ['TGF-β2 antisense oligonucleotide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '39120', 'city': 'Magdeburg', 'country': 'Germany', 'facility': 'University Hospital Magdeburg, Ophthalmology', 'geoPoint': {'lat': 52.13129, 'lon': 11.63189}}, {'zip': '55131', 'city': 'Mainz', 'country': 'Germany', 'facility': 'Department of Ophthalmology, Johannes-Gutenberg University Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University of Tuebingen, Center of Ophthalmology', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Petra Fettes, PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Isarna Therapeutics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Isarna Therapeutics GmbH', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}