Ignite Creation Date:
2025-12-25 @ 1:08 AM
Ignite Modification Date:
2026-02-26 @ 4:17 PM
Study NCT ID:
NCT03669393
Status:
COMPLETED
Last Update Posted:
2020-09-02
First Post:
2018-09-10
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D058456', 'term': 'Retinal Telangiectasis'}, {'id': 'C548027', 'term': 'Idiopathic Juxtafoveal Retinal Telangiectasia'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D013684', 'term': 'Telangiectasis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C569915', 'term': 'TB-403'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 8}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-09', 'completionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-09-01', 'studyFirstSubmitDate': '2018-09-10', 'studyFirstSubmitQcDate': '2018-09-11', 'lastUpdatePostDateStruct': {'date': '2020-09-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from baseline in central subfield thickness (CST), based on spectral domain optical coherence tomography (SD-OCT)', 'timeFrame': 'At Day 84 (Month 3)'}], 'secondaryOutcomes': [{'measure': 'Change from baseline in CST, based on SD-OCT, by study visit', 'timeFrame': 'From baseline to Day 140'}, {'measure': 'Change from baseline in area of cystoid spaces, based on SD-OCT, by study visit', 'timeFrame': 'From baseline to Day 140'}, {'measure': 'Change from baseline in best-corrected visual acuity (BCVA), by study visit', 'timeFrame': 'From Day 0 to Day 140'}, {'measure': 'Incidence of systemic and ocular adverse events including serious adverse events', 'timeFrame': 'From Day 0 to Day 140'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Retinal Telangiectasis', 'Idiopathic Juxtafoveal Retinal Telangiectasia']}, 'descriptionModule': {'briefSummary': "This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in reducing central subfield thickness (CST) and improving best-corrected visual acuity (BCVA) in subjects with macular telangiectasia Type 1 (MacTel 1)."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female aged 18 years or older\n* Macular oedema caused by MacTel 1, with CST \\>300µm on SD-OCT\n* Written informed consent obtained from the subject prior to screening procedures\n\nExclusion Criteria:\n\n* Type 1 or type 2 Diabetes Mellitus\n* Concurrent disease in the study eye that could require medical or surgical intervention during the study period for up to 30 days after the last study treatment, or could confound interpretation of the results\n* Previous confounding treatments / procedures, or their planned / expected use during the study period for up to 30 days after the last administration of study treatment\n* Any active ocular / intraocular infection or inflammation in either eye\n* Pregnant or lactating female, or female of child-bearing potential not utilising an adequate form of contraception, or male of reproductive potential not utilising contraception'}, 'identificationModule': {'nctId': 'NCT03669393', 'briefTitle': 'A Study to Evaluate THR-317 Treatment for Macular Telangiectasia Type 1 (MacTel 1)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Oxurion'}, 'officialTitle': 'A Phase 2, Open-label, Multi-centre Study to Assess the Efficacy and Safety of Intravitreal THR-317 for the Treatment of Macular Telangiectasia Type 1 (MacTel 1)', 'orgStudyIdInfo': {'id': 'THR-317-003'}, 'secondaryIdInfos': [{'id': '2017-004010-26', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THR-317', 'interventionNames': ['Drug: THR-317 8mg']}], 'interventions': [{'name': 'THR-317 8mg', 'type': 'DRUG', 'description': '3 intravitreal injections of THR-317 8mg, approximately 1 month apart', 'armGroupLabels': ['THR-317']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75010', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Lariboisière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '75181', 'city': 'Paris', 'country': 'France', 'facility': 'Hôpital Cochin', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '1000', 'city': 'Lausanne', 'country': 'Switzerland', 'facility': 'Hôpital Ophtalmique Jules-Gonin', 'geoPoint': {'lat': 46.516, 'lon': 6.63282}}], 'overallOfficials': [{'name': 'Clinical Department', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Oxurion NV.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ThromboGenics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}