Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2026-04-18 @ 11:23 AM
Study NCT ID:
NCT03071068
Status:
COMPLETED
Last Update Posted:
2018-04-17
First Post:
2017-02-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}, {'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-12-22', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-16', 'studyFirstSubmitDate': '2017-02-21', 'studyFirstSubmitQcDate': '2017-02-28', 'lastUpdatePostDateStruct': {'date': '2018-04-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Incidence of acute (up to the 7-day follow-up visit) ocular (serious) adverse events ([S]AEs) in the study eye, after each injection and across injections per subject', 'timeFrame': 'up to the 7-day follow-up visit after each injection'}], 'secondaryOutcomes': [{'measure': 'Incidence of systemic and ocular (S)AEs up to the 30-day follow-up visit, after each injection and across injections per subject', 'timeFrame': 'up to the 30-day follow-up visit after each injection'}, {'measure': 'Incidence of systemic and ocular (S)AEs from first injection up to Day 90 and up to Day 150', 'timeFrame': 'From day 0 to day 150'}, {'measure': 'Proportion of subjects withdrawn from repeat injection and reason for withdrawal', 'timeFrame': 'At day 30 and at day 60'}, {'measure': 'Proportion of subjects with a loss of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA from baseline by study visit', 'timeFrame': 'Up to day 150'}, {'measure': 'Proportion of subjects with an acute loss (up to the 7-day follow-up visit) of ≥ 15, ≥ 10 or ≥ 5 ETDRS letters in BCVA after each injection', 'timeFrame': 'Up to 7-day follow-up visit after each injection'}, {'measure': 'Proportion of subjects with a ≥ 15 ETDRS letters gain in BCVA from baseline or ≥ 83 ETDRS letters, by study visit', 'timeFrame': 'Up to day 150'}, {'measure': 'Mean change from baseline in BCVA, by study visit', 'timeFrame': 'Up to day 150'}, {'measure': 'Mean change from baseline in CST, by study visit, based on spectral domain optical coherence tomography (SD-OCT), as assessed by the central reading centre (CRC)', 'timeFrame': 'Up to day 150'}]}, 'conditionsModule': {'conditions': ['Diabetic Retinopathy', 'Macular Edema']}, 'descriptionModule': {'briefSummary': "This study is conducted to evaluate the safety of THR-317 when administered intravitreally and to assess the compound's efficacy in improving best-corrected visual acuity (BCVA) and reducing central subfield thickness (CST) in subjects with centre-involved diabetic macular oedema (DME)."}, '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* Type 1 or type 2 diabetes\n* Centre-involved DME with CST ≥ 340µm on Spectralis SD-OCT or ≥ 320µm on non-Spectralis SD OCT, in the study eye\n* Reduced vision primarily due to DME, with BCVA between 72 and 23 ETDRS letters read at 4 meters (20/40 and 20/320 Snellen equivalent) in the study eye\n* Anti-vascular endothelial growth factor (anti-VEGF) treatment naïve study eye or poor response to prior anti-VEGF treatment in the study eye\n* Non-proliferative diabetic retinopathy, or stable proliferative diabetic retinopathy without neovacularisation at the disc\n* Written informed consent obtained from the subject prior to screening procedures\n\nExclusion criteria:\n\n* Concurrent disease in the study eye, other than DME, that could compromise BCVA, require medical or surgical intervention during the study period or could confound interpretation of the results\n* Previous treatments / procedures in the study eyes as follows, or their planned use during the THR-317 treatment period for up to 30 days after the last injection: panretinal or focal / grid laser photocoagulation \\[3 months\\], anti-VEGF treatment \\[any time for anti-VEGF naïve subjects; 4 weeks for subjects with a poor response to anti-VEGF treatment\\], intra-ocular or peri-ocular corticosteroids \\[4 months\\], steroid implant \\[any time\\], intra-ocular surgery \\[3 months\\], vitrectomy \\[any time\\]\n* Any active ocular / intra-ocular infection or inflammation in either eye\n* Aphakic study eye\n* Untreated diabetes\n* Glycated haemoglobin A (HbA1c) \\> 12%\n* Uncontrolled hypertension in the opinion of the Investigator\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 suggesting lens / zonular instability'}, 'identificationModule': {'nctId': 'NCT03071068', 'briefTitle': 'A Study to Evaluate the Safety and Efficacy of THR-317 for the Treatment of Diabetic Macular Oedema (DME)', 'organization': {'class': 'INDUSTRY', 'fullName': 'ThromboGenics'}, 'officialTitle': 'A Phase 2, Single-masked, Multicentre Study to Evaluate the Safety and Efficacy of 2 Dose Levels of THR-317 for the Treatment of Diabetic Macular Oedema (DME)', 'orgStudyIdInfo': {'id': 'THR-317-001'}, 'secondaryIdInfos': [{'id': '2016-002100-25', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'THR-317 4mg', 'description': 'anti-PlGF recombinant monoclonal antibody, 4mg dose', 'interventionNames': ['Drug: Anti-PlGF recombinant monoclonal antibody, 4mg dose']}, {'type': 'EXPERIMENTAL', 'label': 'THR-317 8mg', 'description': 'anti-PlGF recombinant monoclonal antibody, 8mg dose', 'interventionNames': ['Drug: Anti-PlGF recombinant monoclonal antibody, 8mg dose']}], 'interventions': [{'name': 'Anti-PlGF recombinant monoclonal antibody, 4mg dose', 'type': 'DRUG', 'description': '3 intravitreal injections of THR-317 4mg approximately 1 month apart', 'armGroupLabels': ['THR-317 4mg']}, {'name': 'Anti-PlGF recombinant monoclonal antibody, 8mg dose', 'type': 'DRUG', 'description': '3 intravitreal injections of THR-317 8mg approximately 1 month apart', 'armGroupLabels': ['THR-317 8mg']}]}, 'contactsLocationsModule': {'locations': [{'zip': '625 00', 'city': 'Brno', 'country': 'Czechia', 'geoPoint': {'lat': 49.19522, 'lon': 16.60796}}, {'zip': '500 05', 'city': 'Hradec Králové', 'country': 'Czechia', 'geoPoint': {'lat': 50.20923, 'lon': 15.83277}}, {'zip': '100 34', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '180 00', 'city': 'Prague', 'country': 'Czechia', 'geoPoint': {'lat': 50.08804, 'lon': 14.42076}}, {'zip': '1083', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '1133', 'city': 'Budapest', 'country': 'Hungary', 'geoPoint': {'lat': 47.49835, 'lon': 19.04045}}, {'zip': '4032', 'city': 'Debrecen', 'country': 'Hungary', 'geoPoint': {'lat': 47.53167, 'lon': 21.62444}}, {'zip': '7621', 'city': 'Pécs', 'country': 'Hungary', 'geoPoint': {'lat': 46.07617, 'lon': 18.22814}}, {'zip': '6720', 'city': 'Szeged', 'country': 'Hungary', 'geoPoint': {'lat': 46.253, 'lon': 20.14824}}, {'zip': '826 06', 'city': 'Bratislava', 'country': 'Slovakia', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '851 07', 'city': 'Bratislava', 'country': 'Slovakia', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'zip': '911 71', 'city': 'Trenčín', 'country': 'Slovakia', 'geoPoint': {'lat': 48.89452, 'lon': 18.04436}}, {'zip': '012 07', 'city': 'Žilina', 'country': 'Slovakia', 'geoPoint': {'lat': 49.22315, 'lon': 18.73941}}], 'overallOfficials': [{'name': 'Clinical Department', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ThromboGenics'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'ThromboGenics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}