Ignite Creation Date:
2025-12-24 @ 12:15 PM
Ignite Modification Date:
2026-01-02 @ 8:28 AM
Study NCT ID:
NCT05112861
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-04-02
First Post:
2021-10-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D057135', 'term': 'Wet Macular Degeneration'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 120}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2021-11-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2021-10-28', 'studyFirstSubmitQcDate': '2021-10-28', 'lastUpdatePostDateStruct': {'date': '2024-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-11-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency and incidence of treatment-emergent adverse events following intravitreal injections of ONS-5010 in vials or PFS', 'timeFrame': '3 months'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration', 'Neovascular Age-related Macular Degeneration', 'Wet Macular Degeneration', 'BRVO - Branch Retinal Vein Occlusion', 'Diabetic Macular Edema']}, 'descriptionModule': {'briefSummary': 'The study will compare the safety of ophthalmic bevacizumab in vials versus pre-filled syringes in subjects diagnosed with a retinal condition that would benefit from treatment with intravitreal injection of bevacizumab, including: exudative age-related macular degeneration, diabetic macular edema, or branch retinal vein occlusion.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active clinical diagnosis and OCT confirmation of one of the following retinal disorders: exudative age-related macular degeneration (AMD), diabetic macular edema (DME), or branch retinal vein occlusion (BRVO) and, in the opinion of the Investigator, requires treatment with an anti-VEGF therapy\n\nExclusion Criteria:\n\n* Previous use of approved anti-VEGF or Avastin® within 4 weeks preceding randomization\n* Previous use of Beovu®\n* Macular edema due to something other than exudative AMD, DME or BRVO, in the study eye\n* History of inadequate response to previous intravitreal anti-VEGF therapy\n* History of any intraocular or periocular corticosteroid injection or implant, in the study eye\n* Laser photocoagulation (juxtafoveal or extrafoveal) in the study eye within 1-month preceding randomization\n* Any concurrent intraocular condition in the study eye that may require medical or surgical intervention or contribute to vision loss during the study period\n* Active intraocular inflammation in the study eye\n* Current vitreous hemorrhage in the study eye\n* Polypoidal choroidal vasculopathy (PCV) in the study eye\n* History of idiopathic, infectious or autoimmune-associated uveitis in either eye\n* Current ocular or periocular infection, such as conjunctivitis, keratitis, scleritis, or endophthalmitis in either eye\n* Uncontrolled glaucoma in the study eye (defined as intraocular pressure ≥30 mmHg despite treatment with anti-glaucoma medication)\n* Premenopausal women not using adequate contraception\n* Current treatment for active systemic infection\n* Known allergy to any component of the study drug , not amenable to treatment'}, 'identificationModule': {'nctId': 'NCT05112861', 'acronym': 'NORSE SEVEN', 'briefTitle': 'A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus Pre-filled Syringe in Subjects With Visual Impairment Due to Retinal Disorders', 'organization': {'class': 'INDUSTRY', 'fullName': 'Outlook Therapeutics, Inc.'}, 'officialTitle': 'A 3-month Study to Compare the Safety of ONS-5010 in Vials Versus PFS in Subjects With Visual Impairment Due to Retinal Disorders, NORSE SEVEN', 'orgStudyIdInfo': {'id': 'ONS-5010-007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Biological: bevacizumab', 'interventionNames': ['Biological: bevacizumab']}], 'interventions': [{'name': 'bevacizumab', 'type': 'BIOLOGICAL', 'otherNames': ['ONS-5010'], 'description': '1.25 mg, intravitreal injection', 'armGroupLabels': ['Biological: bevacizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '21740', 'city': 'Hagerstown', 'state': 'Maryland', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 39.64176, 'lon': -77.71999}}, {'zip': '17201', 'city': 'Chambersburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 39.93759, 'lon': -77.6611}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Outlook Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}