Ignite Creation Date:
2025-12-25 @ 1:12 AM
Ignite Modification Date:
2025-12-27 @ 2:44 AM
Study NCT ID:
NCT06190093
Status:
COMPLETED
Last Update Posted:
2025-02-25
First Post:
2023-12-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)
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'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000068258', 'term': 'Bevacizumab'}, {'id': 'D000069579', 'term': 'Ranibizumab'}], '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': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 400}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-21', 'studyFirstSubmitDate': '2023-12-19', 'studyFirstSubmitQcDate': '2023-12-19', 'lastUpdatePostDateStruct': {'date': '2025-02-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-01-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-11-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluate the effectiveness of intravitreal injections of ONS-5010 compared to ranibizumab in preventing vision loss, as measured by the mean change in baseline best correct visual acuity (BCVA) at Week 8', 'timeFrame': 'Baseline, 8 weeks', 'description': 'BCVA to be assessed as letters read using the Early Treatment Diabetic Retinopathy Study (ETDRS) charts. A positive change represents an improvement in visual acuity.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neovascular Age-related Macular Degeneration', 'Age-Related Macular Degeneration', 'Wet Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Multicenter, randomized, masked, controlled study of the safety and effectiveness of intravitreally administered ONS-5010.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Active primary Subfoveal Choroidal Neovascularization lesions secondary to Age-related macular degeneration (AMD) in the study eye\n* Best corrected visual acuity of 35-75 letters read (20/32 to 20/200 Snellen equivalent)\n* Study eye must:\n* Have active leakage on Fluorescein Angiogram involving the fovea\n* Have edema involving the fovea\n* Be free of scarring, fibrosis, or atrophy involving the central foveal zone\n\nExclusion Criteria:\n\n* Previous subfoveal focal laser photocoagulation 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 within 1 year\n* Active intraocular inflammation (grade trace or above) 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 or autoimmune-associated uveitis in either eye\n* Infectious 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 or history of allergy to fluorescein , not amenable to treatment'}, 'identificationModule': {'nctId': 'NCT06190093', 'briefTitle': 'A 3-month Study to Assess the Safety and Effectiveness of ONS-5010 in Subjects with Neovascular Age-related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Outlook Therapeutics, Inc.'}, 'officialTitle': 'Safety and Effectiveness of ONS-5010 Compared to Lucentis® in Subjects with Neovascular Age-related Macular Degeneration; NORSE EIGHT', 'orgStudyIdInfo': {'id': 'ONS-5010-008'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ONS-5010 bevacizumab', 'interventionNames': ['Biological: bevacizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'ranibizumab', 'interventionNames': ['Biological: ranibizumab']}], 'interventions': [{'name': 'bevacizumab', 'type': 'BIOLOGICAL', 'otherNames': ['ONS-5010'], 'description': '1.25 mg, intravitreal injection', 'armGroupLabels': ['ONS-5010 bevacizumab']}, {'name': 'ranibizumab', 'type': 'BIOLOGICAL', 'description': '0.5mg, intravitreal injection', 'armGroupLabels': ['ranibizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91006', 'city': 'Arcadia', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 34.13973, 'lon': -118.03534}}, {'zip': '93309', 'city': 'Bakersfield', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 35.37329, 'lon': -119.01871}}, {'zip': '90210', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '92647', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Clinical Site', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '92653', 'city': 'Laguna Hills', 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