Ignite Creation Date:
2025-12-24 @ 5:01 PM
Ignite Modification Date:
2026-01-02 @ 3:03 AM
Study NCT ID:
NCT03488550
Status:
COMPLETED
Last Update Posted:
2020-08-20
First Post:
2018-03-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005902', 'term': 'Glaucoma, Open-Angle'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 9}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-03-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-19', 'studyFirstSubmitDate': '2018-03-28', 'studyFirstSubmitQcDate': '2018-04-03', 'lastUpdatePostDateStruct': {'date': '2020-08-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-08-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Effect of a single IVT injection of ANX007 on serum C1q', 'timeFrame': 'Day 15'}], 'primaryOutcomes': [{'measure': 'Safety and tolerability as measured by the occurrence of adverse events', 'timeFrame': 'Day 56'}], 'secondaryOutcomes': [{'measure': 'Serum plasma concentration of ANX007 after a single IVT injection.', 'timeFrame': 'Day 15'}, {'measure': 'Immunogenicity of ANX007 after a single IVT injection.', 'timeFrame': 'Day 56'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Open-angle Glaucoma']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.annexonbio.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'This is a multi center, open-label, single dose, safety study. Approximately 9 to 15 participants with open-angle glaucoma are assigned into 3 sequential dose-levels and will receive ANX007 administered as single, IVT injections.', 'detailedDescription': 'This is a phase 1, open-label, dose-escalation, safety study evaluating up to 3 dose levels of ANX007 administered as single IVT injections. Approximately 9 to 15 eligible participants are enrolled into one cohort each. All participants receive ANX007 in an open-label manner. The primary objective is to evaluate the safety and tolerability of a single intravitreal (IVT) injection of ANX007 in participants with primary open-angle glaucoma. Secondary objectives are to evaluate the serum pharmacokinetics (PK) and immunogenicity. An exploratory objective will evaluate the pharmacodynamic (PD) effect of ANX007 on serum C1q activity.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female age 18 years and older\n* Diagnosis of primary open-angle glaucoma\n* Intraocular pressure \\<21 mm Hg on a stable IOP treatment regimen\n* Reliable visual field testing\n\nExclusion Criteria:\n\n* BCVA worse than 20/80 in either eye\n* Extensive glaucomatous visual-field damage\n* History of intraocular inflammatory or infectious eye disease in study eye\n* Ocular trauma in study eye within the preceding 6 months\n* History of uncomplicated cataract surgery less than 6 mos prior\n* Any abnormality preventing reliable Tonopen tonometry in study eye\n* Active malignancy within past 5 yrs\n* Previous tx with another humanized monoclonal antibody\n* History of any autoimmune or neurologic disease\n* Concurrent use of glucocorticoid medications\n* Receiving monoamine oxidase inhibitor therapy'}, 'identificationModule': {'nctId': 'NCT03488550', 'briefTitle': 'Single-dose Study of ANX007 in Participants With Primary Open-angle Glaucoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Annexon, Inc.'}, 'officialTitle': 'A Phase 1, Open-label, Single-dose, Dose-escalation, Safety, Tolerability, and PK Study of Intravitreal ANX007 in Participants With Primary Open-angle Glaucoma', 'orgStudyIdInfo': {'id': 'ANX007-GLA-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ANX007-GLA-01', 'interventionNames': ['Biological: ANX007']}], 'interventions': [{'name': 'ANX007', 'type': 'BIOLOGICAL', 'description': 'Single ascending dose', 'armGroupLabels': ['ANX007-GLA-01']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92663', 'city': 'Newport Beach', 'state': 'California', 'country': 'United States', 'facility': 'Eye Research Foundation', 'geoPoint': {'lat': 33.61891, 'lon': -117.92895}}], 'overallOfficials': [{'name': 'Eric Humphriss', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Annexon Vice President of Clinical Operations'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Annexon, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}