Ignite Creation Date:
2025-12-25 @ 3:07 AM
Ignite Modification Date:
2025-12-26 @ 1:47 AM
Study NCT ID:
NCT06015633
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-02-21
First Post:
2023-08-23
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Ocular, Vascular, and Genetic Findings in AMD Patients
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-10-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-05-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-02-19', 'studyFirstSubmitDate': '2023-08-23', 'studyFirstSubmitQcDate': '2023-08-23', 'lastUpdatePostDateStruct': {'date': '2025-02-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'OCT-A', 'timeFrame': 'Baseline observation of incidence / correlation only', 'description': 'OCT-A metrics in subjects with AMD'}], 'secondaryOutcomes': [{'measure': 'Genetic markers related to AMD', 'timeFrame': 'Baseline observation of incidence / correlation only', 'description': 'Presence of 52 known AMD related genetic markers'}, {'measure': 'Magnetic Resonance Angiography', 'timeFrame': 'Baseline observation of incidence / correlation only', 'description': 'Ophthalmic artery MRI / MRA results in subjects with AMD'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Observation of findings associated with AMD', 'detailedDescription': 'Explorational observation of ocular, vascular, and genetic findings in patients diagnosed with AMD'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects with exudative or non-exudative late-stage age-related macular degeneration.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. At least 55 years of age at the time of consent\n2. Able to understand and provide written informed consent\n3. Sufficiently clear ocular media, adequate pupillary dilation, and adequate fixation to permit quality fundus imaging\n4. Able to cooperate with ophthalmic visual function testing and anatomic assessments\n5. Diagnosed with late-stage AMD in at least one eye. (if both eyes of an eligible subject meet inclusion criterion, the more advanced eye will receive primary eye assignment)\n6. Willing to have protocol specified genetic testing\n7. Willing to have head coil MRI/A (with contrast if deemed necessary)\n\nExclusion Criteria:\n\nOcular\n\n1. History of any retinal disease other than AMD in either eye\n2. Spherical equivalent refractive error demonstrating \\>6 diopters of myopia or an axial length \\>26 mm in the study eye\n3. History of vitrectomy in the study eye\n4. Any intraocular surgery (including lens replacement surgery) in the study eye, within 90 days of enrollment\n5. History of endophthalmitis\n6. Trabeculectomy or aqueous shunt or valve in the study eye\n7. Aphakia or absence of the posterior capsule in the study eye (Note: Previous violation of the posterior capsule is also excluded unless it occurred as a result of yttrium aluminum garnet \\[YAG\\] laser posterior capsulotomy in association with prior posterior chamber intraocular lens implantation and at least 90 days prior to enrollment)\n8. Presence of advanced guttae or visually significant keratopathy that would cause scattering of light or alter visual function in the study eye\n9. History of idiopathic or autoimmune-associated uveitis in either eye\n10. Active inflammation or infection, including conjunctivitis, keratitis, or scleritis in either eye\n11. GA secondary to a condition other than AMD (e.g., Stargardt's disease, cone rod dystrophy, or toxic maculopathies such as Plaquenil maculopathy) in either eye\n\n Non-Ocular\n12. Use of any investigational product or investigational medical device (i.e., not approved by FDA for the specific use) within 90 days prior to screening or anticipated use during the study\n13. Women of childbearing potential who are pregnant or unwilling to use effective contraception for the duration of the study\n14. Acute or serious illness, in the opinion of the site investigator\n15. History of kidney failure or gadolinium toxicity"}, 'identificationModule': {'nctId': 'NCT06015633', 'briefTitle': 'Ocular, Vascular, and Genetic Findings in AMD Patients', 'organization': {'class': 'INDUSTRY', 'fullName': 'OcuDyne, Inc.'}, 'officialTitle': 'Exploration of Ocular, Vascular, and Genetic Findings Associated and Correlated with the Presence of Late-stage AMD', 'orgStudyIdInfo': {'id': 'OC-2301TV'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Exudative AMD', 'description': 'Subjects that have at least one eye with a history of, or active, exudative age related macular degeneration', 'interventionNames': ['Other: No intervention']}, {'label': 'Non-exudative AMD', 'description': 'Subjects that have at least one eye with late stage non-exudative age-related macular degeneration (presence of geographic atrophy)', 'interventionNames': ['Other: No intervention']}], 'interventions': [{'name': 'No intervention', 'type': 'OTHER', 'description': 'Observational only', 'armGroupLabels': ['Exudative AMD', 'Non-exudative AMD']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Tel Aviv', 'country': 'Israel', 'facility': 'Tel Aviv Sourasky Medical Center', 'geoPoint': {'lat': 32.08088, 'lon': 34.78057}}], 'overallOfficials': [{'name': 'Luana Wilbur, BS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'OcuDyne VP, Clinical and Regulatory Affairs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'OcuDyne, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}