Ignite Creation Date:
2025-12-25 @ 1:10 AM
Ignite Modification Date:
2025-12-25 @ 11:21 PM
Study NCT ID:
NCT06274593
Status:
RECRUITING
Last Update Posted:
2025-01-16
First Post:
2024-02-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D005901', 'term': 'Glaucoma'}], 'ancestors': [{'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-04-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-14', 'studyFirstSubmitDate': '2024-02-14', 'studyFirstSubmitQcDate': '2024-02-21', 'lastUpdatePostDateStruct': {'date': '2025-01-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-02-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-04-27', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare the progression of vascular density (VD) in advanced glaucoma patients.', 'timeFrame': '3 year', 'description': 'Progression of peripapillary vascular density (VD) (in percent) per sector (8 sectors) with 3-year follow-up.'}, {'measure': 'Compare the progression of peripapillary retinal nerve fiber (RNFL) thickness) in advanced glaucoma patients.', 'timeFrame': '3 year', 'description': 'Progression of peripapillary nerve fiber thickness (RNFL, in µm) per sector (8 sectors) with 3-year follow-up.'}, {'measure': 'Compare the progression of visual field in advanced glaucoma patients.', 'timeFrame': '3 year', 'description': 'Progression of visual field deficit (in dB) by sector (8 sectors) with 3-year follow-up'}], 'secondaryOutcomes': [{'measure': 'CV-OCTrnfl correlation study and CV-OCTa correlation study on measurements made at inclusion and on measurements made during follow-up', 'timeFrame': '3 years', 'description': 'Study of the correlation between CV-OCTrnfl and correlation between CV-OCTa (mean in µm)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['glaucoma', 'OCTa', 'OCTrnfl'], 'conditions': ['Glaucoma']}, 'descriptionModule': {'briefSummary': "Glaucoma is a chronic disease of the optic nerve, characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world's second leading cause of blindness after cataracts, and the leading cause of irreversible blindness.\n\nTo date, to our knowledge, there is no work analyzing the progression of angiographic OCT in patients with glaucoma.\n\nThe main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).", 'detailedDescription': 'Glaucoma is a chronic disease of the optic nerve characterized by progressive loss of nerve cells in the retina, leading to progressive loss of peripheral and central vision. There are in fact several types of glaucoma, which is the world\'s second-leading cause of blindness after cataracts and the leading cause of irreversible blindness.\n\nThe pathophysiology and loss of retinal ganglion cells are partly explained by 2 main theories:\n\n* biomechanical theory, which takes into account the forces and deformations of the optic nerve linked to IOP (intraocular pressure) and to the anatomy of the optic nerve head, particularly at the level of the cribriform plate (a zone of deformable weakness surrounded by a rigid scleral shell),\n* the vascular theory, explained by abnormalities in the vascularization of the optic nerve and retina.\n\nOptical coherence tomography angiography (OCTa) is a relatively new imaging method that has been on the market for around ten years.\n\nIt is a non-invasive method that provides qualitative and quantitative information on retinal vascularization and the optic nerve head. The movement of red blood cells is used as a contrast medium to differentiate blood vessels from static tissue.\n\nIn glaucoma, changes in the peripapillary vascular plexus (around the optic nerve head) can be observed and are topographically correlated with visual field and peripapillary nerve fiber deficits.\n\nOne of the challenges in monitoring glaucoma patients lies in detecting the progression of the disease with the help of various complementary examinations, including the visual field, peripapillary nerve fiber OCT (RNFL), and more recently, OCTa.\n\nThe visual field is used to detect areas of vision deficit (peripheral or sometimes central), known as scotomas, and to monitor their evolution. RNFL OCT measures the thickness of the optic nerve (in micrometers) in its various quadrants. OCTa measures vascular density, also by quadrant, around the optic nerve head.\n\nA deterioration in any of these parameters can help guide therapeutic management by modifying medical treatment or proposing surgery to lower intraocular pressure in the affected eye.\n\nOne of the difficulties in monitoring glaucoma patients lies in detecting optic nerve thinning in patients with advanced optic nerve damage. It is now well known that at an advanced stage of the disease, measurement of optic nerve thickness on RNFL OCT can reach a "floor" effect: residual non-neuronal tissue limits the usefulness of detecting changes in neuronal tissue, and disease progression can only be detected by visual field monitoring.\n\nVascular density measured on OCTa appears to reach a plateau effect in a delayed manner compared with measurements obtained on peripapillary OCT (RNFL) and could enable better monitoring of disease progression in patients with advanced glaucoma.\n\nIndeed, a new objective follow-up criterion measured with OCTa in clinical practice for patients with uninterpretable OCTrnfl would be a valuable tool for assessing the rate of glaucoma progression in these patients and thus defining the rate of monitoring and the decision to intensify treatment in the event of progression. This is all the more important as the treatments available for glaucoma are sometimes invasive (drainage devices, surgery, etc.). Assessing the benefit-risk balance therefore requires objective data for these patients.\n\nTo date, to our knowledge, there are no studies analyzing the evolution of OCT angiography in glaucoma patients.\n\nThe main aim of this study is to compare the 3-year progression rate of 3 examinations in advanced glaucoma patients: one functional (visual field) and two anatomical (OCTa and OCTrnfl).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients followed at Nantes University Hospital for advanced glaucoma (MD\\>10dB in visual field) who had peripapillary angiography OCT, OCTrnfl and visual field at their follow-up consultation.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women aged 18 and over\n* Patient with glaucoma followed in the ophthalmology department of Nantes University Hospital\n* mean visual field deficit (MD) \\>10dB\n\nExclusion Criteria:\n\n* Retinal vascular pathology (moderate to severe non-proliferative diabetic retinopathy, complicated diabetic retinopathy, OVCR/OBVR, OACR/OBAR, NOIAA...) Non-glaucomatous optic neuropathy, neurological pathology leading to visual field deficit (stroke with HLH, quadranopsia, chiasmatic Sd...)\n* PPR (retinal PanPhotocoagulation), retinal cerclage\n* Retinal pathology leading to visual field impairment (e.g. retinitis pigmentosa)\n* AMD and other macular pathologies that can lead to central visual field deficits\n* Significant environmental disorders impairing retinal imaging (e.g. active uveitis, dense cataract)\n* Loss of fixation point preventing visual field formation Pregnant or breast-feeding women\n* Protected adults under guardianship or curatorship\n* with unreliable visual fields (false positives and false negatives \\> 33%)\n* with an uninterpretable OCTrnfl or OCTa (artifact, low quality score)'}, 'identificationModule': {'nctId': 'NCT06274593', 'acronym': 'OGA', 'briefTitle': 'Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Study of OCT Peripapillary Angiography in Patients With Advanced Glaucoma', 'orgStudyIdInfo': {'id': 'AP_JBD_MJ_003'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OCT', 'type': 'DEVICE', 'description': 'Peripapillary angiography (OCT) at baseline and each year during 3 year'}]}, 'contactsLocationsModule': {'locations': [{'zip': '44000', 'city': 'Nantes', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Ducloyer, MD; PhD', 'role': 'CONTACT', 'email': 'alexandra.poinas@chu-nantes.fr'}], 'facility': 'CHU Nantes', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}, {'zip': '44093', 'city': 'Nantes', 'status': 'NOT_YET_RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jean-Baptiste Ducloyer, MD', 'role': 'CONTACT', 'email': 'jeanbaptiste.ducloyer@chu-nantes.fr'}], 'facility': 'Jean-Baptiste Ducloyer', 'geoPoint': {'lat': 47.21725, 'lon': -1.55336}}], 'centralContacts': [{'name': 'Jean-Baptiste Ducloyer, M.D', 'role': 'CONTACT', 'email': 'jeanbatiste.ducloyer@chu-nantes.fr', 'phone': '02 40 08 34 01'}, {'name': 'Isabelle Orignac, M.D', 'role': 'CONTACT', 'email': 'isabelle.orignac@chu-nantes.fr', 'phone': '02 40 08 34 01'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}