Ignite Creation Date:
2025-12-25 @ 4:32 AM
Ignite Modification Date:
2026-03-03 @ 2:20 PM
Study NCT ID:
NCT03758118
Status:
COMPLETED
Last Update Posted:
2023-11-24
First Post:
2018-11-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Citicoline in Non-Arteritic Ischemic Optic Neuropathy
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D003566', 'term': 'Cytidine Diphosphate Choline'}], 'ancestors': [{'id': 'D002794', 'term': 'Choline'}, {'id': 'D050337', 'term': 'Trimethyl Ammonium Compounds'}, {'id': 'D000644', 'term': 'Quaternary Ammonium Compounds'}, {'id': 'D000588', 'term': 'Amines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D009861', 'term': 'Onium Compounds'}, {'id': 'D003565', 'term': 'Cytidine Diphosphate'}, {'id': 'D003597', 'term': 'Cytosine Nucleotides'}, {'id': 'D011742', 'term': 'Pyrimidine Nucleotides'}, {'id': 'D011743', 'term': 'Pyrimidines'}, {'id': 'D006573', 'term': 'Heterocyclic Compounds, 1-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}, {'id': 'D009711', 'term': 'Nucleotides'}, {'id': 'D009706', 'term': 'Nucleic Acids, Nucleotides, and Nucleosides'}, {'id': 'D012265', 'term': 'Ribonucleotides'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'vmparisi@gmail.com', 'phone': '+390686356727', 'title': 'Dr, Vincenzo Parisi', 'organization': 'IRCCS Fondazione Bietti'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '9 months', 'description': 'No adverse events were observed in any patient enrolled', 'eventGroups': [{'id': 'EG000', 'title': 'NAION Patients OS-Citicoline Treated', 'description': '19 NAION patients providing 19 eyes completed the study', 'otherNumAtRisk': 19, 'deathsNumAtRisk': 19, 'otherNumAffected': 0, 'seriousNumAtRisk': 19, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'NAION Patients Untreated', 'description': '17 NAION patients providing 17 eyes completed the study', 'otherNumAtRisk': 17, 'deathsNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change From Baseline in Visual Acuity at 9 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NAION Patients OS-Citicoline Treated', 'description': '19 eyes completed the study, 1 eye drop-out'}, {'id': 'OG001', 'title': 'NAION Patients Untreated', 'description': '17 eyes completed the study, 3 eyes drop-out'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.0574', 'spread': '0.1147', 'groupId': 'OG000'}, {'value': '0.0535', 'spread': '0.0914', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months vs baseline', 'description': 'Increase of Visual Acuity evaluated by Early Treatment Diabetic Retinopathy Study (ETDRS) charts and measured as a logarithm of the minimum angle of resolution (LogMAR)', 'unitOfMeasure': 'LogMAR', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Retinal Ganglion Cells Function at 9 Month', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NAION Patients OS-Citicoline Treated', 'description': '19 eyes completed the study, 1 eye drop-out'}, {'id': 'OG001', 'title': 'NAION Patients Untreated', 'description': '17 eyes completed the study, 3 eyes drop-out'}], 'classes': [{'categories': [{'measurements': [{'value': '1.32', 'spread': '0.39', 'groupId': 'OG000'}, {'value': '1.38', 'spread': '0.28', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months vs Baseline', 'description': 'Pattern-Electroretinogram recordings. Increase of P50-N95 amplitude (measured in microvolt)', 'unitOfMeasure': 'microvolt', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Optic Nerve Function at 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NAION Patients OS-Citicoline Treated', 'description': '19 eyes completed the study, 1 eye drop-out'}, {'id': 'OG001', 'title': 'NAION Patients Untreated', 'description': '17 eyes completed the study, 3 eyes drop-out'}], 'classes': [{'categories': [{'measurements': [{'value': '127.05', 'spread': '8.35', 'groupId': 'OG000'}, {'value': '126.88', 'spread': '6.50', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months vs baseline', 'description': 'Visual Evoked Potentials recordings. Shortening of the main parameter P100 Implicit time measured in milliseconds', 'unitOfMeasure': 'milliseconds', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Optic Nerve Morphology at 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NAION Patients OS-Citicoline Treated', 'description': '19 eyes completed the study, 1 eye drop-out'}, {'id': 'OG001', 'title': 'NAION Patients Untreated', 'description': '17 eyes completed the study, 3 eyes drop-out'}], 'classes': [{'categories': [{'measurements': [{'value': '57.71', 'spread': '9.43', 'groupId': 'OG000'}, {'value': '63.99', 'spread': '8.44', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months vs baseline', 'description': 'Reduction of Overall Retinal Nerve Fiber Thickness by Optical Coherence Tomography measured in micron', 'unitOfMeasure': 'micron', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change From Baseline in Visual Field Defects at 9 Months', 'denoms': [{'units': 'Participants', 'counts': [{'value': '19', 'groupId': 'OG000'}, {'value': '17', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'NAION Patients OS-Citicoline Treated', 'description': '19 eyes completed the study, 1 eye drop-out'}, {'id': 'OG001', 'title': 'NAION Patients Untreated', 'description': '17 eyes completed the study, 3 eyes drop-out'}], 'classes': [{'categories': [{'measurements': [{'value': '-15.61', 'spread': '6.43', 'groupId': 'OG000'}, {'value': '-13.02', 'spread': '7.15', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': '9 months vs baseline', 'description': 'improvement of the visual field by static perimetry (increase of the main indexes Mean Deviation measured in dB).', 'unitOfMeasure': 'dB', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'NAION Patients OS-Citicoline Treated', 'description': 'In 20 patients with NAION, OS-Citicoline was administered (500 mg/day) for 6 months followed by three months of suspension (19 completed the study, NC Group)\n\nCiticoline: Citicoline administered in oral solution'}, {'id': 'FG001', 'title': 'NAION Patients Untreated', 'description': 'In 20 patients with NAION no type of treatment was performed during 9 months of observation (17 patients completed the study, NN Group)'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '20'}, {'groupId': 'FG001', 'numSubjects': '20'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '3'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'units': 'eyes', 'counts': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'NAION Patients OS-Citicoline Treated', 'description': 'In 20 patients with NAION, OS-Citicoline will be administered (500 mg/day) for 6 months followed by three months of suspension (NC Group)'}, {'id': 'BG001', 'title': 'NAION Patients Untreated', 'description': 'In 20 patients with NAION, no type of treatment will be performed during 9 months of observation (NN Group)'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '23', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '8', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Italy', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants', 'denomUnitsSelected': 'Participants'}, {'title': 'Number of Participants with NAION diagnosis in the last 6 - 12 months', 'classes': [{'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'denomUnitsSelected': 'Participants'}], 'typeUnitsAnalyzed': 'eyes'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2016-12-20', 'size': 251376, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2018-11-27T05:58', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-02', 'completionDateStruct': {'date': '2018-04-25', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-02-14', 'studyFirstSubmitDate': '2018-11-27', 'resultsFirstSubmitDate': '2018-11-28', 'studyFirstSubmitQcDate': '2018-11-27', 'lastUpdatePostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-02-14', 'studyFirstPostDateStruct': {'date': '2018-11-29', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-11-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change From Baseline in Visual Acuity at 9 Month', 'timeFrame': '9 months vs baseline', 'description': 'Increase of Visual Acuity evaluated by Early Treatment Diabetic Retinopathy Study (ETDRS) charts and measured as a logarithm of the minimum angle of resolution (LogMAR)'}], 'secondaryOutcomes': [{'measure': 'Change From Baseline in Retinal Ganglion Cells Function at 9 Month', 'timeFrame': '9 months vs Baseline', 'description': 'Pattern-Electroretinogram recordings. Increase of P50-N95 amplitude (measured in microvolt)'}, {'measure': 'Change From Baseline in Optic Nerve Function at 9 Months', 'timeFrame': '9 months vs baseline', 'description': 'Visual Evoked Potentials recordings. Shortening of the main parameter P100 Implicit time measured in milliseconds'}, {'measure': 'Change From Baseline in Optic Nerve Morphology at 9 Months', 'timeFrame': '9 months vs baseline', 'description': 'Reduction of Overall Retinal Nerve Fiber Thickness by Optical Coherence Tomography measured in micron'}, {'measure': 'Change From Baseline in Visual Field Defects at 9 Months', 'timeFrame': '9 months vs baseline', 'description': 'improvement of the visual field by static perimetry (increase of the main indexes Mean Deviation measured in dB).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Citicoline', 'Non-arteritic ischemic optic neuropathy', 'Neuroprotection', 'Neuroenhancement'], 'conditions': ['Non-arteritic Ischemic Optic Neuropathy']}, 'referencesModule': {'references': [{'pmid': '28977448', 'type': 'BACKGROUND', 'citation': 'Carelli V, La Morgia C, Ross-Cisneros FN, Sadun AA. Optic neuropathies: the tip of the neurodegeneration iceberg. Hum Mol Genet. 2017 Oct 1;26(R2):R139-R150. doi: 10.1093/hmg/ddx273.'}, {'pmid': '29636122', 'type': 'BACKGROUND', 'citation': 'Cho YS. The role of necroptosis in the treatment of diseases. BMB Rep. 2018 May;51(5):219-224. doi: 10.5483/bmbrep.2018.51.5.074.'}, {'pmid': '16286618', 'type': 'BACKGROUND', 'citation': 'Hayreh SS, Zimmerman B. Visual field abnormalities in nonarteritic anterior ischemic optic neuropathy: their pattern and prevalence at initial examination. Arch Ophthalmol. 2005 Nov;123(11):1554-62. doi: 10.1001/archopht.123.11.1554.'}, {'pmid': '28029908', 'type': 'BACKGROUND', 'citation': 'Patel HR, Margo CE. Pathology of Ischemic Optic Neuropathy. Arch Pathol Lab Med. 2017 Jan;141(1):162-166. doi: 10.5858/arpa.2016-0027-RS.'}, {'pmid': '18557920', 'type': 'BACKGROUND', 'citation': 'Parisi V, Gallinaro G, Ziccardi L, Coppola G. Electrophysiological assessment of visual function in patients with non-arteritic ischaemic optic neuropathy. Eur J Neurol. 2008 Aug;15(8):839-45. doi: 10.1111/j.1468-1331.2008.02200.x. Epub 2008 Jun 28.'}, {'pmid': '28861697', 'type': 'BACKGROUND', 'citation': 'Balducci N, Morara M, Veronese C, Barboni P, Casadei NL, Savini G, Parisi V, Sadun AA, Ciardella A. Optical coherence tomography angiography in acute arteritic and non-arteritic anterior ischemic optic neuropathy. Graefes Arch Clin Exp Ophthalmol. 2017 Nov;255(11):2255-2261. doi: 10.1007/s00417-017-3774-y. Epub 2017 Aug 31.'}, {'pmid': '28320183', 'type': 'BACKGROUND', 'citation': 'Khalilpour S, Latifi S, Behnammanesh G, Majid AMSA, Majid ASA, Tamayol A. Ischemic optic neuropathy as a model of neurodegenerative disorder: A review of pathogenic mechanism of axonal degeneration and the role of neuroprotection. J Neurol Sci. 2017 Apr 15;375:430-441. doi: 10.1016/j.jns.2016.12.044. Epub 2016 Dec 26.'}, {'pmid': '31348806', 'type': 'DERIVED', 'citation': 'Parisi V, Barbano L, Di Renzo A, Coppola G, Ziccardi L. Neuroenhancement and neuroprotection by oral solution citicoline in non-arteritic ischemic optic neuropathy as a model of neurodegeneration: A randomized pilot study. PLoS One. 2019 Jul 26;14(7):e0220435. doi: 10.1371/journal.pone.0220435. eCollection 2019.'}]}, 'descriptionModule': {'briefSummary': "The investigators tested the hypothesis whether the treatment with Citicoline in oral solution (OS-Citicoline) would increase or stabilize visual acuity, retinal ganglion cells (RGCs) function and neural conduction along the visual pathways (neuroenhancement), and/or induce preservation of RGCs fibers' loss (neuroprotection) in an human model of neurodegeneration: non-arteritic ischemic optic neuropathy (NAION).", 'detailedDescription': "The investigators enrolled 40 patients with bilateral or monolateral NAION and 20 age similar controls\n\nTwenty NAION patients received 500 mg/day of OS-Citicoline for a 6-months period followed by 3-months of wash-out (19 patients completed the study, NC Group); 20 NAION patients were not treated (19 patients completed the studyNN Group) from baseline up to 9 months. In all subjects, at baseline, at 6 and 9-months of follow-up: Visual acuity (VA), Pattern Electroretinogram (PERG), Visual Evoked Potentials (VEP), retinal nerve fiber layer thickness (RNFL-T) and Humphrey 24-2 visual field mean deviation (HFA MD) were assessed. Mean differences were statistically evaluated by ANOVA between Groups, and correlations were verified by Pearson's test."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '45 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion criteria:\n\n1. Acute visual reduction episode from NAION occurring for more than 6 months\n2. Typical defects of the visual field evidenced with the Goldmann perimetry or with Humphrey perimetry 30-2\n3. Visual acuity not less than 1/10\n4. Having suspended any potential neuroprotective therapies (e.g., Coenzyme Q10) for at least 6 months.\n\nExclusion criteria:\n\n* Ocular surgery in the 3 months preceding the study, including surgery for cataracts in the previous three months.\n* Cataract or maculopathy\n* Known hypersensitivity to the study product\n* Positive history for diseases of the optic nerve (retrobulbar optic neuropathy, glaucoma) or systemic diseases which could preclude the enrolment in the study according to the investigators' judgement\n* Pregnant or nursing women, or women of potential childbearing age not using adequate contraception.\n* Diabetes, SLE, rheumatoid arthritis, mixed connective tissue disease"}, 'identificationModule': {'nctId': 'NCT03758118', 'briefTitle': 'Citicoline in Non-Arteritic Ischemic Optic Neuropathy', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione G.B. Bietti, IRCCS'}, 'officialTitle': 'Neuroprotection and Neuroenhancement in a Model of Optic Nerve Neurodegeneration (Non Arteritic Ischemic Optic Neuropathy): Study of Morpho-functional Changes Related to Treatment With Citicoline Oral Solution', 'orgStudyIdInfo': {'id': '85356727'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'NAION patients OS-Citicoline treated', 'description': 'In a group of patients with NAION, OS-Citicoline will be administered (500 mg/day) for 6 months followed by three months of suspension', 'interventionNames': ['Dietary Supplement: Citicoline']}, {'type': 'NO_INTERVENTION', 'label': 'NAION patients untreated', 'description': 'In one group of patients with NAION no type of treatment will be performed during 9 months of observation'}], 'interventions': [{'name': 'Citicoline', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Citicoline administered in oral solution', 'armGroupLabels': ['NAION patients OS-Citicoline treated']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00184', 'city': 'Roma', 'country': 'Italy', 'facility': 'Britannico Hospital', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}], 'overallOfficials': [{'name': 'Vincenzo MF Parisi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fondazione Bietti- IRCCS'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione G.B. Bietti, IRCCS', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}