Ignite Creation Date:
2025-12-25 @ 3:21 AM
Ignite Modification Date:
2025-12-26 @ 1:59 AM
Study NCT ID:
NCT06078605
Status:
UNKNOWN
Last Update Posted:
2023-10-12
First Post:
2023-02-13
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-09-16', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-10', 'completionDateStruct': {'date': '2024-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-10-09', 'studyFirstSubmitDate': '2023-02-13', 'studyFirstSubmitQcDate': '2023-10-09', 'lastUpdatePostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-10-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)', 'timeFrame': 'Baseline,12weeks', 'description': 'Change of PhNR\\_min(photopic negative response) as measured by Electroretinogram after 12 weeks'}], 'secondaryOutcomes': [{'measure': 'Change of PhNR_min(photopic negative response) as measured by Electroretinogram (intra-group)', 'timeFrame': 'Baseline, 6, 12, 18, 24weeks', 'description': 'Change of PhNR\\_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks'}, {'measure': 'Change of PhNR_min(photopic negative response) as measured by Electroretinogram (Group1 VS Group2)', 'timeFrame': 'Baseline, 6, 12, 18, 24weeks', 'description': 'Change of PhNR\\_min(photopic negative response) as measured by Electroretinogram after 6, 12, 18 and 24 weeks'}, {'measure': 'Change of mean deviation as measured by Visual Fields (intra-group)', 'timeFrame': 'Baseline, 12weeks, 24weeks', 'description': 'Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks'}, {'measure': 'Change of mean deviation as measured by Visual Fields (Group1 VS Group2)', 'timeFrame': 'Baseline, 12weeks, 24weeks', 'description': 'Change of mean deviation as measured by Visual Fields after 12 weeks and 24 weeks'}, {'measure': 'Change of Pointwise sensitivity as measured by Visual Fields (Group1 VS Group2)', 'timeFrame': 'Baseline, 12weeks, 24weeks', 'description': 'Change of Pointwise sensitivity in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total/pattern deviation'}, {'measure': 'Change of visual field sensitivity number of locations', 'timeFrame': 'Baseline, 12weeks, 24weeks', 'description': 'Change of visual field sensitivity number of locations in glaucomatous eyes as measured by Visual Fields after 12 and 24 weeks: total, pattern deviation'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Nicotinamide', 'inner retinal function', 'retinal ganglion cell functions', 'Glaucoma', 'Vitamin B3', 'NAM', 'NRG1'], 'conditions': ['Glaucoma']}, 'referencesModule': {'references': [{'pmid': '41167798', 'type': 'DERIVED', 'citation': 'Ha A, Kim YK, Lee CK, Williams PA, Morgan JE, Shin YI, Kim E, Kim M, Rho S. Effects of nicotinamide supplementation in normal-tension glaucoma: a crossover placebo-controlled randomised clinical trial. Br J Ophthalmol. 2025 Oct 30:bjo-2025-328096. doi: 10.1136/bjo-2025-328096. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study', 'detailedDescription': 'Not provided'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '19 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Adult(Male or Female) over 19 years who were diagnosed with glaucoma.\n2. In the case of participants receiving glaucoma treatment drugs, the investigator judges that the intraocular pressure remains constant for at least 1 year.\n3. Intraocular pressure (IOP) \\>/= 8mmHg and \\< 18mmHg in each eye using Goldmann applanation tonometry prior to the screening visit\n4. Adult participants diagnosed and treated for early-moderate glaucoma (VF mean deviation(MD) ≥-12 dB)\n5. Have performed a reliable visual field in the last year, with \\<33% fixation losses, false positives and false negatives.\n6. Written consent voluntarily to participate in this clinical trial.\n\nExclusion Criteria:\n\n1. Patients with congenital glaucoma and secondary glaucoma caused by steroid drugs, etc.\n2. BCVA (best-corrected visual acuity) Snellen equivalent of Snellen 20/80(logMar 0.25) or less.\n3. Patients who have medical history of ocular inflammation\n4. Patients with any ocular/systemic conditions that may affect electroretinogram parameter, or with visual field defects(Ischemic optic neuropathy, Proliferative diabetic retinopathy, Macular degeneration etc.)\n5. Patients who have plans to intraocular surgery within the clinical trial period.\n6. Patients with a history of significant ocular trauma within 6 months prior to the screening visit\n7. Pregnant or lactating women.\n8. A person who disagrees to contraception during a clinical trial period.\n9. Patients with a history of malignancy within 5 years prior to the screening visit.\n10. Patients that other researchers are determined inadequately.'}, 'identificationModule': {'nctId': 'NCT06078605', 'briefTitle': 'Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients', 'organization': {'class': 'OTHER', 'fullName': 'CHA University'}, 'officialTitle': 'Efficacy of Nicotinamide on Retinal Ganglion Cell Functions in Glaucoma Patients : Clinical Trial, Cross-over Design, Double-blind, Placebo-control, Randomized, Single-center Study', 'orgStudyIdInfo': {'id': 'NRG1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Nicotinamide(Mitovita)', 'description': 'Group2 Baseline-6week: (Mitovita: 1.0 g/day, QD) 6-12week: (Mitovita: 2.0 g/day, BID) Crossover 12-18week: (Placebo: 1.0 g/day, QD) 18-24week: (Placebo: 2.0 g/day, BID)', 'interventionNames': ['Other: Nicotinamide(Mitovita)']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Group1 Baseline-6week: (Placebo: 1.0 g/day, QD) 6-12week: (Placebo: 2.0 g/day, BID) Crossover 12-18week: (Mitovita: 1.0 g/day, QD) 18-24week: (Mitovita: 2.0 g/day, BID)', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Nicotinamide(Mitovita)', 'type': 'OTHER', 'description': 'Nicotinamide(VitaminB3)', 'armGroupLabels': ['Nicotinamide(Mitovita)']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Placebo', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '13497', 'city': 'Seongnam', 'state': 'Bundang-gu', 'status': 'RECRUITING', 'country': 'South Korea', 'contacts': [{'name': 'Seungsoo Rho, MD, PhD', 'role': 'CONTACT', 'email': 'harryrho@gmail.com', 'phone': '+82-10-9260-3173'}], 'facility': 'CHA University Bundang Medical Center', 'geoPoint': {'lat': 35.54127, 'lon': 127.39683}}], 'centralContacts': [{'name': 'Seungsoo Rho, MD, PhD', 'role': 'CONTACT', 'email': 'harryrho@gmail.com', 'phone': '82-10-9260-3173'}], 'overallOfficials': [{'name': 'Seungsoo Rho, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'CHA Bundang Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CHA University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Hanlim Pharm. Co., Ltd.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}