Ignite Creation Date:
2025-12-24 @ 5:07 PM
Ignite Modification Date:
2025-12-26 @ 7:42 AM
Study NCT ID:
NCT05474950
Status:
UNKNOWN
Last Update Posted:
2023-04-19
First Post:
2022-07-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Minocycline Treatment for Cystoid Macular Edema
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'C562573', 'term': 'cyclopia sequence'}, {'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008911', 'term': 'Minocycline'}], 'ancestors': [{'id': 'D013754', 'term': 'Tetracyclines'}, {'id': 'D009279', 'term': 'Naphthacenes'}, {'id': 'D011084', 'term': 'Polycyclic Aromatic Hydrocarbons'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2025-06-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-16', 'studyFirstSubmitDate': '2022-07-23', 'studyFirstSubmitQcDate': '2022-07-23', 'lastUpdatePostDateStruct': {'date': '2023-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change of cystoid macular edema', 'timeFrame': 'At 6 months', 'description': 'Change of CME measured by Optical coherence tomography (OCT)'}], 'secondaryOutcomes': [{'measure': 'Change of best corrected visual acuity (BCVA)', 'timeFrame': 'At 6 months', 'description': 'Change of BCVA measured by the Early Treatment Diabetic Retinopathy Study'}, {'measure': 'Change of macular sensitivity', 'timeFrame': 'At 6 months', 'description': 'Change of BCVA measured by Macular Integrity Assessment (MAIA)'}, {'measure': 'Change of retinal vascular leakage', 'timeFrame': 'At 6 months', 'description': 'Change of retinal vascular leakage measured by Fundus fluorescein angiography (FFA) or indocyanine green angiography (ICGA)'}, {'measure': 'Change of macular vessel', 'timeFrame': 'At 6 months', 'description': 'Change of macular vessel measured by optical coherence tomography angiography (OCTA)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Minocycline', 'Cystoid Macular Edema']}, 'referencesModule': {'references': [{'pmid': '36912792', 'type': 'DERIVED', 'citation': 'Romano F, Lamanna F, Gabrielle PH, Teo KYC, Battaglia Parodi M, Iacono P, Fraser-Bell S, Cornish EE, Nassisi M, Viola F, Agarwal A, Samanta A, Chhablani J, Staurenghi G, Invernizzi A. Update on Retinal Vein Occlusion. Asia Pac J Ophthalmol (Phila). 2023 Mar-Apr 01;12(2):196-210. doi: 10.1097/APO.0000000000000598. Epub 2023 Feb 14.'}]}, 'descriptionModule': {'briefSummary': 'Cystoid macular edema (CME) is one of sight-threatening, immune-related ocular diseases. The efficacy of current treatments for CME (anti-VEGF, glucocorticoids and other agents) are limiting. Minocycline, acting as a broad-spectrum antibiotic, is among tetracycline family and recently, its immunomodulatory and anti-apoptosis function has been replied to several immune diseases and degenerative diseases. This study aims to explore the efficacy and safety of minocycline for CME.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant diagnosed with CME.\n* Participant aged from 18-60 years old.\n* Participant that signed the informed consent document and is able to complete the following visits.\n\nExclusion Criteria:\n\n* Participant is allergy to minocycline or tetracyclines.\n* Participant has no contraindications of minocycline or tetracyclines.\n* Participant has an abnormal function of liver, heart, kidney and thyroid.\n* Female that is pregnant, breast-feeding or planning to become pregnant.\n* Participant that is currently using other medications.'}, 'identificationModule': {'nctId': 'NCT05474950', 'acronym': 'MINOCME', 'briefTitle': 'Minocycline Treatment for Cystoid Macular Edema', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Efficacy and Safety of the Treatment of Minocycline for Cystoid Macular Edema', 'orgStudyIdInfo': {'id': 'MINOCME'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'minocycline', 'interventionNames': ['Drug: minocycline']}], 'interventions': [{'name': 'minocycline', 'type': 'DRUG', 'description': 'minocycline capsule (100mg) per day orally', 'armGroupLabels': ['minocycline']}]}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Dan Liang', 'role': 'CONTACT', 'email': 'liangdan@gzzoc.com', 'phone': '（86）-87330402'}, {'name': 'Dan Liang', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yuxi Chen', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Zhongshan Ophthalmic Center', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dan Liang, PhD', 'investigatorFullName': 'Dan Liang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}