Ignite Creation Date:
2025-12-24 @ 5:33 PM
Ignite Modification Date:
2025-12-27 @ 12:47 PM
Study NCT ID:
NCT06038968
Status:
COMPLETED
Last Update Posted:
2024-02-05
First Post:
2023-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003930', 'term': 'Diabetic Retinopathy'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D003925', 'term': 'Diabetic Angiopathies'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D048909', 'term': 'Diabetes Complications'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008727', 'term': 'Methotrexate'}], 'ancestors': [{'id': 'D000630', 'term': 'Aminopterin'}, {'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-09', 'completionDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-02-02', 'studyFirstSubmitDate': '2023-09-08', 'studyFirstSubmitQcDate': '2023-09-08', 'lastUpdatePostDateStruct': {'date': '2024-02-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-09-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-11-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'assess retinal layers by optical coherence tomography', 'timeFrame': 'one month after pars plana vitrectomy and one month after silicone oil evacuation', 'description': 'presence of epiretinal membrane, cystic changes in retina, central macular thickens'}, {'measure': 'assess functional outcomes by multifocal electroretinogram', 'timeFrame': 'one month after pars plana vitrectomy and one month after silicone oil evacuation', 'description': 'latency and amplitude of main P wave'}], 'secondaryOutcomes': [{'measure': 'Anterior segment slit lamp biomicroscopic examination', 'timeFrame': 'one month after pars plana vitrectomy', 'description': 'assess anterior segment inflammation as iritis or posterior synechia'}, {'measure': 'visual acuity', 'timeFrame': 'one month after pars plana vitrectomy and one month after silicone oil evacuation', 'description': 'by logMAR (Logarithm of the Minimum Angle of Resolution)'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Methotrexate', 'proliferative diabetic retinopathy'], 'conditions': ['Diabetic Retinopathy', 'Vitreomacular Traction']}, 'referencesModule': {'references': [{'pmid': '20139916', 'type': 'BACKGROUND', 'citation': 'Newman DK. Surgical management of the late complications of proliferative diabetic retinopathy. Eye (Lond). 2010 Mar;24(3):441-9. doi: 10.1038/eye.2009.325. Epub 2010 Feb 5.'}, {'pmid': '24613889', 'type': 'BACKGROUND', 'citation': 'Meleth AD, Carvounis PE. Outcomes of vitrectomy for tractional retinal detachment in diabetic retinopathy. Int Ophthalmol Clin. 2014 Spring;54(2):127-39. doi: 10.1097/IIO.0000000000000021. No abstract available.'}, {'pmid': '23028203', 'type': 'BACKGROUND', 'citation': 'Gologorsky D, Thanos A, Vavvas D. Therapeutic interventions against inflammatory and angiogenic mediators in proliferative diabetic retinopathy. Mediators Inflamm. 2012;2012:629452. doi: 10.1155/2012/629452. Epub 2012 Sep 17.'}, {'pmid': '22409294', 'type': 'BACKGROUND', 'citation': 'Zhou J, Wang S, Xia X. Role of intravitreal inflammatory cytokines and angiogenic factors in proliferative diabetic retinopathy. Curr Eye Res. 2012 May;37(5):416-20. doi: 10.3109/02713683.2012.661114. Epub 2012 Mar 12.'}, {'pmid': '21556354', 'type': 'BACKGROUND', 'citation': 'Ricker LJ, Kijlstra A, Kessels AG, de Jager W, Liem AT, Hendrikse F, La Heij EC. Interleukin and growth factor levels in subretinal fluid in rhegmatogenous retinal detachment: a case-control study. PLoS One. 2011 Apr 27;6(4):e19141. doi: 10.1371/journal.pone.0019141.'}, {'pmid': '11382642', 'type': 'BACKGROUND', 'citation': 'Samson CM, Waheed N, Baltatzis S, Foster CS. Methotrexate therapy for chronic noninfectious uveitis: analysis of a case series of 160 patients. Ophthalmology. 2001 Jun;108(6):1134-9. doi: 10.1016/s0161-6420(01)00576-0.'}, {'pmid': '12208721', 'type': 'BACKGROUND', 'citation': "Smith JR, Rosenbaum JT, Wilson DJ, Doolittle ND, Siegal T, Neuwelt EA, Pe'er J. Role of intravitreal methotrexate in the management of primary central nervous system lymphoma with ocular involvement. Ophthalmology. 2002 Sep;109(9):1709-16. doi: 10.1016/s0161-6420(02)01125-9."}, {'pmid': '28777835', 'type': 'BACKGROUND', 'citation': 'Amarnani D, Machuca-Parra AI, Wong LL, Marko CK, Stefater JA, Stryjewski TP, Eliott D, Arboleda-Velasquez JF, Kim LA. Effect of Methotrexate on an In Vitro Patient-Derived Model of Proliferative Vitreoretinopathy. Invest Ophthalmol Vis Sci. 2017 Aug 1;58(10):3940-3949. doi: 10.1167/iovs.16-20912.'}]}, 'descriptionModule': {'briefSummary': 'The goal of this interventional clinical trial is to assess anatomical and functional outcomes of methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery in patients with advanced proliferative diabetic retinopathy.\n\nThe main questions it aims to answer are:\n\n1. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery decrease the post operative vitreoretinal proliferation after vitrectomy in patients with advanced proliferative diabetic retinopathy?\n2. Does methotrexate use in irrigating fluid during parsplana vitrectomy combined with intrasilicone injection at end of surgery improve post operative functional outcome after vitrectomy in patients with advanced proliferative diabetic retinopathy?\n\nResearchers will compare the anatomical and functional outcomes after vitrectomy in patients with advanced proliferative diabetic retinopathy without using methotrexate.', 'detailedDescription': 'Tractional macular detachment (TMD) or macula threatening tractional retinal detachment (TRD) and combined tractional-rhegmatogenous retinal detachment (TRD/RRD) are considered as important indications for vitreoretinal intervention.\n\nAlthough a growing number of eyes with TMD and TRD/RRD are successfully treated with a single procedure, retinal re-detachment associated with fibrovascular proliferation or proliferative vitreoretinopathy (PVR) is still a major cause of failure of the surgery.\n\nPrevious studies have shown increased expression of inflammatory cytokines and growth factors in both proliferative diabetic retinopathy (PDR) and PVR.\n\nMethotrexate (MTX) is an anti-neoplastic and anti-inflammatory agent used to treat a variety of malignancies and rheumatologic diseases.\n\nIn ophthalmology, systemic and intraocular MTX has been successfully used for indeterminate uveitis, sarcoid uveitis and intraocular lymphoma.\n\nMTX has been recently found to inhibit PVR by stopping cellular proliferation and promoting organized apoptosis. MTX has also been found to be effective in lowering the incidence of PVR when used as an adjunct in irrigation fluid during vitrectomy for retinal detachment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Patients with diabetic tractional macular detachment or combined tractional- rhegmatogenous retinal detachment\n\nExclusion Criteria:\n\n* Previous vitreoretinal surgery.\n* Pregnant or lactating female.\n* Co-existing pathology that might induce PVR such as penetrating ocular trauma or uveitis, co-existing congenital anomalies or hereditary vitreoretinopathies'}, 'identificationModule': {'nctId': 'NCT06038968', 'briefTitle': 'Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy', 'organization': {'class': 'OTHER', 'fullName': 'Minia University'}, 'officialTitle': 'Anatomical and Functional Outcomes of Use of Methotrexate Infusion and Intrasilicone Injection During Diabetic Vitrectomy', 'orgStudyIdInfo': {'id': 'MTX DM vitrectomy'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Methotrexate group', 'description': 'methotrexate group will receive 40 mg of MTX in 500 ml of irrigation fluid during vitrectomy and 250 ug intra-silicone oil injection at the end of vitrectomy', 'interventionNames': ['Drug: Methotrexate 25 MG/ML', 'Procedure: parsplana vitrectomy']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Control group', 'description': 'control group will not receive MTX in irrigation fluid during vitrectomy nor intra-silicone at the end of vitrectomy', 'interventionNames': ['Procedure: parsplana vitrectomy']}], 'interventions': [{'name': 'Methotrexate 25 MG/ML', 'type': 'DRUG', 'otherNames': ['Methotrexate Mylan 50 mg/2 mL'], 'description': 'Methotrexate is a folate derivative that inhibits several enzymes responsible for nucleotide synthesis. This inhibition leads to suppression of inflammation as well as prevention of cell division.', 'armGroupLabels': ['Methotrexate group']}, {'name': 'parsplana vitrectomy', 'type': 'PROCEDURE', 'description': 'Pars plana vitrectomy (PPV) is a technique in vitreoretinal surgery that enables access to the posterior segment for treating tractional retinal detachment in advanced proliferative diabetic retinopathy, in a controlled, closed system.', 'armGroupLabels': ['Control group', 'Methotrexate group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '61519', 'city': 'Minya', 'state': 'Minya Governorate', 'country': 'Egypt', 'facility': 'ophthalmology department, Minia university hospital', 'geoPoint': {'lat': 28.09193, 'lon': 30.75813}}], 'overallOfficials': [{'name': 'Rabie MM Hasanin, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'ophthalmology department, faculty of medicine, Minia university hospital'}, {'name': 'Khaled MS morad, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ophthalmology department, faculty of medicine, Minia university hospital'}, {'name': 'Ahmed MA Shawkat, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ophthalmology department, faculty of medicine, Minia university hospital'}, {'name': 'Mohamed Tarek AM Mostafa, Ass. Prof.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'ophthalmology department, faculty of medicine, Minia university hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'email the main investigator for requested data'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Minia University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'assistant lecturer, ophthalmology department, faculty of medicine', 'investigatorFullName': 'Abdallah Mohsen Mohamed Safwat', 'investigatorAffiliation': 'Minia University'}}}}