Ignite Creation Date:
2025-12-24 @ 11:40 PM
Ignite Modification Date:
2026-01-01 @ 6:48 PM
Study NCT ID:
NCT04970251
Status:
COMPLETED
Last Update Posted:
2021-07-21
First Post:
2021-06-24
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D015355', 'term': 'Glaucoma, Neovascular'}], 'ancestors': [{'id': 'D005901', 'term': 'Glaucoma'}, {'id': 'D009798', 'term': 'Ocular Hypertension'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D014130', 'term': 'Trabeculectomy'}], 'ancestors': [{'id': 'D018463', 'term': 'Filtering Surgery'}, {'id': 'D013508', 'term': 'Ophthalmologic Surgical Procedures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-07', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-07-11', 'studyFirstSubmitDate': '2021-06-24', 'studyFirstSubmitQcDate': '2021-07-11', 'lastUpdatePostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-07-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Intraocular pressure', 'timeFrame': 'Post-operative on day 1st', 'description': 'Intraocular pressure after trabeculectomy'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Post-operative on day 7th', 'description': 'Intraocular pressure after trabeculectomy'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Post-operative on month 3rd', 'description': 'Intraocular pressure after trabeculectomy'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Post-operative on month 6th', 'description': 'Intraocular pressure after trabeculectomy'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Post-operative on month 12th', 'description': 'Intraocular pressure after trabeculectomy'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Post-operative on month 18th', 'description': 'Intraocular pressure after trabeculectomy'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Post-operative on month 24th', 'description': 'Intraocular pressure after trabeculectomy'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Post-operative on month 30th', 'description': 'Intraocular pressure after trabeculectomy'}, {'measure': 'Intraocular pressure', 'timeFrame': 'Post-operative on month 36th', 'description': 'Intraocular pressure after trabeculectomy'}], 'secondaryOutcomes': [{'measure': 'Visual acuity', 'timeFrame': 'Post-operative on day 1st', 'description': 'Visual acuity of the studied eye'}, {'measure': 'Visual acuity', 'timeFrame': 'Post-operative on day 7th', 'description': 'Visual acuity of the studied eye'}, {'measure': 'Visual acuity', 'timeFrame': 'Post-operative on month 3rd', 'description': 'Visual acuity of the studied eye'}, {'measure': 'Visual acuity', 'timeFrame': 'Post-operative on month 6th', 'description': 'Visual acuity of the studied eye'}, {'measure': 'Visual acuity', 'timeFrame': 'Post-operative on month 12th', 'description': 'Visual acuity of the studied eye'}, {'measure': 'Visual acuity', 'timeFrame': 'Post-operative on month 18th', 'description': 'Visual acuity of the studied eye'}, {'measure': 'Visual acuity', 'timeFrame': 'Post-operative on month 24th', 'description': 'Visual acuity of the studied eye'}, {'measure': 'Visual acuity', 'timeFrame': 'Post-operative on month 30th', 'description': 'Visual acuity of the studied eye'}, {'measure': 'Visual acuity', 'timeFrame': 'Post-operative on month 36th', 'description': 'Visual acuity of the studied eye'}, {'measure': 'Numbers of medication', 'timeFrame': 'Post-operative on month12th', 'description': 'Numbers of anti-glaucoma medications'}, {'measure': 'Numbers of medication', 'timeFrame': 'Post-operative on month 24th', 'description': 'Numbers of anti-glaucoma medications'}, {'measure': 'Numbers of medication', 'timeFrame': 'Post-operative on month 36th', 'description': 'Numbers of anti-glaucoma medications'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Intraocular Pressure', 'Neovascular Glaucoma', 'Vascular Endothelial Growth Factor Overexpression', 'Glaucoma Secondary to Eye Inflammation']}, 'referencesModule': {'references': [{'pmid': '25812531', 'type': 'RESULT', 'citation': 'Kitnarong N, Sriyakul C, Chinwattanakul S. A Prospective Study to Evaluate Intravitreous Ranibizumab as Adjunctive Treatment for Trabeculectomy in Neovascular Glaucoma. Ophthalmol Ther. 2015 Jun;4(1):33-41. doi: 10.1007/s40123-015-0033-3. Epub 2015 Mar 27.'}, {'pmid': '18425438', 'type': 'RESULT', 'citation': 'Kitnarong N, Chindasub P, Metheetrairut A. Surgical outcome of intravitreal bevacizumab and filtration surgery in neovascular glaucoma. Adv Ther. 2008 May;25(5):438-43. doi: 10.1007/s12325-008-0047-5.'}, {'pmid': '25580888', 'type': 'RESULT', 'citation': 'Kobayashi S, Inoue M, Yamane S, Sakamaki K, Arakawa A, Kadonosono K. Long-term Outcomes After Preoperative Intravitreal Injection of Bevacizumab Before Trabeculectomy for Neovascular Glaucoma. J Glaucoma. 2016 Mar;25(3):281-4. doi: 10.1097/IJG.0000000000000211.'}]}, 'descriptionModule': {'briefSummary': 'Purpose: To investigate intravitreal aflibercept (IVA) injection as an adjunctive treatment to trabeculectomy with mitomycin C (TMC) and panretinal photocoagulation (PRP) for neovascular glaucoma (NVG).\n\nSetting: Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand Study design: Prospective interventional case series Methods: PRP and IVA (2 mg/0.05 ml) injection were given, and TMC was performed within 2 weeks after IVA. Additional PRP, laser suture lysis, subconjunctival 5-fluorouracil injection, and bleb needling were performed after TMC if indicated. Best-collected visual acuity (BCVA), intraocular pressure (IOP), surgical complications, and number of anti-glaucoma medications were collected.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Consecutive patients with neovascular glaucoma who presented at the Department of Ophthalmology, Faculty of Medicine Siriraj Hospital, Mahidol University, Bangkok, Thailand during November 2018 to October 2019.\n* Aged more than 18 year-old\n\nExclusion Criteria:\n\n* Patients who received any anti-vascular endothelial growth factor treatment before participation'}, 'identificationModule': {'nctId': 'NCT04970251', 'briefTitle': 'Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular Glaucoma', 'organization': {'class': 'OTHER', 'fullName': 'Siriraj Hospital'}, 'officialTitle': 'Aflibercept as Adjunctive Treatment for Filtration Surgery in Neovascular', 'orgStudyIdInfo': {'id': 'Si726/2018'}}, 'armsInterventionsModule': {'interventions': [{'name': 'Aflibercept Ophthalmic', 'type': 'DRUG', 'otherNames': ['trabeculectomy', 'Panretinal photocoagulation'], 'description': 'Panretinal photocoagulation and intravitreal aflibercept (2 mg/0.05 ml) injection were given, and trabeculectomy with mitomycin C was performed within 2 weeks after intravitreal aflibercept injection.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '10700', 'city': 'Bangkoknoi', 'state': 'Bangkok', 'country': 'Thailand', 'facility': 'Naris Kitnarong'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'Centers who collect the data of neovascular Glaucoma patients who underwent intravitreal aflibercept injection, pan retinal photocoagulation and trabeculectomy with mitomycin C.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Siriraj Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate professor', 'investigatorFullName': 'Naris Kitnarong', 'investigatorAffiliation': 'Siriraj Hospital'}}}}