Ignite Creation Date:
2025-12-24 @ 4:21 PM
Ignite Modification Date:
2026-01-22 @ 11:20 AM
Study NCT ID:
NCT03054766
Status:
COMPLETED
Last Update Posted:
2022-12-28
First Post:
2017-02-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 80}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-02-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-12', 'completionDateStruct': {'date': '2019-01-28', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-12-25', 'studyFirstSubmitDate': '2017-02-05', 'studyFirstSubmitQcDate': '2017-02-13', 'lastUpdatePostDateStruct': {'date': '2022-12-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-16', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity changes', 'timeFrame': 'one year', 'description': 'comparing the changes of visual acuity between the two groups'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Laser Photocoagulation', 'Ranibizumab', 'Branch Retinal Vein Occlusion', 'Vascular Endothecial Growth Factor'], 'conditions': ['Branch Retinal Vein Occlusion', 'Ranibizumab', 'Laser Photocoagulation']}, 'referencesModule': {'references': [{'pmid': '20601660', 'type': 'BACKGROUND', 'citation': 'Pece A, Isola V, Piermarocchi S, Calori G. Efficacy and safety of anti-vascular endothelial growth factor (VEGF) therapy with intravitreal ranibizumab (Lucentis) for naive retinal vein occlusion: 1-year follow-up. Br J Ophthalmol. 2011 Jan;95(1):56-68. doi: 10.1136/bjo.2009.174060. Epub 2010 Jul 3.'}, {'pmid': '32560639', 'type': 'DERIVED', 'citation': 'Song S, Yu X, Zhang P, Gu X, Dai H. Combination of Ranibizumab with macular laser for macular edema secondary to branch retinal vein occlusion: one-year results from a randomized controlled double-blind trial. BMC Ophthalmol. 2020 Jun 19;20(1):241. doi: 10.1186/s12886-020-01498-7.'}]}, 'descriptionModule': {'briefSummary': 'To investigate the efficacy of laser photocoagulation combined with ranibizumab intravitreal injection in macular edema (ME) secondary to branch retinal vein occlusion (BRVO) in long term.', 'detailedDescription': 'To investigate the efficacy of ranibizumab intravitreal injections-driven by achieving vision acuity stabilization compared to combination with laser photocoagulation in Chinese patients with visual impairment in ME due to BRVO.\n\nThe result of the trial will be used to support new therapy in the BRVO in China.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Written informed consent\n2. Male or female Chinese patients ≥ 18 years of age with BRVO\n3. Visual impairment due to ME secondary to BRVO in at least one eye with BCVA score between 73 and 24 and at least 24 letters in the other eye\n\nExclusion Criteria:\n\n1. Pregnant or nursing (lactating) women or women of child-bearing potential without using effective contraception\n2. Stroke or myocardial infarction less than 3 months prior to screening visit\n3. Renal failure or creatinine levels \\> 2.0 mg/dl\n4. Uncontrolled hypertension\n5. Active ocular infection or intraocular inflammation in any eye\n6. Neovascularization of the iris or neovascular glaucoma in any eye\n7. History of uveitis or vitreomacular traction in any eye\n8. Treatment with any anti-angiogenic drugs within 3 months prior to baseline visit in any eye\n9. Glaucoma or intraocular pressure (IOP) ≥ 24 mmHg in study eye\n10. Active proliferative diabetic retinopathy in study eye\n11. Use of other investigational drugs within 30 days and systemic vascular endothecial growth factor (VEGF) antagonism drugs within 6 months prior to baseline visit\n12. Prior laser photocoagulation or intraocular procedure within 3 months prior to baseline in study eye\n13. History of intravitreal corticosteroid treatment in phakic study eye, and in aphakic or pseudophakic within 3 months prior to screening\n14. History of vitrectomy in study eye\n15. Other protocol defined inclusion /exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT03054766', 'briefTitle': 'Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for ME Secondary to BRVO', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Beijing Hospital'}, 'officialTitle': 'The Randomized Double-blind Controlled Clinical Trial of Combination of Intravitreal Ranibizumab With or Without Macular Laser Photocoagulation for Macular Edema Secondary to Branch Retinal Vein Occlusion', 'orgStudyIdInfo': {'id': '121-2016001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ranibizumab only', 'description': 'Sham macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization\n\nInterventions :Ranibizumab injection Interventions :Sham macular laser', 'interventionNames': ['Drug: Ranibizumab']}, {'type': 'EXPERIMENTAL', 'label': 'Ranibizumab combined macular laser', 'description': 'Macular laser photocoagulation treatment after third ranibizumab injection with PRN intravitreal injections of ranibizumab 0.5 mg guided by BCVA stabilization\n\nInterventions :Ranibizumab injection Interventions :Macular laser photocoagulation', 'interventionNames': ['Procedure: Ranibizumab combined macular laser', 'Drug: Ranibizumab']}], 'interventions': [{'name': 'Ranibizumab combined macular laser', 'type': 'PROCEDURE', 'description': 'subjects in one group receive both macular laser photocoagulation and ranibizumab injections but ones in the other group just received ranibizumab injection.', 'armGroupLabels': ['Ranibizumab combined macular laser']}, {'name': 'Ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis'], 'description': 'all subjections received 3+PRN ranibizumab injections by BCVA stabilization', 'armGroupLabels': ['Ranibizumab combined macular laser', 'Ranibizumab only']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100730', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Beijing Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'Xiao-bing Yu, M.D', 'role': 'STUDY_CHAIR', 'affiliation': 'Beijing Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'share the results of the study,and one can send message to yuxiaobing@sina.come for information'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Beijing Hospital', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D', 'investigatorFullName': 'Yu Xiaobing', 'investigatorAffiliation': 'Beijing Hospital'}}}}