Ignite Creation Date:
2025-12-25 @ 4:57 AM
Ignite Modification Date:
2026-01-16 @ 9:59 AM
Study NCT ID:
NCT01662518
Status:
COMPLETED
Last Update Posted:
2017-02-01
First Post:
2012-08-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'intervention group: 25-gauge biodegradable implant containing 350 μg of dexamethasone (DDS-25) for the treatment of decreased vision due to macular edema associated with central or branch retinal vein occlusion.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-01-30', 'studyFirstSubmitDate': '2012-08-08', 'studyFirstSubmitQcDate': '2012-08-09', 'lastUpdatePostDateStruct': {'date': '2017-02-01', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-08-10', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best Corrected Visual Acuity (BCVA)', 'timeFrame': 'Day 0 - Day 180'}], 'secondaryOutcomes': [{'measure': 'Change in central foveal thickness at 48 weeks', 'timeFrame': '1 day to 48 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Macular Edema', 'Retinal Vein Occlusion']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'http://www.ncbi.nlm.nih.gov/pubmed/27632583', 'label': 'SAFETY AND FEASIBILITY OF A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT OF DEXAMETHASONE FOR TREATMENT OF MACULAR EDEMA ASSOCIATED WITH RETINAL VEIN OCCLUSION: A PHASE I CLINICAL TRIAL.'}]}, 'descriptionModule': {'briefSummary': 'This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone (DDS-25) for the treatment of macular edema associated with retinal vein occlusion.', 'detailedDescription': 'Evaluate the effects on visual acuity, electroretinography, fluorescein angiography and optical coherence tomography in 10 patients with macular edema associated with retinal vein occlusion undergoing intravitreal injection of implant of dexamethasone (DDS-25).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older with macular edema resulting from retinal vein occlusion\n* Decrease in visual acuity in at least one eye as a result of macular edema (20/50 or worse)\n* Visual acuity in other eye no worse than 20/200\n\nExclusion Criteria:\n\n* Known anticipated need for ocular surgery within next 12 months\n* History of glaucoma or current high eye pressure requiring more than 1 medication\n* Diabetic retinopathy\n* Uncontrolled systemic disease\n* Known steroid-responder\n* Use of systemic steroids\n* Use of warfarin/heparin'}, 'identificationModule': {'nctId': 'NCT01662518', 'acronym': 'DDS-25', 'briefTitle': 'DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)', 'organization': {'class': 'OTHER', 'fullName': 'Centro de Pesquisa Rubens Siqueira'}, 'officialTitle': 'A Safety and Efficacy Study to Assess DDS-25 Gauge in Patients With Macular Edema Secondary to Retinal Vein Occlusion (RVO)', 'orgStudyIdInfo': {'id': 'Bramets-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'DDS-25', 'description': 'Intravitreal injection of DDS-25(Dexamethasone drug delivery system )', 'interventionNames': ['Device: Dexamethasone drug delivery system (DDS-25)']}], 'interventions': [{'name': 'Dexamethasone drug delivery system (DDS-25)', 'type': 'DEVICE', 'description': '350 mg Dexamethasone posterior segment drug delivery system (DDS-25) injection into the vitreous cavity at baseline', 'armGroupLabels': ['DDS-25']}]}, 'contactsLocationsModule': {'locations': [{'zip': '15010-100', 'city': 'São José do Rio Preto', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'Centro de Pesquisa Rubens Siqueira', 'geoPoint': {'lat': -20.81972, 'lon': -49.37944}}], 'overallOfficials': [{'name': 'Rubens C Siqueira, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centro de Pesquisa Rubens Siqueira'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Retin Cases Brief Rep. 2016 Sep 14. \\[Epub ahead of print\\] SAFETY AND FEASIBILITY OF A NOVEL 25-GAUGE BIODEGRADABLE IMPLANT OF DEXAMETHASONE FOR TREATMENT OF MACULAR EDEMA ASSOCIATED WITH RETINAL VEIN OCCLUSION: A PHASE I CLINICAL TRIAL.\n\nCunha RB1, Siqueira RC, Messias A, Scott IU, Fialho SL, Cunha-Junior AD, Jorge R.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centro de Pesquisa Rubens Siqueira', 'class': 'OTHER'}, 'collaborators': [{'name': 'University of Sao Paulo', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD,PhD - Principal Investigator', 'investigatorFullName': 'Rubens Camargo Siqueira', 'investigatorAffiliation': 'Centro de Pesquisa Rubens Siqueira'}}}}