Ignite Creation Date:
2025-12-25 @ 12:56 AM
Ignite Modification Date:
2025-12-26 @ 1:29 PM
Study NCT ID:
NCT00210067
Status:
COMPLETED
Last Update Posted:
2015-10-09
First Post:
2005-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study in Subjects With Retinal Detachment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}], 'ancestors': [{'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C465279', 'term': 'denufosol tetrasodium'}, {'id': 'D058449', 'term': 'Intravitreal Injections'}], 'ancestors': [{'id': 'D056965', 'term': 'Injections, Intraocular'}, {'id': 'D007267', 'term': 'Injections'}, {'id': 'D004333', 'term': 'Drug Administration Routes'}, {'id': 'D004358', 'term': 'Drug Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2001-05'}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-10-08', 'studyFirstSubmitDate': '2005-09-13', 'studyFirstSubmitQcDate': '2005-09-13', 'lastUpdatePostDateStruct': {'date': '2015-10-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-09-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2002-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'tolerability'}], 'secondaryOutcomes': [{'measure': 'pharmacological activity'}]}, 'conditionsModule': {'conditions': ['Retinal Detachment']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to access the tolerability of INS37217 Intravitreal Injection when administered intravitreally in subjects with macula-on or macula-off rhegmatogenous retinal detachment (RRD).'}, 'eligibilityModule': {'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have macula-on or macula-off rhegmatogenous retinal detachment\n* are eligible for pneumatic retinopexy, with identifiable retinal breaks\n* are phakic or pseudo-phakic\n\nExclusion Criteria:\n\n* have detachments not of a rhegmatogenous nature\n* currently have blood in the vitreous, corneal opacity, or other conditions which limit the view of peripheral retina\n* have evidence of intraocular inflammation (uveitis)\n* have a history of current condition of uncontrollable, elevated IOP or open-angle glaucoma\n* have breaks not conducive to a single procedure of pneumatic retinopexy treatment\n* have proliferative vitreoretinopathy of type C or D\n* have previously had a vitrectomy or require one\n* have previously had a scleral buckle procedure'}, 'identificationModule': {'nctId': 'NCT00210067', 'briefTitle': 'A Study in Subjects With Retinal Detachment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Double-Masked, Randomized, Dose-Ranging Study of a Single Intravitreal (IVT) Injection of INS37217 Intravitreal Injection in Subjects With Retinal Detachment', 'orgStudyIdInfo': {'id': '06-101'}}, 'armsInterventionsModule': {'interventions': [{'name': 'denufosol tetrasodium (INS37217) Intravitreal Injection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Amy Schaberg, BSN', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}