Ignite Creation Date:
2025-12-25 @ 12:37 AM
Ignite Modification Date:
2025-12-27 @ 11:31 AM
Study NCT ID:
NCT00083967
Status:
TERMINATED
Last Update Posted:
2015-04-10
First Post:
2004-06-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D012167', 'term': 'Retinal Perforations'}], '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': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 23}}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2004-06'}, 'statusVerifiedDate': '2015-04', 'completionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-04-09', 'studyFirstSubmitDate': '2004-06-03', 'studyFirstSubmitQcDate': '2004-06-04', 'lastUpdatePostDateStruct': {'date': '2015-04-10', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2004-06-07', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2006-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Compare safety and tolerability of single and/or multiple intravitreal injections of three dose levels of denufosol vs. placebo'}, {'measure': 'Compare efficacy of denufosol vs. placebo as a treatment for detachment of the retina in RRD subjects'}], 'secondaryOutcomes': [{'measure': 'Identify one or more dose levels of denufosol as safe and potentially effective to warrant study in Phase 3'}, {'measure': 'Evaluate utility of 3D B-scan ultrasound technology as endpoint for objectively describing volume of retinal detachment'}]}, 'conditionsModule': {'keywords': ['rhegmatogenous retinal detachment', 'detached retina', 'retinal tear', 'retinal break'], 'conditions': ['Retinal Detachment']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test if denufosol will remove the fluid build-up in the eye so that the retina can be re-attached without invasive surgery.', 'detailedDescription': 'The purpose of this trial is to determine if administration of denufosol is well-tolerated and more efficacious than placebo in stimulating subretinal fluid reabsorption and retinal reattachment without surgical intervention in subjects presenting with rhegmatogenous retinal detachment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* have rhegmatogenous retinal detachment in only one eye\n* be able to receive intravitreal injection of study drug and be able to wait 24(+/- 6) hours to have detachment surgically treated or retinal breaks repaired per judgement of investigator\n* no more than 3 separate identifiable retinal breaks that are clustered together and confined within an area no more than 2 clock hours in extent\n* retinal detachment must be large enough such that it cannot be immediately repaired with laser photocoagulation or cryotherapy\n* have pinhole acuity (using ETDRS) of macula-on, 20/50 or better in both eyes OR macula-off, 20/50 or better in non-study eye and have history, prior to detachment, of reading capability in study eye\n\nExclusion Criteria:\n\n* have a non-rhegmatogenous retinal detachment\n* have large retinal break(s) whose total break area is greater than 1 clock hour in extent\n* have evidence of atrophic retinal pigment epithelium, choroid, choroidal detachment or intraocular inflammation\n* be monocular\n* have a prior retinal detachment repair or a congenital condition that places a greater risk for rhegmatogenous retinal detachment\n* have proliferative vitreoretinopathy greater than grade B\n* have pre-existing subretinal or vitreous hemorrhage, corneal opacity, or other conditions which limit the view of peripheral retina\n* have any co-existing macular pathology or other retinal conditions that can limit visual acuity\n* currently have uncontrollable elevated intraocular pressure, advanced glaucoma, or any history or current evidence of endophthalmitis in the affected eye\n* have symptoms consistent with a rhegmatogenous retinal detachment such as visual disturbance greater than 14 days prior to screening if macula-on OR history of loss of reading vision in affected eye for greater than 6 days prior to screening if macula-off\n* have a retinal detachment with evidence of demarcation lines or evidence of subretinal fibrosis visible upon fundus examination\n* be currently taking medications that could obscure or confound study results including acetazolamide (Diamox) and dorzolamide\n* have had a periocular, retrobulbar or intravitreal injection in the affected eye, including corticosteroids in the 3 months prior to screening or require one'}, 'identificationModule': {'nctId': 'NCT00083967', 'briefTitle': 'Study of Denufosol (INS37217) in Subjects With Rhegmatogenous Retinal Detachment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Merck Sharp & Dohme LLC'}, 'officialTitle': 'A Randomized, Double-Masked, Placebo Controlled, Parallel Group, Multi-Center, Dose-Ranging Study of Denufosol Tetrasodium (INS37217) Intravitreal Injection in Subjects With Rhegmatogenous Retinal Detachment', 'orgStudyIdInfo': {'id': '06-102'}}, 'armsInterventionsModule': {'interventions': [{'name': 'denufosol tetrasodium (INS37217) Intravitreal Injection', 'type': 'DRUG'}]}, 'contactsLocationsModule': {'locations': [{'zip': '85704', 'city': 'Tucson', 'state': 'Arizona', 'country': 'United States', 'facility': 'Retina Center, P.C.', 'geoPoint': {'lat': 32.22174, 'lon': -110.92648}}, {'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Retina-Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '90017', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'Retina Vitreous Associates Medical Group', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '92064', 'city': 'Poway', 'state': 'California', 'country': 'United States', 'facility': 'Retina Consultants San Diego', 'geoPoint': {'lat': 32.96282, 'lon': -117.03586}}, {'zip': '06810', 'city': 'Danbury', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Danbury Eye Physicians & Surgeons, P.C.', 'geoPoint': {'lat': 41.39482, 'lon': -73.45401}}, {'zip': '33334', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Retina Group of Florida', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '32806', 'city': 'Orlando', 'state': 'Florida', 'country': 'United States', 'facility': 'Central Florida Retina', 'geoPoint': {'lat': 28.53834, 'lon': -81.37924}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'The University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60435', 'city': 'Joliet', 'state': 'Illinois', 'country': 'United States', 'facility': 'Illinois Retina Associates, S.C.', 'geoPoint': {'lat': 41.52519, 'lon': -88.0834}}, {'zip': '46280', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Midwest Eye Institute', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '40536', 'city': 'Lexington', 'state': 'Kentucky', 'country': 'United States', 'facility': 'University of Kentucky, The Kentucky Clinic', 'geoPoint': {'lat': 37.98869, 'lon': -84.47772}}, {'zip': '04401', 'city': 'Bangor', 'state': 'Maine', 'country': 'United States', 'facility': 'Maine Vitreoretinal Consultants', 'geoPoint': {'lat': 44.79884, 'lon': -68.77265}}, {'zip': '20815', 'city': 'Chevy Chase', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Retina Institute', 'geoPoint': {'lat': 39.00287, 'lon': -77.07115}}, {'zip': '02111', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'New England Eye Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Kresge Eye Institute/Hutzel Hospital', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '64111', 'city': 'Kansas City', 'state': 'Missouri', 'country': 'United States', 'facility': 'Retina Associates', 'geoPoint': {'lat': 39.09973, 'lon': -94.57857}}, {'zip': '07041', 'city': 'Millburn', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Retina Associates of NJ', 'geoPoint': {'lat': 40.72482, 'lon': -74.30404}}, {'zip': '07666', 'city': 'Teaneck', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Retina Associates of NJ', 'geoPoint': {'lat': 40.8976, 'lon': -74.01597}}, {'zip': '07470', 'city': 'Wayne', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Retina Associates of NJ', 'geoPoint': {'lat': 40.92538, 'lon': -74.27654}}, {'zip': '10003', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'NY Eye and Ear Infirmary', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '28387', 'city': 'Southern Pines', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Carolina Eye Associates', 'geoPoint': {'lat': 35.17405, 'lon': -79.39225}}, {'zip': '44122', 'city': 'Beachwood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Retina Associates of Cleveland', 'geoPoint': {'lat': 41.4645, 'lon': -81.50873}}, {'zip': '44107', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Retina Assocites of Cleveland, Inc.', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinical Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '44107', 'city': 'Lakewood', 'state': 'Ohio', 'country': 'United States', 'facility': 'Retina Associates of Cleveland', 'geoPoint': {'lat': 41.48199, 'lon': -81.79819}}, {'zip': '44052', 'city': 'Lorain', 'state': 'Ohio', 'country': 'United States', 'facility': 'Retina Associates of Cleveland', 'geoPoint': {'lat': 41.45282, 'lon': -82.18237}}, {'zip': '44130', 'city': 'Middleburg Heights', 'state': 'Ohio', 'country': 'United States', 'facility': 'Retina Associates of Cleveland', 'geoPoint': {'lat': 41.36144, 'lon': -81.81291}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Scheie Eye Institute', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Retina', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'Vitreoretinal Consultants', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '23505', 'city': 'Norfolk', 'state': 'Virginia', 'country': 'United States', 'facility': 'Wagner Mandell Retina Center', 'geoPoint': {'lat': 36.84681, 'lon': -76.28522}}, {'zip': '23454', 'city': 'Virginia Beach', 'state': 'Virginia', 'country': 'United States', 'facility': 'Wagner Mandell Retina Center', 'geoPoint': {'lat': 36.85293, 'lon': -75.97799}}, {'zip': '53226', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin/The Eye Institute', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}], 'overallOfficials': [{'name': 'Amy Schaberg, BSN', 'role': 'STUDY_DIRECTOR'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Merck Sharp & Dohme LLC', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}