Ignite Creation Date:
2025-12-24 @ 3:51 PM
Ignite Modification Date:
2026-01-01 @ 2:11 PM
Study NCT ID:
NCT00536692
Status:
COMPLETED
Last Update Posted:
2008-04-08
First Post:
2007-09-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2010-09-09', 'releaseDate': '2010-08-16'}], 'estimatedResultsFirstSubmitDate': '2010-08-16'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D008269', 'term': 'Macular Edema'}], 'ancestors': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D008464', 'term': 'Mecamylamine'}], 'ancestors': [{'id': 'D009636', 'term': 'Norbornanes'}, {'id': 'D001643', 'term': 'Bridged Bicyclo Compounds'}, {'id': 'D001952', 'term': 'Bridged-Ring Compounds'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D011083', 'term': 'Polycyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-09'}, 'statusVerifiedDate': '2008-04', 'completionDateStruct': {'date': '2008-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2008-04-03', 'studyFirstSubmitDate': '2007-09-26', 'studyFirstSubmitQcDate': '2007-09-26', 'lastUpdatePostDateStruct': {'date': '2008-04-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2007-09-28', 'type': 'ESTIMATED'}}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['macular edema', 'DME', 'diabetic', 'mecamylamine', 'Comentis'], 'conditions': ['Diabetic Macular Edema']}, 'referencesModule': {'references': [{'pmid': '20189159', 'type': 'DERIVED', 'citation': 'Campochiaro PA, Shah SM, Hafiz G, Heier JS, Lit ES, Zimmer-Galler I, Channa R, Nguyen QD, Syed B, Do DV, Lu L, Monk J, Cooke JP, Kengatharan MK, Hsu HH. Topical mecamylamine for diabetic macular edema. Am J Ophthalmol. 2010 May;149(5):839-51.e1. doi: 10.1016/j.ajo.2009.12.005. Epub 2010 Feb 26.'}]}, 'descriptionModule': {'briefSummary': 'This is an open-label study evaluating the safety and tolerability of topical ocular mecamylamine given twice a day in patients with diabetic macular edema (DME). Patients will be treated for 12 weeks.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* macular edema due to diabetic retinopathy\n\nExclusion Criteria:\n\n* vision loss from other ocular disease\n* intraocular surgery within 3 months\n* intraocular anti-VEGF or steroids within 3 months\n* HbA1c \\>12'}, 'identificationModule': {'nctId': 'NCT00536692', 'briefTitle': 'Topical Ocular Mecamylamine in Diabetic Macular Edema (DME)', 'organization': {'class': 'INDUSTRY', 'fullName': 'CoMentis'}, 'officialTitle': 'Phase 2 Study of the Safety and Bioactivity of Topical Ocular Mecamylamine for the Treatment of Diabetic Macular Edema (DME)', 'orgStudyIdInfo': {'id': 'ATG003-202'}}, 'armsInterventionsModule': {'interventions': [{'name': 'mecamylamine', 'type': 'DRUG', 'description': 'topical ocular drops'}]}, 'contactsLocationsModule': {'locations': [{'zip': '94609', 'city': 'Oakland', 'state': 'California', 'country': 'United States', 'facility': 'East Bay Retina Consultants, Inc.', 'geoPoint': {'lat': 37.80437, 'lon': -122.2708}}, {'zip': '21287', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins School of Medicine / Wilmer Eye Institute', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '02114', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Ophthalmic Consultants of Boston', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CoMentis', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Juvenile Diabetes Research Foundation', 'class': 'OTHER'}]}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2010-08-16', 'type': 'RELEASE'}, {'date': '2010-09-09', 'type': 'RESET'}], 'unpostedResponsibleParty': 'CoMentis, Inc. (Carl Grove)'}}}}