Ignite Creation Date:
2025-12-24 @ 4:49 PM
Ignite Modification Date:
2025-12-27 @ 8:31 PM
Study NCT ID:
NCT00607750
Status:
COMPLETED
Last Update Posted:
2010-10-28
First Post:
2008-01-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['United States']}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'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': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2010-10', 'completionDateStruct': {'date': '2010-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2010-10-26', 'studyFirstSubmitDate': '2008-01-23', 'studyFirstSubmitQcDate': '2008-01-23', 'lastUpdatePostDateStruct': {'date': '2010-10-28', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'To evaluate the safety of ATG003 (mecamylamine HCL ophthalmic solution)', 'timeFrame': 'Day 1 - Week 50'}], 'secondaryOutcomes': [{'measure': 'To evaluate the efficacy of ATG003', 'timeFrame': 'Day 1 - Week 50'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Wet AMD, Comentis, ATG003, mecamylamine'], 'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study is a double-masked, randomized, placebo-controlled study of the safety and preliminary efficacy of ATG003 (topical mecamylamine) in patients receiving maintenance injections of either ranibizumab or bevacizumab. Study Hypothesis: Mecamylamine could be effective in the treatment of neovascular AMD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '56 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* \\> 55 years of age\n* clinical diagnosis of neovascular AMD\n\nExclusion Criteria:\n\n* confounding ocular condition'}, 'identificationModule': {'nctId': 'NCT00607750', 'briefTitle': 'Safety and Efficacy of ATG003 in Patients With AMD Receiving Anti-VEGF', 'organization': {'class': 'INDUSTRY', 'fullName': 'CoMentis'}, 'officialTitle': 'A Phase 2 Randomized, Double-Masked, Study to Evaluate the Safety and Preliminary Efficacy of ATG003 in Patients With Neovascular Age-Related Macular Degeneration (NV-AMD) Receiving Frequent Maintenance Intravitreal Anti-VEGF Antibody Therapy (Ranibizumab or Bevacizumab)', 'orgStudyIdInfo': {'id': 'ATG003-203'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': '1', 'interventionNames': ['Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'ATG003', 'interventionNames': ['Drug: ATG003 (mecamylamine)']}], 'interventions': [{'name': 'ATG003 (mecamylamine)', 'type': 'DRUG', 'description': '1% Ophthalmic solution, eyedrop BID, 48 weeks', 'armGroupLabels': ['ATG003']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Placebo eyedrops, BID, 48 weeks', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Carl Grove, MS', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Comentis, Inc.'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CoMentis', 'class': 'INDUSTRY'}, 'responsibleParty': {'oldNameTitle': 'Carl Grove, President', 'oldOrganization': 'CoMentis, Inc.'}}}}