Ignite Creation Date:
2025-12-25 @ 1:32 AM
Ignite Modification Date:
2025-12-25 @ 11:45 PM
Study NCT ID:
NCT00590694
Status:
COMPLETED
Last Update Posted:
2012-04-12
First Post:
2007-12-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012163', 'term': 'Retinal Detachment'}, {'id': 'D057135', 'term': 'Wet Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069579', 'term': 'Ranibizumab'}], 'ancestors': [{'id': 'D061067', 'term': 'Antibodies, Monoclonal, Humanized'}, {'id': 'D000911', 'term': 'Antibodies, Monoclonal'}, {'id': 'D000906', 'term': 'Antibodies'}, {'id': 'D007136', 'term': 'Immunoglobulins'}, {'id': 'D007162', 'term': 'Immunoproteins'}, {'id': 'D001798', 'term': 'Blood Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D012712', 'term': 'Serum Globulins'}, {'id': 'D005916', 'term': 'Globulins'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2', 'PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2006-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-04', 'completionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-04-10', 'studyFirstSubmitDate': '2007-12-26', 'studyFirstSubmitQcDate': '2008-01-10', 'lastUpdatePostDateStruct': {'date': '2012-04-12', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-01-11', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2009-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Mean change in visual acuity from baseline over 12 months', 'timeFrame': '12 months'}], 'secondaryOutcomes': [{'measure': 'Time to OCT resolution of macular edema and pigment epithelial detachment', 'timeFrame': 'One year'}, {'measure': 'Proportion of patients with complete resolution of PED at 6 and 12 months', 'timeFrame': '12 months'}, {'measure': 'Durability of outcome: time from last ranibizumab injection to retreatment', 'timeFrame': 'One year'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['ranibizumab', 'Lucentis', 'Pigment Epithelial Detachment', 'Macular Degeneration', 'PrONTO'], 'conditions': ['Age-related Macular Degeneration', 'Pigment Epithelial Detachment', 'Neovascular Macular Degeneration', 'Wet Macular Degeneration']}, 'referencesModule': {'references': [{'pmid': '17386270', 'type': 'BACKGROUND', 'citation': 'Fung AE, Lalwani GA, Rosenfeld PJ, Dubovy SR, Michels S, Feuer WJ, Puliafito CA, Davis JL, Flynn HW Jr, Esquiabro M. An optical coherence tomography-guided, variable dosing regimen with intravitreal ranibizumab (Lucentis) for neovascular age-related macular degeneration. Am J Ophthalmol. 2007 Apr;143(4):566-83. doi: 10.1016/j.ajo.2007.01.028.'}], 'seeAlsoLinks': [{'url': 'http://www.pacificeye.com/', 'label': 'Pacific Eye Associates website'}]}, 'descriptionModule': {'briefSummary': 'Patients with neovascular Age-related macular degeneration (AMD) and the particular feature of pigment epithelial detachments (PEDs) were not studied in the Phase III trials for ranibizumab (Lucentis). The PrONTO study was the first ranibizumab study to enroll such patients but only treated with ranibizumab until fluid within the layers of the retina was absent, not until the entire PED was absent. This study hypothesizes that there may be a difference in benefit between patients treated until just the retinal edema is gone and those in which the retinal edema and PED are both gone.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Neovascular age-related macular degeneration patients over age 50\n* Presence of a pigment epithelial detachment on optical coherence tomography\n* Initial or recurrent disease\n* Previous treatment allowed\n* Visual acuity between Snellen 20/40 - 20/400\n\nExclusion Criteria:\n\n* More than three previous treatments with PDT or other radiation/laser therapy\n* Previous vitrectomy or other AMD surgical intervention\n* Severe scarring or severe concurrent ocular disease (uncontrolled glaucoma)\n\nPatients eligible for the study are randomized into one of two groups. Group 1 receives injections of ranibizumab until retinal edema is resolved. Group 2 receives ranibizumab injections until both retinal edema and the PED are resolved. Study duration is one year with visits once per month.'}, 'identificationModule': {'nctId': 'NCT00590694', 'acronym': 'DETAIL', 'briefTitle': 'Lucentis for Age-related Macular Degeneration Pigment Epithelial Detachments', 'organization': {'class': 'OTHER', 'fullName': 'Pacific Eye Associates'}, 'officialTitle': 'Determining Optimal Treatment Algorithms for Macular Degeneration Pigment Epithelial Detachments Treated With Intraocular Lucentis', 'orgStudyIdInfo': {'id': 'DETAIL Study for PED in AMD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Group1', 'description': 'Will receive ranibizumab treatments until resolution of macular edema only and as macular edema recurs.', 'interventionNames': ['Drug: ranibizumab']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group 2', 'description': 'Will receive ranibizumab treatments until resolution of both macular edema and PED, and as macular edema or PED recur.', 'interventionNames': ['Drug: ranibizumab']}], 'interventions': [{'name': 'ranibizumab', 'type': 'DRUG', 'otherNames': ['Lucentis injection'], 'description': '0.5mg injection monthly according to protocol for one year', 'armGroupLabels': ['Group 2', 'Group1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94115', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'Pacific Eye Associates', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}], 'overallOfficials': [{'name': 'Anne Fung, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pacific Eye Associates / California Pacific Medical Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pacific Eye Associates', 'class': 'OTHER'}, 'collaborators': [{'name': 'Genentech, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}