Ignite Creation Date:
2025-12-24 @ 6:52 PM
Ignite Modification Date:
2025-12-30 @ 6:55 AM
Study NCT ID:
NCT00395057
Status:
TERMINATED
Last Update Posted:
2015-09-07
First Post:
2006-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}, {'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal 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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@allergan.com', 'phone': '714-246-4500', 'title': 'Therapeutic Area Head', 'organization': 'Allergan, Inc.'}, 'certainAgreement': {'otherDetails': 'A disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 90 days from the time submitted to the sponsor for review. The sponsor cannot require changes to the communication and cannot extend the embargo', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}, 'limitationsAndCaveats': {'description': 'The study was terminated early due to a company decision (non-safety related). Because the study was terminated early, data for certain outcome measures (ie, "Visual Functioning Questionnaire \\[VFQ\\] at Month 3") were not analyzed.'}}, 'adverseEventsModule': {'description': 'The safety population was used to calculate the number of participants at risk for SAEs and AEs and is the total number of patients that were randomized AND treated.', 'eventGroups': [{'id': 'EG000', 'title': 'AGN 211745 Solution 1000 ug', 'description': 'AGN 211745 Solution 1000 ug', 'otherNumAtRisk': 34, 'otherNumAffected': 29, 'seriousNumAtRisk': 34, 'seriousNumAffected': 4}, {'id': 'EG001', 'title': 'AGN 211745 Solution 300 ug', 'description': 'AGN 211745 Solution 300 ug', 'otherNumAtRisk': 35, 'otherNumAffected': 26, 'seriousNumAtRisk': 35, 'seriousNumAffected': 3}, {'id': 'EG002', 'title': 'AGN 211745 Solution 100 ug', 'description': 'AGN 211745 Solution 100 ug', 'otherNumAtRisk': 35, 'otherNumAffected': 28, 'seriousNumAtRisk': 35, 'seriousNumAffected': 3}, {'id': 'EG003', 'title': 'Ranibizumab 500 ug', 'description': 'Ranibizumab 500 ug', 'otherNumAtRisk': 34, 'otherNumAffected': 24, 'seriousNumAtRisk': 34, 'seriousNumAffected': 9}], 'otherEvents': [{'term': 'Angina pectoris', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 2}], 'organSystem': 'Cardiac disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Conjunctival haemorrhage', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 9}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 12}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 5}], 'organSystem': 'Eye disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Retinal haemorrhage', 'stats': 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{'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Dehydration', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Chronic lymphocytic leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Leukaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Lip neoplasm malignant stage unspecified', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Basal cell carcinoma', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Non-small cell lung cancer', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Benign prostatic hyperplasia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Reproductive system and breast disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Peripheral ischaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 0}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}, {'term': 'Hypertension', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 35, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 34, 'numAffected': 1}], 'organSystem': 'Vascular disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (10.0)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AGN 211745 Solution 1000 ug', 'description': 'AGN 211745 Solution 1000 ug'}, {'id': 'OG001', 'title': 'AGN 211745 Solution 300 ug', 'description': 'AGN 211745 Solution 300 ug'}, {'id': 'OG002', 'title': 'AGN 211745 Solution 100 ug', 'description': 'AGN 211745 Solution 100 ug'}, {'id': 'OG003', 'title': 'Ranibizumab 500 ug', 'description': 'Ranibizumab 500 ug'}], 'classes': [{'categories': [{'measurements': [{'value': '5.9', 'groupId': 'OG000'}, {'value': '2.9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '17.6', 'groupId': 'OG003'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Month 3', 'description': 'Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.', 'unitOfMeasure': 'Percentage of Patients', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).'}, {'type': 'SECONDARY', 'title': 'Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AGN 211745 Solution 1000 ug', 'description': 'AGN 211745 Solution 1000 ug'}, {'id': 'OG001', 'title': 'AGN 211745 Solution 300 ug', 'description': 'AGN 211745 Solution 300 ug'}, {'id': 'OG002', 'title': 'AGN 211745 Solution 100 ug', 'description': 'AGN 211745 Solution 100 ug'}, {'id': 'OG003', 'title': 'Ranibizumab 500 ug', 'description': 'Ranibizumab 500 ug'}], 'classes': [{'categories': [{'measurements': [{'value': '6.17', 'spread': '4.339', 'groupId': 'OG000'}, {'value': '4.29', 'spread': '3.264', 'groupId': 'OG001'}, {'value': '6.54', 'spread': '6.102', 'groupId': 'OG002'}, {'value': '3.89', 'spread': '3.396', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Lesion size as assessed by FA and photography at month 3. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc.', 'unitOfMeasure': 'Millimeters squared (mm^2)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat. The ITT population included all patients who started the study (randomized).'}, {'type': 'SECONDARY', 'title': 'Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AGN 211745 Solution 1000 ug', 'description': 'AGN 211745 Solution 1000 ug'}, {'id': 'OG001', 'title': 'AGN 211745 Solution 300 ug', 'description': 'AGN 211745 Solution 300 ug'}, {'id': 'OG002', 'title': 'AGN 211745 Solution 100 ug', 'description': 'AGN 211745 Solution 100 ug'}, {'id': 'OG003', 'title': 'Ranibizumab 500 ug', 'description': 'Ranibizumab 500 ug'}], 'classes': [{'categories': [{'measurements': [{'value': '484.6', 'spread': '142.21', 'groupId': 'OG000'}, {'value': '413.2', 'spread': '103.59', 'groupId': 'OG001'}, {'value': '437.1', 'spread': '125.46', 'groupId': 'OG002'}, {'value': '269.8', 'spread': '76.72', 'groupId': 'OG003'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Month 3', 'description': 'Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision.', 'unitOfMeasure': 'Microns', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).'}, {'type': 'SECONDARY', 'title': 'Visual Functioning Questionnaire (VFQ) at Month 3', 'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}, {'value': '0', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AGN 211745 Solution 1000 ug', 'description': 'AGN 211745 Solution 1000 ug'}, {'id': 'OG001', 'title': 'AGN 211745 Solution 300 ug', 'description': 'AGN 211745 Solution 300 ug'}, {'id': 'OG002', 'title': 'AGN 211745 Solution 100 ug', 'description': 'AGN 211745 Solution 100 ug'}, {'id': 'OG003', 'title': 'Ranibizumab 500 ug', 'description': 'Ranibizumab 500 ug'}], 'timeFrame': 'Month 3', 'description': 'Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed.', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized). Data for this outcome measure were not analyzed as the study was terminated early.'}, {'type': 'SECONDARY', 'title': 'Time to Treatment With Standard of Care at Month 6', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '35', 'groupId': 'OG001'}, {'value': '35', 'groupId': 'OG002'}, {'value': '34', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'AGN 211745 Solution 1000 ug', 'description': 'AGN 211745 Solution 1000 ug'}, {'id': 'OG001', 'title': 'AGN 211745 Solution 300 ug', 'description': 'AGN 211745 Solution 300 ug'}, {'id': 'OG002', 'title': 'AGN 211745 Solution 100 ug', 'description': 'AGN 211745 Solution 100 ug'}, {'id': 'OG003', 'title': 'Ranibizumab 500 ug', 'description': 'Ranibizumab 500 ug'}], 'classes': [{'categories': [{'measurements': [{'value': '91.0', 'groupId': 'OG000', 'lowerLimit': '86.00', 'upperLimit': '102.0'}, {'value': '91.5', 'groupId': 'OG001', 'lowerLimit': '90.00', 'upperLimit': '119.0'}, {'value': '92.0', 'groupId': 'OG002', 'lowerLimit': '91.00', 'upperLimit': '112.0'}, {'value': '130.5', 'groupId': 'OG003', 'lowerLimit': '96.00', 'upperLimit': '161.0'}]}]}], 'paramType': 'MEDIAN', 'timeFrame': 'Month 6', 'description': 'Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.', 'unitOfMeasure': 'Number of Days', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'Intent-To-Treat (ITT). The ITT population included all patients who started the study (randomized).'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'AGN 211745 Solution 1000 ug', 'description': 'AGN 211745 Solution 1000 ug'}, {'id': 'FG001', 'title': 'AGN 211745 Solution 300 ug', 'description': 'AGN 211745 Solution 300 ug'}, {'id': 'FG002', 'title': 'AGN 211745 Solution 100 ug', 'description': 'AGN 211745 Solution 100 ug'}, {'id': 'FG003', 'title': 'Ranibizumab 500 ug', 'description': 'Ranibizumab 500 ug'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '35'}, {'groupId': 'FG002', 'numSubjects': '35'}, {'groupId': 'FG003', 'numSubjects': '34'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}, {'groupId': 'FG002', 'numSubjects': '2'}, {'groupId': 'FG003', 'numSubjects': '1'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '34'}, {'groupId': 'FG002', 'numSubjects': '33'}, {'groupId': 'FG003', 'numSubjects': '33'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '35', 'groupId': 'BG001'}, {'value': '35', 'groupId': 'BG002'}, {'value': '34', 'groupId': 'BG003'}, {'value': '138', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'AGN 211745 Solution 1000 ug', 'description': 'AGN 211745 Solution 1000 ug'}, {'id': 'BG001', 'title': 'AGN 211745 Solution 300 ug', 'description': 'AGN 211745 Solution 300 ug'}, {'id': 'BG002', 'title': 'AGN 211745 Solution 100 ug', 'description': 'AGN 211745 Solution 100 ug'}, {'id': 'BG003', 'title': 'Ranibizumab 500 ug', 'description': 'Ranibizumab 500 ug'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Customized', 'classes': [{'title': 'Between 45 and 65 years', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '16', 'groupId': 'BG004'}]}]}, {'title': '>=65 years', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '30', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}, {'value': '30', 'groupId': 'BG003'}, {'value': '122', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}, {'value': '76', 'groupId': 'BG004'}]}, {'title': 'Male', 'measurements': [{'value': '15', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '11', 'groupId': 'BG002'}, {'value': '20', 'groupId': 'BG003'}, {'value': '62', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 138}}, 'statusModule': {'whyStopped': 'The study was terminated early due to company decision (non-safety related).', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2007-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-08', 'completionDateStruct': {'date': '2009-02', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-08-25', 'studyFirstSubmitDate': '2006-10-31', 'resultsFirstSubmitDate': '2011-11-09', 'studyFirstSubmitQcDate': '2006-10-31', 'lastUpdatePostDateStruct': {'date': '2015-09-07', 'type': 'ESTIMATED'}, 'resultsFirstSubmitQcDate': '2011-11-09', 'studyFirstPostDateStruct': {'date': '2006-11-02', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2011-12-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Patients With Improvement in Best Corrected Visual Acuity (BCVA) of 15 or More Letters at Month 3', 'timeFrame': 'Month 3', 'description': 'Percentage of patients with improvement in BCVA of 15 or more letters at Month 3. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). An increase in the number of letters read correctly means that vision has improved.'}], 'secondaryOutcomes': [{'measure': 'Lesion Size as Assessed by Fluorescein Angiography (FA) and Photography at Month 3', 'timeFrame': 'Month 3', 'description': 'Lesion size as assessed by FA and photography at month 3. FA is a technique for examining the circulation of the retina (and detecting any leakage) using a dye-tracing method. Photographs are taken with a specialized low-power microscope with an attached camera designed to photograph the interior of the eye, including the retina and optic disc.'}, {'measure': 'Foveal Thickness as Assessed by Optical Coherence Tomography (OCT) at Month 3', 'timeFrame': 'Month 3', 'description': 'Foveal thickness as assessed by OCT at month 3. The fovea is a part of the eye, located in the center of the macula region of the retina. OCT is a laser-based, noninvasive, diagnostic system providing high-resolution, three-dimensional images of the retina. The fovea is responsible for sharp central vision, which is necessary for reading or any activity where visual detail is of primary importance. Normal foveal thickness ranges from 175 to 250 microns. A foveal thickness greater than 250 microns represents worsening vision.'}, {'measure': 'Visual Functioning Questionnaire (VFQ) at Month 3', 'timeFrame': 'Month 3', 'description': 'Visual Functioning Questionnaire (VFQ) at Month 3. The VFQ includes 25 questions which assess visual impairment on functioning and specific aspects of health-related quality of life. Study terminated; data for this outcome measure were not analyzed.'}, {'measure': 'Time to Treatment With Standard of Care at Month 6', 'timeFrame': 'Month 6', 'description': 'Time to treatment with standard-of-care at month 6, defined as the number of days before the use of rescue therapy occurred.'}]}, 'conditionsModule': {'conditions': ['Choroid Neovascularization', 'Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This is a 24-month study to evaluate multiple doses of AGN211745 (previously known as Sirna-027) in treatment of subfoveal choroidal neovascularization associated with age-related macular degeneration'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 50 years or older with "wet" AMD as determined by an ophthalmologist\n* decrease in visual acuity (20/40 to 20/640) in at least one eye\n\nExclusion Criteria:\n\n* Uncontrolled systemic disease\n* History of heart attack or stroke within one year of study entry\n* Symptomatic coronary artery disease\n* Cataracts that interfere with vision'}, 'identificationModule': {'nctId': 'NCT00395057', 'briefTitle': 'A Study Using Intravitreal Injections of a Small Interfering RNA in Patients With Age-Related Macular Degeneration', 'organization': {'class': 'INDUSTRY', 'fullName': 'Allergan'}, 'orgStudyIdInfo': {'id': '211745-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AGN 211745 Solution 1000 ug', 'description': 'AGN 211745 Solution 1000 ug', 'interventionNames': ['Drug: AGN 211745']}, {'type': 'EXPERIMENTAL', 'label': 'AGN 211745 Solution 300 ug', 'description': 'AGN 211745 Solution 300 ug', 'interventionNames': ['Drug: AGN 211745']}, {'type': 'EXPERIMENTAL', 'label': 'AGN 211745 Solution 100 ug', 'description': 'AGN 211745 Solution 100 ug', 'interventionNames': ['Drug: AGN 211745']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Ranibizumab 500 ug', 'description': 'Ranibizumab 500 ug', 'interventionNames': ['Drug: Ranibizumab 500µg']}], 'interventions': [{'name': 'AGN 211745', 'type': 'DRUG', 'otherNames': ['Sirna-027'], 'description': 'AGN 211745 Solution 1000µg injection at Day 1, Month 1, Month 2', 'armGroupLabels': ['AGN 211745 Solution 1000 ug']}, {'name': 'AGN 211745', 'type': 'DRUG', 'otherNames': ['Sirna-027'], 'description': 'AGN 211745 Solution 300µg injections, Day 1, Month 1, Month 2', 'armGroupLabels': ['AGN 211745 Solution 300 ug']}, {'name': 'AGN 211745', 'type': 'DRUG', 'otherNames': ['Sirna-027'], 'description': 'AGN 211745 Solution 100µg injections, Day 1, Month 1, Month 2', 'armGroupLabels': ['AGN 211745 Solution 100 ug']}, {'name': 'Ranibizumab 500µg', 'type': 'DRUG', 'otherNames': ['Lucentis®'], 'description': 'Ranibizumab 500µg injections at Day 1, Month 1, Month 2', 'armGroupLabels': ['Ranibizumab 500 ug']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'city': 'Sydney', 'state': 'New South Wales', 'country': 'Australia', 'geoPoint': {'lat': -33.86785, 'lon': 151.20732}}, {'city': 'Makati', 'country': 'Philippines', 'geoPoint': {'lat': 16.412, 'lon': 121.1226}}], 'overallOfficials': [{'name': 'Medical Director', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Allergan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Allergan', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}