Ignite Creation Date:
2025-12-24 @ 4:37 PM
Ignite Modification Date:
2025-12-27 @ 7:25 AM
Study NCT ID:
NCT01542866
Status:
COMPLETED
Last Update Posted:
2018-07-12
First Post:
2011-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 160}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2011-01-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2011-11-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-10', 'studyFirstSubmitDate': '2011-07-01', 'studyFirstSubmitQcDate': '2012-03-01', 'lastUpdatePostDateStruct': {'date': '2018-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-03-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-11-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Threshold value of handheld Health Management Tool (HMT) for choroidal neovascular AMD diagnosis at baseline', 'timeFrame': '16 weeks'}, {'measure': 'Identification of clinically relevant worsening of visual function in the home self testing mVT scores', 'timeFrame': 'baseline to 16 weeks'}], 'secondaryOutcomes': [{'measure': 'Correlation of the handheld Health Management Tool (HMT) home self testing on the days of site visits and the mVT assessments performed during the site visits for absolute values', 'timeFrame': 'after 16 weeks'}, {'measure': 'Correlation between the home deterioration signal and the monthly change in the handheld Health Management Tool (HMT) assessments performed during the site visits', 'timeFrame': 'after 16 weeks'}, {'measure': 'Patient compliance and reliability of performing the home self testing using the handheld Health Management Tool (HMT)', 'timeFrame': 'after 16 weeks'}, {'measure': 'Correlation between absolute values of the handheld Health Management Tool (HMT) and BCVA/ central retinal subfield thickness (CRST)', 'timeFrame': '16 weeks'}, {'measure': 'Correlation of the monthly changes in handheld Health Management Tool(HMT)to those of BCVA / OCT / Clinical examination', 'timeFrame': 'after 16 weeks'}, {'measure': 'Correlation of diagnosis of choroidal neovascular AMD with BCVA/ central retinal subfield thickness', 'timeFrame': 'baseline', 'description': 'The disease diagnoses at baseline will be correlated to values of BCVA and CRST at baseline'}, {'measure': 'Correlation of monthly changes observed with thein the investigator judgment (CJ-C) to BCVA / OCT / Clinical examination', 'timeFrame': 'baseline to 16 weeks', 'description': 'Monthly changes in BCVA /OCT and clinical examination will be compared to clinical relevant changes as judged by the investigator on the CJC.'}, {'measure': 'Patient compliance with the signs and symptom questionnaire', 'timeFrame': 'baseline to 16 weeks', 'description': 'The percentage of completed assessments of the signs \\& symptoms questionnaire on the HMT will be provided'}, {'measure': 'Patient satisfaction regarding the use of the HMT', 'timeFrame': '16 weeks'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ranibizumab', 'Age related Macular Degeneration', 'AMD', 'Health Management Tool', 'HMT', 'Best Corrected Visual Acuity', "Investigator's Clinical Judgement of Change", 'Choroidal Neovascularization', 'Central Retinal Subfield Thickness', 'visual function self test'], 'conditions': ['Age Related Macular Degeneration (AMD)']}, 'descriptionModule': {'briefSummary': 'This is a prospective pilot study to evaluate the usability and applicability of a self monitoring test of visual function with the handheld Health Management Tool (HMT) to remotely monitor neovascular Age Related Macular Degeneration (AMD) to detect a potential change in disease status.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with CNV secondary to AMD and not other causes in at least one eye identified by the investigator to be eligible for ranibizumab treatment\n* Patients with a BCVA letter score in the study eye is 24 or better using an ETDRS chart measured at 4 meters distance\n\nExclusion Criteria:\n\n* Patients with any concurrent ocular condition that may result in visual loss during the study\n* Patients with past (within the prior 6 months) or current use of, or likely need for, systemic medications that are known to be toxic to the lens, retina, or optic nerve\n* Other protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT01542866', 'briefTitle': 'A 16 Week Evaluation of the Novartis Health Management Tool (HMT) in Age Related Macular Degeneration (AMD)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A 16 Week Evaluation of the Novartis Health Management Tool in Assessing Self-test Visual Function in Patients With AMD Treated With Ranibizumab', 'orgStudyIdInfo': {'id': 'CRFB002A2407'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Home Monitoring Test', 'description': 'Health management tool (HMT) for measuring vision impairment', 'interventionNames': ['Other: Health Management Tool (HMT)']}], 'interventions': [{'name': 'Health Management Tool (HMT)', 'type': 'OTHER', 'description': 'Mobile computing platform (ie HMT) which allows subjects to perform home monitoring tests', 'armGroupLabels': ['Home Monitoring Test']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90211', 'city': 'Beverly Hills', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 34.07362, 'lon': -118.40036}}, {'zip': '95819', 'city': 'Sacramento', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.58157, 'lon': -121.4944}}, {'zip': '90503', 'city': 'Torrance', 'state': 'California', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 33.83585, 'lon': -118.34063}}, {'zip': '33901', 'city': 'Fort Myers', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 26.62168, 'lon': -81.84059}}, {'zip': '33770', 'city': 'Largo', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.90979, 'lon': -82.78842}}, {'zip': '34239', 'city': 'Sarasota', 'state': 'Florida', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 27.33643, 'lon': -82.53065}}, {'zip': '62704', 'city': 'Springfield', 'state': 'Illinois', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.80172, 'lon': -89.64371}}, {'zip': '49690', 'city': 'Williamsburg', 'state': 'Michigan', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.77361, 'lon': -85.40396}}, {'zip': '68506', 'city': 'Lincoln', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.8, 'lon': -96.66696}}, {'zip': '68131', 'city': 'Omaha', 'state': 'Nebraska', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.25626, 'lon': -95.94043}}, {'zip': '89144', 'city': 'Las Vegas', 'state': 'Nevada', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.17497, 'lon': -115.13722}}, {'zip': '08753', 'city': 'Toms River', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.95373, 'lon': -74.19792}}, {'zip': '10021', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '14620', 'city': 'Rochester', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 43.15478, 'lon': -77.61556}}, {'zip': '12159', 'city': 'Slingerlands', 'state': 'New York', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 42.62925, 'lon': -73.86457}}, {'zip': '28210', 'city': 'Charlotte', 'state': 'North Carolina', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 35.22709, 'lon': -80.84313}}, {'zip': '45242', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '15122', 'city': 'West Mifflin', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.3634, 'lon': -79.86644}}, {'zip': '57701', 'city': 'Rapid City', 'state': 'South Dakota', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 44.08054, 'lon': -103.23101}}, {'zip': '37660', 'city': 'Kingsport', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.54843, 'lon': -82.56182}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '78240', 'city': 'San Antonio', 'state': 'Texas', 'country': 'United States', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 29.42412, 'lon': -98.49363}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Carematix, VAS (Vital Art and Science)', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'SPONSOR'}}}}