Ignite Creation Date:
2025-12-24 @ 1:33 PM
Ignite Modification Date:
2025-12-27 @ 10:46 PM
Study NCT ID:
NCT04847895
Status:
COMPLETED
Last Update Posted:
2021-04-19
First Post:
2021-03-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D012170', 'term': 'Retinal Vein Occlusion'}, {'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D020246', 'term': 'Venous Thrombosis'}, {'id': 'D013927', 'term': 'Thrombosis'}, {'id': 'D016769', 'term': 'Embolism and Thrombosis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular 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'}]}, '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': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-04', 'completionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-12', 'studyFirstSubmitDate': '2021-03-26', 'studyFirstSubmitQcDate': '2021-04-12', 'lastUpdatePostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-03-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'mean change in visual acuity', 'timeFrame': 'Baseline, Up to month 24', 'description': 'Visual acuity will be measured according to the method used by each participating physician in his/her routine practice. To be able to integrate different visual acuity assessment methods for analysis, visual acuity assessments performed using Snellen or decimal notation will be converted into an Early Treatment Diabetic Retinopathy Study (ETDRS) letter score equivalent.'}, {'measure': 'mean change in central retinal thickness', 'timeFrame': 'Baseline, Up to month 24', 'description': 'As central retinal thickness data is optional, this analysis will be performed only if data allow.'}], 'secondaryOutcomes': [{'measure': 'Number of treatments', 'timeFrame': 'Up to 24 months', 'description': 'Number of treatments will be provided'}, {'measure': 'Number of visits', 'timeFrame': 'Up to 24 months', 'description': 'Number of visits will be provided'}, {'measure': 'Time interval between treatments', 'timeFrame': 'Up to 24 months', 'description': 'Time interval between treatments will be provided'}, {'measure': 'Time interval between visits', 'timeFrame': 'Up to 24 months', 'description': 'Time interval between visits will be provided'}, {'measure': 'Duration of treatment period', 'timeFrame': 'Up to 24 months', 'description': 'Duration of treatment period will be provided'}, {'measure': 'Maximum period of treatment extension', 'timeFrame': 'Up to 24 months', 'description': 'Maximum period of treatment extension (where applicable)'}, {'measure': 'Number of retreatments', 'timeFrame': 'Up to 24 months', 'description': 'Number of retreatments will be provided'}, {'measure': 'Reasons for retreatment', 'timeFrame': 'Up to 24 months', 'description': 'Reasons for retreatment will be provided'}, {'measure': 'Monitoring and treatment regimen - Therapy schemes', 'timeFrame': 'Up to 24 months', 'description': 'The following therapy schemes are defined:\n\n* Fixed scheme (FIX): Planned interval of (control-) visits: "regular" and planned treatment performance: "at each visit"\n* Pro Re Nata (PRN): Planned interval of (control-) visits: "regular" and planned treatment performance: "as needed"\n* Treat \\& Extend (T+E): Planned interval of (control-) visits: "variable" and planned treatment performance: "at each visit"\n* Monitor \\& Extend (M+E): Planned interval of (control-) visits: "variable" and planned treatment performance: "as needed"\n\nFIX, PRN, T+E and M+E are based on documentation by visit regarding physician\'s planning and will be applied as overall planned therapy scheme, if no different therapy schemes are documented between patient\'s visit.\n\nActual interval of (control-) visits and treatment performance will be derived using the documented visit dates and treatment documentations.'}, {'measure': 'Reasons for choice of treatment regimen', 'timeFrame': 'Up to 24 months', 'description': "Reasons for choice of treatment regimen will be provided. The choice of treatment is described within 5 categories:\n\n* Medical reasons\n* Compability with organisation of practice/clinic\n* Compability with availability of patient\n* Patient's request\n* Other"}, {'measure': 'Monitoring and treatment patterns as a function of health insurances', 'timeFrame': 'Up to 24 months', 'description': 'The results from the above derived monitoring and treatment regimen will be stratified for German patients according to the status of insurance (public health insurance or private health insurance).'}, {'measure': 'Number of treatments with Lucentis® vials and pre-filled syringe', 'timeFrame': 'Up to 24 months', 'description': 'Number of treatments with Lucentis® vials and pre-filled syringe will be provided'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lucentis', 'Ranibizumab', 'Neovascular (wet) age-related macular degeneration', 'nAMD', 'diabetic macular edema', 'retinal vein occlusions', 'choroidal neovascularizations'], 'conditions': ['Neovascular (Wet) Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'This study is designed as an observational, non-interventional, multicenter, open label, single arm study in patients being treated with Lucentis® for any approved indication included in the local product posology.', 'detailedDescription': "The prospective observation period per patient will be up to 24 months. A minimum of one follow-up visit per year is required in order to maintain patient's participation in the study.\n\nThe baseline visit will be used to assess eligibility and collect baseline characteristics information. The follow-up visits will take place at a frequency defined as per investigator's discretion.\n\nThe study eye is defined as the first eye treated during the study, the other eye will be considered as the fellow eye. If both eyes are treated at baseline, the right eye will be chosen as the study eye."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients being treated with Lucentis® for any approved indication included in the local product posology. Patients will be enrolled from approximately 211 centers across Europe.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Male or female patients, ≥18 years of age, being treated with Lucentis® for any approved indication in the local Lucentis® SmPC\n* Written informed consent\n\nExclusion Criteria:\n\n* As described in Lucentis® SmPC\n* Participation in any other clinical study or NIS with Lucentis® as the investigational drug (such as OCEAN or LUMINOUS)'}, 'identificationModule': {'nctId': 'NCT04847895', 'acronym': 'PACIFIC', 'briefTitle': 'Observation of Treatment Patterns With Lucentis® in Real-life Conditions in All Approved Indications', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Observation of Treatment Patterns With Lucentis® (Ranibizumab) in Real-life Conditions in All Approved Indications', 'orgStudyIdInfo': {'id': 'CRFB002ADE28'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Lucentis', 'description': 'Patients administered Lucentis by prescription', 'interventionNames': ['Drug: Lucentis']}], 'interventions': [{'name': 'Lucentis', 'type': 'DRUG', 'description': 'There is no treatment allocation. Patients administered Lucentis by prescription that have started before inclusion of the patient into the study will be enrolled.', 'armGroupLabels': ['Lucentis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '76275', 'city': 'Ettlingen', 'state': 'Baden-Wurttemberg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.94094, 'lon': 8.40763}}, {'zip': '48683', 'city': 'Ahaus', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.07936, 'lon': 7.01344}}, {'zip': '56626', 'city': 'Andernach', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.43109, 'lon': 7.40425}}, {'zip': '86150', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '86179', 'city': 'Augsburg', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.37154, 'lon': 10.89851}}, {'zip': '34454', 'city': 'Bad Arolsen-Meneringhausen', 'country': 'Germany', 'facility': 'Novartis Investigative Site'}, {'zip': '75378', 'city': 'Bad Liebenzell', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.77427, 'lon': 8.72971}}, {'zip': '79713', 'city': 'Bad Säckingen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 47.55371, 'lon': 7.94612}}, {'zip': '76530', 'city': 'Baden-Baden', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 48.7606, 'lon': 8.23975}}, {'zip': '02625', 'city': 'Bautzen', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.18035, 'lon': 14.43494}}, {'zip': '59269', 'city': 'Beckum', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.75571, 'lon': 8.04075}}, {'zip': '10367', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10623', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10629', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '10787', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12057', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '12683', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '13357', 'city': 'Berlin', 'country': 'Germany', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '14163', 'city': 'Berlin', 'country': 'Germany', 'facility': 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