Ignite Creation Date:
2025-12-24 @ 11:15 PM
Ignite Modification Date:
2025-12-25 @ 8:52 PM
Study NCT ID:
NCT04764656
Status:
TERMINATED
Last Update Posted:
2025-03-25
First Post:
2021-02-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000622091', 'term': 'brolucizumab'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 81}, 'patientRegistry': False}, 'statusModule': {'whyStopped': 'The study was terminated earlier since the obtained sample was not representative of the Portuguese population, and pointed to the high fragility in evaluating the data, making it difficult to carry out a statistical study and draw valid conclusions.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-05-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-21', 'studyFirstSubmitDate': '2021-02-19', 'studyFirstSubmitQcDate': '2021-02-19', 'lastUpdatePostDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-21', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of patients that are absent of subretinal fluid (SRF) and intra-retinal fluid (IRF) in the study eye', 'timeFrame': 'month 12', 'description': 'This primary study objective will be addressed considering treatment naïve and pre-treated patient eyes included in the study, analyzed as two independent groups (naïve and switch).'}], 'secondaryOutcomes': [{'measure': 'Fluid resolution after initiation of brolucizumab', 'timeFrame': 'month 24', 'description': 'Detailed Outcome Measure will be defined in the Statistical Analysis Plan'}, {'measure': 'Visual Actuity (VA) change from baseline', 'timeFrame': 'Baseline, month 24', 'description': 'Detailed Outcome Measure will be defined in the Statistical Analysis Plan'}, {'measure': 'Characterize Choroidal Neovascularization (CNV) morphology (BIRL) and activity', 'timeFrame': 'month 24', 'description': 'Detailed Outcome Measure will be defined in the Statistical Analysis Plan'}, {'measure': 'Number of injections and total number of visits', 'timeFrame': 'month 24', 'description': 'Detailed Outcome Measure will be defined in the Statistical Analysis Plan'}, {'measure': 'Describe the distribution of injection intervals', 'timeFrame': 'month 24', 'description': 'Detailed Outcome Measure will be defined in the Statistical Analysis Plan'}, {'measure': 'Number of Spectral Contrast Optical Coherence Tomography (SC-OCTs) done', 'timeFrame': 'month 24', 'description': 'Detailed Outcome Measure will be defined in the Statistical Analysis Plan'}, {'measure': 'Characterize the patients switching to another antivascular endothelial growth factor (anti-VEGF)', 'timeFrame': 'month 24', 'description': 'Detailed Outcome Measure will be defined in the Statistical Analysis Plan'}, {'measure': 'Discontinuation rate', 'timeFrame': 'month 24', 'description': 'Detailed Outcome Measure will be defined in the Statistical Analysis Plan'}, {'measure': 'Assess the safety of brolucizumab', 'timeFrame': 'month 24', 'description': 'Detailed Outcome Measure will be defined in the Statistical Analysis Plan'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Beovu', 'Brolucizumab', 'nAMD', 'non-interventional trial', 'fluid resolution'], 'conditions': ['Neovascular Age-related Macular Degeneration (nAMD)']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.novctrd.com/ctrdweb/trialresult/trialresults/pdf?trialResultId=18270', 'label': 'Results for CRTH258APT02 from the Novartis Clinical Trials Website'}]}, 'descriptionModule': {'briefSummary': 'This study is a prospective, observational, non-interventional, multicenter, open-label, single arm study in patients being treated for nAMD with brolucizumab in Portugal.', 'detailedDescription': "Naïve and pre-treated patients will be included after decision to start treatment with brolucizumab and consent is given.\n\nThe baseline visit will be used to assess eligibility and collect baseline characteristics information. The study eye will be defined as the first eye treated during the study; the other eye will be considered as fellow eye. If both eyes are treated at baseline, the eye with the worse visual acuity will be chosen as the study eye (if the visual acuity is measured equal, the treating ophthalmologist defines the study eye upon his discretion). The follow-up visits will take place at a frequency defined as per investigator's discretion. Patients that have not received an intravitreal anti-VEGF injection or visited an eye specialist for at least 6 months will be discontinued from the observation.\n\nRetrospective data will be collected for switch patients starting treatment with brolucizumab for up to six months before baseline. Patients, already being treated with brolucizumab may also be included. Here, retrospective data will be collected since the first brolucizumab injection."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '110 Years', 'minimumAge': '40 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'This study will include an estimated number of 120 naïve patients and 180 switch patients with a diagnosis of nAMD being treated with brolucizumab in private clinics in Portugal during the recruitment period', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Diagnosis of nAMD\n2. Male and Female patients with ≥40 years of age at index\n3. Receipt of at least one injection of brolucizumab during the recruitment period\n4. Signed written informed consent\n\nExclusion Criteria:\n\n1. Patients treated for RVO, DME, mCNV, and have diagnoses of diabetes-related macular degeneration within 6 months prior to the index date\n2. Receipt of any anti-VEGF treatment other than brolucizumab in the study eye at index date\n3. Central subfield of the study eye affected by fibrosis or geographic atrophy or total area of fibrosis \\>50% of the total lesion in the study eye at Screening\n4. Any active intraocular or periocular infection or active intraocular inflammation in either eye at index date\n5. Patients who have been on anti-VEGF treatment for longer than 3 years (before index date)\n6. Patients that have any contraindication and are not eligible for treatment with brolucizumab as according to the SmPC\n7. Any medical or psychological condition in the treating physician's opinion which may prevent the patient from the 24 months study participation\n8. Patients participating in parallel in an interventional clinical trial\n9. Patients participating in parallel in any other NIS generating primary data for an anti-VEGF drug\n10. Retinal pigment epithelial rip/tear in the study eye at Screening or Baseline or current vitreous hemorrhage or history of vitreous hemorrhage in the study eye within 4 weeks prior to Baseline\n11. Subretinal blood affecting the foveal center point and/or \\>50% of the lesion of the study eye at Screening"}, 'identificationModule': {'nctId': 'NCT04764656', 'acronym': 'BLUESKY-PT', 'briefTitle': 'Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for nAMD in Portugal', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'Observational Study to Evaluate Fluid Resolution and Effectiveness of Brolucizumab for Neovascular Age-related Macular Degeneration (nAMD) in Portugal', 'orgStudyIdInfo': {'id': 'CRTH258APT02'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Brolucizumab', 'description': 'Naïve (Patients being the first time treated) and pre-treated patients', 'interventionNames': ['Drug: Brolucizumab']}], 'interventions': [{'name': 'Brolucizumab', 'type': 'DRUG', 'description': 'There is no treatment allocation. Patients administered Brolucizumab by prescription that have started before inclusion of the patient into the study will be enrolled.', 'armGroupLabels': ['Brolucizumab']}]}, 'contactsLocationsModule': {'locations': [{'zip': '00-024', 'city': 'Funchal', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 32.66568, 'lon': -16.92547}}, {'zip': '2410-187', 'city': 'Leiria', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.74362, 'lon': -8.80705}}, {'zip': '1050-078', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1200-473', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1500-473', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1600-209', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1649-020', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '1990-196', 'city': 'Lisbon', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'zip': '4050-115', 'city': 'Porto', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 41.1485, 'lon': -8.61097}}, {'zip': '4520 211', 'city': 'Santa Maria da Feira', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 40.92726, 'lon': -8.54839}}, {'zip': '2300-625', 'city': 'Tomar', 'country': 'Portugal', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 39.60199, 'lon': -8.40924}}], 'overallOfficials': [{'name': 'Novartis Pharmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis Pharmaceuticals'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}