Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2026-03-02 @ 4:01 PM
Study NCT ID:
NCT02005133
Status:
TERMINATED
Last Update Posted:
2017-02-28
First Post:
2013-12-03
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Prospective, Observational, Multicentre, 2 Year Study Evaluating the Use of Eylea (Aflibercept) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration in UK NHS Opthalmology Clinics
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 188}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2013-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-02', 'completionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-02-27', 'studyFirstSubmitDate': '2013-12-03', 'studyFirstSubmitQcDate': '2013-12-03', 'lastUpdatePostDateStruct': {'date': '2017-02-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-10', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Frequency of aflibercept administration', 'timeFrame': 'Up to 1 year', 'description': "To assess the frequency of clinic visits over a 1 year period in VEGF inhibitor naive wet AMD patients managed in 'real world' clinic settings."}], 'secondaryOutcomes': [{'measure': 'Frequency of clinic visits', 'timeFrame': 'Up to 1 year', 'description': "To assess how frequently aflibercept is administered over a 2 year period to VEGF inhibitor naive wet AMD patients managed in 'real world' clinic settings and to determine how frequently these subjects are seen in the clinic."}, {'measure': 'Aflibercept Administration', 'timeFrame': 'Up to 2 years', 'description': "To assess how frequently aflibercept is administered over 1 year and 2 year periods to prior treated VEGF inhibitor treated wet AMD subjects managed in 'real world' clinic settings and to determine how frequently these subjects are seen in the clinic."}, {'measure': 'Changes in visual acuity from baseline', 'timeFrame': 'Up to 2 years', 'description': 'To assess how visual acuity changes over 1 year and 2 year periods in both VEGF inhibitor naive and prior treated wet AMD subjects that receive aflibercept.'}, {'measure': 'Change in central retinal thickness from baseline', 'timeFrame': 'Up to 2 years', 'description': 'To assess how central retinal thickness (CRT) changes as determined by optical coherence tomography OCT) over a 1 year and 2 year period in both VEGF inhibitor naive and prior treated wet AMD subjects that receive aflibercept'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Wet age-related macular degeneration'], 'conditions': ['Wet Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': "To assess the use of aflibercept over a 2 year period in VEGF inhibitor naive and prior treated wet AMD patients managed in 'real wold' clinic settings."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Male and female subjects diagnosed with visual impairment due to wet AMD who are undergoing routine assessment in UK opthalmology clinics.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n\\- Age greater or equal to 50 years Active choroidal neovascularisation secondary to AMD in one or both eyes which in the opinion of the investigator will benefit from treatment with aflibercept Subject willing and able to provide informed consent\n\nExclusion Criteria:\n\n\\- Patients must not have had any prior use of either bevacizumab or aflibercept\n\nOther protocol-defined inclusion/exclusion criteria may apply'}, 'identificationModule': {'nctId': 'NCT02005133', 'briefTitle': 'A Prospective, Observational, Multicentre, 2 Year Study Evaluating the Use of Eylea (Aflibercept) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration in UK NHS Opthalmology Clinics', 'organization': {'class': 'INDUSTRY', 'fullName': 'Novartis'}, 'officialTitle': 'A Prospective, Observational, Multicentre, 2 Year Study Evaluating the Use of Eylea (Aflibercept) for the Treatment of Neovascular (Wet) Age-related Macular Degeneration in UK NHS Opthalmology Clinics', 'orgStudyIdInfo': {'id': 'CRFB002AGB16'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'VEGF inhibitor naïve'}, {'label': 'VEGF inhibitor prior treated'}]}, 'contactsLocationsModule': {'locations': [{'zip': 'TA1 5DA', 'city': 'Taunton', 'state': 'Somerset', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.01494, 'lon': -3.10293}}, {'zip': 'GU16 7UJ', 'city': 'Frimley', 'state': 'Surrey', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.31667, 'lon': -0.74544}}, {'zip': 'EC1V 2PD', 'city': 'London', 'state': 'United Kingdom', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'BD9 6RJ', 'city': 'Bradford', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.79391, 'lon': -1.75206}}, {'zip': 'LS9 7TF', 'city': 'Leeds', 'state': 'West Yorkshire', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.79648, 'lon': -1.54785}}, {'zip': 'BL4 0JR', 'city': 'Bolton', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.58333, 'lon': -2.43333}}, {'zip': 'BS1 2LX', 'city': 'Bristol', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.45523, 'lon': -2.59665}}, {'zip': 'GU2 5XX', 'city': 'Guildford, Surrey', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.23536, 'lon': -0.57427}}, {'zip': 'CT1 3NG', 'city': 'Kent', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.27893, 'lon': 0.52021}}, {'zip': 'L7 8XP', 'city': 'Liverpool', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.41058, 'lon': -2.97794}}, {'zip': 'SE5 9RS', 'city': 'London', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.50853, 'lon': -0.12574}}, {'zip': 'NE1 4LP', 'city': 'Newcastle upon Tyne', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.97328, 'lon': -1.61396}}, {'zip': 'SO16 6YD', 'city': 'Southampton', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 50.90395, 'lon': -1.40428}}, {'zip': 'SS0 0RY', 'city': 'Southend', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 55.31667, 'lon': -5.63333}}, {'zip': 'SR2 9HP', 'city': 'Sunderland', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 54.90465, 'lon': -1.38222}}, {'zip': 'UB8 3NN', 'city': 'Uxbridge', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 51.5489, 'lon': -0.48211}}, {'zip': 'YO31 8HE', 'city': 'York', 'country': 'United Kingdom', 'facility': 'Novartis Investigative Site', 'geoPoint': {'lat': 53.95763, 'lon': -1.08271}}], 'overallOfficials': [{'name': 'Novartis Pharnmaceuticals', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Novartis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Novartis Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}