Ignite Creation Date:
2025-12-26 @ 10:19 PM
Ignite Modification Date:
2025-12-26 @ 10:19 PM
Study NCT ID:
NCT04659512
Status:
COMPLETED
Last Update Posted:
2020-12-10
First Post:
2020-12-02
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Recurrent Neovascular Age-related Macular Degeneration After Therapy Suspension
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-12', 'completionDateStruct': {'date': '2020-06-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-12-09', 'studyFirstSubmitDate': '2020-12-02', 'studyFirstSubmitQcDate': '2020-12-02', 'lastUpdatePostDateStruct': {'date': '2020-12-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-02-28', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Disease recurrence', 'timeFrame': '12 months', 'description': 'The proportion of patients with recurrent disease within 12 months after the last injection.'}], 'secondaryOutcomes': [{'measure': 'Risk factors for disease recurrence', 'timeFrame': '12 months', 'description': 'Effect of age, lesion type, anatomic parameters (PED, geographic atrophy (GA) and sub macular fibrosis), previous episodes of recurrence and total number of injections before suspension, on risk of reactivation.'}, {'measure': 'Visual outcome', 'timeFrame': '12 months', 'description': 'Change in BCVA at time of recurrence and after resumed therapy.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to investigate prospectively the recurrence rate of active macular neovascularization (MNV) and the visual outcome in patients with nAMD previously on a Treat and Extend regimen where treatment has been discontinued due to disease stability.', 'detailedDescription': 'All study subjects had nAMD and were treated at diagnosis with three monthly aflibercept injections and then subsequently followed in a treat and extend regimen with extensions by two weeks if no signs of disease activity were seen. Hemorrhage, intraretinal macular edema or subretinal fluid were considered signs of disease activity. Patients reaching 12-week intervals without any evidence of disease activity on three consecutive visits, a BCVA between 35-88 letters (Snellen 20/200- 20/20) and a near vision of at least 24 points were eligible for study inclusion.\n\nIf there were signs of recurrent disease activity during the follow-up, study participation was concluded at that point and intravitreal therapy was resumed. Between scheduled visits patients were encouraged to monitor their vision at home using monocular visual assessments and were advised to return earlier than planned if symptoms of visual deterioration or metamorphopsia occurred. At baseline and at every follow-up visit all patients had a full dilated ophthalmic examination. Optical coherence tomography (OCT) images were obtained by using the Zeiss Cirrus OCT instrument (Carl Zeiss Meditec, Inc.,Dublin, Ca). A pigment epithelial detachment (PED) was identified as an elevation of the RPE band and included both serous and fibrovascular PED. Near vision was tested at 40cm with the addition of +3 dioptres to the BCVA refraction. For near vision assessment we used the LIX adult A chart (Ortho-KM, Lund, Sweden) graded in typographical points, the largest text being 24 points and the smallest 4 points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with inactive neovascular AMD reaching 12-week intervals in a treat and extend regimen without any evidence of disease activity on three consecutive visits.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with inactive neovascular AMD reaching 12-week intervals in a treat and extend regimen without any evidence of disease activity on three consecutive visits.\n* BCVA between 35-88 letters (Snellen 20/200- 20/20)\n* Near vision of at least 24 points\n\nExclusion Criteria:\n\n• Active neovascular AMD'}, 'identificationModule': {'nctId': 'NCT04659512', 'briefTitle': 'Recurrent Neovascular Age-related Macular Degeneration After Therapy Suspension', 'organization': {'class': 'OTHER', 'fullName': 'St. Erik Eye Hospital'}, 'officialTitle': 'Recurrent Neovascular Age-related Macular Degeneration After Discontinuation of VEGF Inhibitors Managed in a Treat and Extend Regimen', 'orgStudyIdInfo': {'id': '20171'}}, 'contactsLocationsModule': {'locations': [{'zip': '11282', 'city': 'Stockholm', 'country': 'Sweden', 'facility': 'St Eriks Eye Hospital', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'overallOfficials': [{'name': 'David Epstein', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Sankt Erik Eye Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'St. Erik Eye Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'PI', 'investigatorFullName': 'Anders Kvanta', 'investigatorAffiliation': 'St. Erik Eye Hospital'}}}}