Ignite Creation Date:
2025-12-24 @ 11:17 PM
Ignite Modification Date:
2026-01-01 @ 9:48 AM
Study NCT ID:
NCT03679156
Status:
COMPLETED
Last Update Posted:
2018-09-20
First Post:
2018-09-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 18}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-05-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-04-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-19', 'studyFirstSubmitDate': '2018-09-19', 'studyFirstSubmitQcDate': '2018-09-19', 'lastUpdatePostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-11-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'visual acuity', 'timeFrame': '93 months', 'description': 'visual acuity testing was performed'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Neovascular Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Purpose:\n\nTo assess retinal pigment epithelial (RPE) and retinal structural changes in eyes with neovascular age-related macular degeneration (AMD) treated with anti-vascular endothelial growth factor (anti-VEGF) during long-term follow-up and to evaluate morphological markers potentially influencing prognosis.\n\nMethods:\n\n18 patients (18 eyes) with neovascular AMD were recruited subsequent to completion the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) study following a mean period of 84 months (range: 69-93 months). After receiving a loading dose of 3 intravitreal anti-VEGF injections subsequent to baseline of the MANTA study, patients were treated as-needed \\[pro re nata (PRN)\\]. Functional and morphological changes were assessed using spectral domain optical coherence tomography (SD-OCT).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'maximumAge': '98 Years', 'minimumAge': '66 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Initially 55 Participants were included in the Avastin Versus Lucentis in Age Related Macular Degeneration (MANTA) trial \\[16\\]. These patients received a loading dose of 3 intravitreal injections of anti-VEGF and were subsequently treated as-needed \\[pro re nata (PRN)\\] \\[16\\]. From that study population we recruited for another long term follow up visit. Of these patients 9 (16%) were excluded due to missed visits, another 14 patients (25%) died before the last study visit and 14 former participants (25%) did not approve further study participation.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Inclusion and exclusion criteria corresponded to the criteria of the MANTA study\n\nExclusion Criteria:\n\n* Inclusion and exclusion criteria corresponded to the criteria of the MANTA study'}, 'identificationModule': {'nctId': 'NCT03679156', 'briefTitle': 'Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor', 'organization': {'class': 'OTHER', 'fullName': 'Hospital Hietzing'}, 'officialTitle': 'Retinal Pigment Epithelial Characteristics in Eyes With Neovascular Age-related Macular Degeneration Following Long-term Treatment With Anti Neovascular Endothelial Growth Factor', 'orgStudyIdInfo': {'id': 'RPE characteristics'}}, 'armsInterventionsModule': {'interventions': [{'name': 'OCT', 'type': 'DEVICE', 'description': 'Patients were recruited, visual acuity and optical coherence tomography Pictures were taken'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hospital Hietzing', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Dr.', 'investigatorFullName': 'Dr. Clara Wernigg', 'investigatorAffiliation': 'Hospital Hietzing'}}}}