Ignite Creation Date:
2025-12-24 @ 1:03 PM
Ignite Modification Date:
2025-12-30 @ 4:13 PM
Study NCT ID:
NCT03035461
Status:
COMPLETED
Last Update Posted:
2020-08-04
First Post:
2017-01-25
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration
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': 250}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-07', 'completionDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-07-31', 'studyFirstSubmitDate': '2017-01-25', 'studyFirstSubmitQcDate': '2017-01-26', 'lastUpdatePostDateStruct': {'date': '2020-08-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-01-30', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': "Description of the patient's feelings", 'timeFrame': 'up to 1 month after diagnosis', 'description': 'A questionnaire with a list of different feelings: anxiety, distress, relief, resigned, guilty, etc. is proposed to the patient after AMD diagnosis. they can also explain their feelings by themselves.'}], 'secondaryOutcomes': [{'measure': 'score of general satisfaction', 'timeFrame': 'up to 1 month after diagnosis', 'description': 'the patient will score their satisfaction on a numeric scale from 0 (not satisfied at all) to 10 (extremely satisfied)'}, {'measure': 'score on a comprehension quiz on AMD', 'timeFrame': 'up to 1 month after diagnosis'}, {'measure': 'Score on a composite score evaluating the clarity of medical explanations', 'timeFrame': 'up to 1 month after diagnosis'}, {'measure': 'Score on a composite score evaluating the clarity of medical explanations', 'timeFrame': 'between 6 months and 1 year of follow-up'}, {'measure': 'score of satisfaction of announcement conditions', 'timeFrame': 'up to 1 month after diagnosis'}, {'measure': 'score of satisfaction of announcement conditions', 'timeFrame': 'between 6 months and 1 year of follow-up'}, {'measure': 'score of satisfactions regarding the clarity of the disease course and treatment explanations', 'timeFrame': 'between 6 months and 1 year of follow-up'}, {'measure': 'Score on the anxiety PHQ9 questionnaire', 'timeFrame': 'between 6 months and 1 year of follow-up'}, {'measure': 'Score on the anxiety GAD7 questionnaire', 'timeFrame': 'between 6 months and 1 year of follow-up'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diagnosis annoucement', "patient's feelings"], 'conditions': ['Age Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Age-related macular degeneration (AMD) is the leading cause of blindness in the elderly population of the industrialized world. AMD is a progressive degenerative disease affecting the central area of the retina, responsible for distinct vision. Vision loss arises from aberrant new vessel growth which causes the accumulation of blood or fluid within the retina\'s thickness and eventually leads to permanent scarring. The two major forms of AMD are exudative, or neovascular or "wet", and non-exudative, or "dry".\n\nVascular endothelial growth factor (VEGF) represents the key modulator of the angiogenetic process and is involved in the pathophysiology of AMD. Anti VEGF therapies are used to treat wet-AMD.\n\nAfter diagnosis and explanations of the practionner, the patients and their close relatives have still frequently many questions about the intravitreal injections, the prognosis, the risk of visual impairment, etc. Few teams have studied the modalities of diagnosis announcement and the understanding of the patients on the disease course.\n\nThe aim of this study is to evaluate the feelings after the AMD diagnosis announcement as well as the understanding of the possibilities of treatment and the clinical surveillance.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with a diagnosis of wet AMD seen in the ophtalmologic department of the CHI creteil', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* patient up to 55 years old\n* wet AMD\n* diagnostic questionnaire group: patient being announced with AMD for less than 1 month\n* disease course questionnaire group: patients treated by anti-VEGF from 6 to 12 months\n\nExclusion Criteria:\n\n* dry AMD\n* patient under 55 years old\n* patient who doesn't speak French\n* patient carrying an ophtalmologic genetic disorder"}, 'identificationModule': {'nctId': 'NCT03035461', 'acronym': 'PANDA', 'briefTitle': "Patient's Feelings After Receiving a Diagnosis of Age-related Macular Degeneration", 'organization': {'class': 'OTHER', 'fullName': 'Centre Hospitalier Intercommunal Creteil'}, 'officialTitle': "Ressenti du Patient au Moment de l'Annonce du Diagnostic de DMLA", 'orgStudyIdInfo': {'id': 'PANDA'}}, 'contactsLocationsModule': {'locations': [{'zip': '94000', 'city': 'Créteil', 'state': 'Creteil', 'country': 'France', 'facility': 'Marciano Joelle', 'geoPoint': {'lat': 48.79266, 'lon': 2.46569}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre Hospitalier Intercommunal Creteil', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Orthoptist in the ophtalmologic department of the CHI Creteil', 'investigatorFullName': 'Joëlle Marciano', 'investigatorAffiliation': 'Centre Hospitalier Intercommunal Creteil'}}}}