Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-29 @ 5:32 PM
Study NCT ID:
NCT06906003
Status:
RECRUITING
Last Update Posted:
2025-04-02
First Post:
2025-02-27
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Visual Rehabilitation and Depression in Visually Impaired Patients with AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008268', 'term': 'Macular Degeneration'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D012162', 'term': 'Retinal Degeneration'}, {'id': 'D012164', 'term': 'Retinal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 22}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-12-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2025-02-27', 'studyFirstSubmitQcDate': '2025-03-25', 'lastUpdatePostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program', 'timeFrame': '12 weeks', 'description': 'Generalised Anxiety Disorder score (GAD-7, range 0-21,higher scores mean worse outcome) changes after rehabilitation program'}, {'measure': 'Changes of anxiety and depression status in visually impaired patients with AMD undergoing visual rehabilitation program', 'timeFrame': '12 weeks', 'description': 'Patient Health Questionnaire score (PHQ-9, range 0-27, higher scores mean worse outcome) changes after rehabilitation program'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['AMD - Age-Related Macular Degeneration', 'Anxiety', 'Depression Disorders']}, 'descriptionModule': {'briefSummary': "Purpose: The aim of this study is to evaluate the impact of visual rehabilitation in visually impaired patients with advanced AMD by the use of questionnaires on the anxiety and depression status.\n\nStudy design: prospective observational study. The study is carried out at the IRCCS Fondazione G.B.Bietti and at the UO Visual Rehabilitation, S. Alessio - Margherita di Savoia.\n\nStudy procedures: Visit 1 (screening visit, at IRCCS Fondazione Bietti) After signing the informed consent, all patients received a complete ophthalmological examination, non-invasive diagnostic tests as optical coherence tomography, autofluorescence and microperimetry, and have to complete the questionnaires on the state of anxiety and depression (GAD-7 and PHQ-9).\n\nVisit 2 (at the Sant'Alessio Institute) for a 60-day visual rehabilitation program scheduled in 5 group meetings.\n\nVisit 3 (end-of-study visit, at IRCCS Fondazione G.B. Bietti) complete ophthalmological examination, as per clinical practice, non-invasive diagnostic tests such as microperimetry, optical coherence tomography and autofluorescence and administration of the Patient Health Questionnaire-9 (PHQ-9) questionnaires for depression and the General Anxiety Disorder (GAD-7) questionnaires for anxiety."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Moderate and severe visually impaired patients affected by non exudative AMD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Subjects ≥ 55 years\n2. Moderate and severe visual impairment (BCVA ≥1/10 and ≤2/10)\n3. Diagnosis of advanced non-exudative age-related macular degeneration (AMD)\n4. Informed consent freely granted and acquired before the start of the study\n5. Ability to understand and willingness to follow the study instructions and procedures\n\nExclusion Criteria:\n\n1. Visual impairment due to other ocular diseases\n2. Mild visual impairment or partial or total blindness\n3. Exudative age-related macular degeneration undergoing intravitreal drug treatment'}, 'identificationModule': {'nctId': 'NCT06906003', 'acronym': 'RET 06-24', 'briefTitle': 'Visual Rehabilitation and Depression in Visually Impaired Patients with AMD', 'organization': {'class': 'OTHER', 'fullName': 'Fondazione G.B. Bietti, IRCCS'}, 'officialTitle': 'Evaluation of the Impact of Visual Rehabilitation on Anxiety and Depression Severity of Visually Impaired Patients with Advanced Age Related Macular Degeneration', 'orgStudyIdInfo': {'id': 'RET 06-24'}}, 'armsInterventionsModule': {'interventions': [{'name': 'visual rehabilitation program', 'type': 'OTHER', 'description': 'I. meeting: coin recognition II. meeting: reading stories and audio books\' listening III. meeting: installation of APPs on their smartphones and tablets and use of voice assistant IV. meeting: management of "table" activities V. meeting: meeting with caregivers.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '00184', 'city': 'Rome', 'state': 'Italy', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Eliana Costanzo, MD', 'role': 'CONTACT', 'email': 'eliana.costanzo@fondazionebietti.it', 'phone': '+390684009442'}], 'facility': 'IRCCS Fondazione G.B.Bietti', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'centralContacts': [{'name': 'Eliana Costanzo, MD', 'role': 'CONTACT', 'email': 'eliana.costanzo@fondazionebietti.it', 'phone': '+390684009442'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Fondazione G.B. Bietti, IRCCS', 'class': 'OTHER'}, 'collaborators': [{'name': "Sant'Alessio - Margherita di Savoia", 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}