Ignite Creation Date:
2025-12-25 @ 2:03 AM
Ignite Modification Date:
2025-12-26 @ 3:53 PM
Study NCT ID:
NCT06899360
Status:
RECRUITING
Last Update Posted:
2025-03-27
First Post:
2025-03-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Clinical Progression, Prognostic Factors, and Quality of Life in Patients with 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': 'OTHER', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 200}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2029-10-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-20', 'studyFirstSubmitDate': '2025-03-12', 'studyFirstSubmitQcDate': '2025-03-20', 'lastUpdatePostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-10-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Best-corrected visual acuity (BCVA)', 'timeFrame': 'through study completion, 36 months', 'description': 'visual acuity measured as ETDRS letters'}], 'secondaryOutcomes': [{'measure': 'Self-reported vision-targeted quality of life', 'timeFrame': 'through study completion, 36 months', 'description': 'Self-reported vision-targeted quality of life will be measured using National Eye Institute Visual Functioning Questionnaire 25 (VFQ-25). \\[Score 0-100, higher scores mean a better outcome\\]'}, {'measure': 'Fluid volume (nL) in the retinal compartments', 'timeFrame': 'through study completion, 36 months', 'description': 'Artificial intelligence based fluid analysis. Measurement of fluid volume (nL) in the intraretinal, subretinal and sub retinal pigment epithelium compartments'}, {'measure': 'central retinal thickness', 'timeFrame': 'through study completion, 36 months', 'description': 'central retinal thickness'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['age-related macular degeneration', 'artificial intelligence', 'anti-VEGF'], 'conditions': ['Age-Related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The VERA-AMD study is a prospective, observational study designed to evaluate clinical progression, prognostic factors, and quality of life in patients with age-related macular degeneration (AMD). The study aims to analyze real-world clinical data to identify key predictors of disease progression and functional outcomes, with the goal of optimizing AMD management. The study involves 200 patients aged ≥50 with a confirmed diagnosis of AMD, monitored through routine clinical practice. Primary outcomes include progression rates to advanced AMD and changes in visual acuity, while secondary outcomes focus on retinal morphology and quality of life. Anti-VEGF therapy and AI-based fluid analysis will be integrated to explore their impact on disease progression and patient outcomes.', 'detailedDescription': 'The VERA-AMD study is a prospective, non-interventional, observational study investigating the clinical course, prognostic factors, and quality of life in patients with age-related macular degeneration (AMD). AMD is a leading cause of vision loss among the elderly, manifesting as either neovascular ("wet") AMD (nAMD) or geographic atrophy ("dry") AMD (GA-AMD). Despite advances in treatment, there is considerable variability in disease progression and response to therapy. This study aims to fill this gap by analyzing real-world data to identify predictors of disease progression and functional outcomes, ultimately improving clinical management strategies.\n\nStudy Objectives\n\nThe study\'s main objectives are to:\n\nAssess the clinical progression of AMD in routine clinical practice. Identify prognostic factors associated with favorable or unfavorable disease outcomes.\n\nEvaluate the impact of AMD on patient quality of life using validated questionnaires.\n\nMethodology\n\nDesign: Prospective, non-profit, observational study. Population: 200 patients aged ≥50 years with confirmed AMD in at least one eye. Inclusion Criteria: Confirmed diagnosis of AMD, scheduled follow-up according to clinical practice.\n\nExclusion Criteria: Significant ocular or systemic diseases affecting visual outcomes.\n\nOutcomes\n\nPrimary Outcome: Progression rate to advanced AMD, expressed as cases per 100 patient-years.\n\nSecondary Outcomes: Changes in visual acuity, retinal morphology assessed by optical coherence tomography (OCT), and patient-reported quality of life.\n\nAnti-VEGF Therapy and AI-Based Fluid Analysis\n\nA significant part of the study focuses on the role of anti-VEGF treatment in controlling disease progression, especially in nAMD. Anti-VEGF agents such as aflibercept and ranibizumab are standard treatments for neovascular AMD, aiming to reduce fluid accumulation and neovascularization. The study will explore the relationship between treatment regimens (fixed vs. as-needed dosing) and clinical outcomes, including visual acuity and anatomical changes.\n\nArtificial intelligence (AI)-based analysis of retinal fluid dynamics will be employed using OCT imaging data. Machine learning algorithms will be applied to identify patterns in fluid accumulation and disease progression, improving early detection and personalized treatment approaches.\n\nData Collection and Statistical Analysis\n\nData will be collected through regular clinical visits, OCT imaging, and visual acuity testing. Statistical analysis will include repeated measures models to evaluate disease progression and predictors of clinical outcomes. Sample size calculations anticipate a 5.2% annual progression rate in early/intermediate AMD and a 19.7% rate in advanced AMD, with an 80% statistical power at a 0.05 significance level.\n\nTimeline\n\nInterim analysis after 12 months (50 patients with follow-up). Primary analysis after 12 months (all patients). Follow-up analysis at 36 months. Consent and Ethics\n\nInformed consent will be obtained from all participants. Data will be anonymized and handled according to ethical guidelines and institutional review board (IRB) protocols.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '120 Years', 'minimumAge': '50 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients affected by age-related macular degeneration', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* age ≥ 50 years.\n* confirmed diagnosis of AMD in at least one eye.\n* follow-up scheduled according to standard clinical practice.\n\nExclusion Criteria:\n\n* presence of other significant ocular conditions that could affect visual acuity.\n* systemic conditions that make the patient unsuitable for long-term follow-up.'}, 'identificationModule': {'nctId': 'NCT06899360', 'acronym': 'VERA-AMD', 'briefTitle': 'Evaluation of Clinical Progression, Prognostic Factors, and Quality of Life in Patients with Age-related Macular Degeneration.', 'organization': {'class': 'OTHER', 'fullName': 'University of Udine'}, 'officialTitle': 'Evaluation of Clinical Progression, Prognostic Factors, and Quality of Life in Patients with Age-related Macular Degeneration (VERA-nAMD).', 'orgStudyIdInfo': {'id': 'OCU_DMED_2025_1'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Observational cohort of patients with age-related macular degeneration', 'description': 'Observational cohort of patients with age-related macular degeneration eventually receiving anti-VEGF agents as per clinical practice.'}]}, 'contactsLocationsModule': {'locations': [{'zip': '33100', 'city': 'Udine', 'state': 'UD', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Daniele Veritti', 'role': 'CONTACT', 'email': 'daniele.veritti@uniud.it', 'phone': '+390432559907'}], 'facility': 'Department of Ophthalmology', 'geoPoint': {'lat': 46.0693, 'lon': 13.23715}}], 'centralContacts': [{'name': 'Daniele Veritti', 'role': 'CONTACT', 'email': 'daniele.veritti@uniud.it', 'phone': '+390432559907'}], 'overallOfficials': [{'name': 'Daniele Veritti', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Ophthalmology, University of Udine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Udine', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof.', 'investigatorFullName': 'Daniele Veritti', 'investigatorAffiliation': 'University of Udine'}}}}