Ignite Creation Date:
2025-12-24 @ 12:02 PM
Ignite Modification Date:
2026-03-27 @ 10:57 PM
Study NCT ID:
NCT07004361
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-06-04
First Post:
2025-05-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Ethical Issues of Using Gene Therapy in the Treatment of AMD
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': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-07-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-05-26', 'studyFirstSubmitDate': '2025-05-26', 'studyFirstSubmitQcDate': '2025-05-26', 'lastUpdatePostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-06-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The experience and current treatment outcomes perceived by patients', 'timeFrame': '1 months', 'description': 'Semi-structured interviews'}], 'secondaryOutcomes': [{'measure': "Patients' perceptions, expectations, and potential concerns regarding gene therapy", 'timeFrame': '1 month', 'description': 'Semi-structured interviews'}, {'measure': "Patients' perception and representation of decisional autonomy in their health decisions", 'timeFrame': '1 month', 'description': 'Semi-structured interviews'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['ethical', 'Age-related Macular Degeneration'], 'conditions': ['Exudative Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to examine the legitimacy of gene therapy use in the treatment of exudative age-related macular degeneration (AMD). This involves questioning its beneficence/non-maleficence ratio given the limited experience with this innovative technology and its irreversible effects, requiring a surgical procedure for administration. Additionally, the study explores patient autonomy in decision-making concerning complex therapeutic approaches and how patients should be supported to best uphold this autonomy.', 'detailedDescription': 'Qualitative research based on semi-structured interviews conducted with patients diagnosed with age-related macular degeneration (AMD), followed in the ophthalmology department of Nantes University Hospital and treated with intravitreal injections. These interviews are structured around three main themes in order to better understand:\n\nThe experience and perception of the current treatment by the patients\n\nTheir perceptions, expectations, and potential concerns regarding gene therapy\n\nTheir perception and understanding of decision-making autonomy in their health decisions'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'exsudative AMD patients in o\\^pthalmology department in CHU Nantes', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with exsudative AMD, male female \\>18 years Patients for whom the doctor could consider gene therapy.\n\nExclusion Criteria:\n\nPatients with atrophic AMD (Age-related Macular Degeneration) Patients with other degenerative retinal diseases than AMD, Patients with with associated cognitive disorders.'}, 'identificationModule': {'nctId': 'NCT07004361', 'briefTitle': 'Ethical Issues of Using Gene Therapy in the Treatment of AMD', 'organization': {'class': 'OTHER', 'fullName': 'Nantes University Hospital'}, 'officialTitle': 'Ethical Issues of Using Gene Therapy in the Treatment of AMD (Age-related Macular Degeneration)', 'orgStudyIdInfo': {'id': 'AP_HM_001'}}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Helene Masse, M.D', 'role': 'CONTACT', 'email': 'helene.masse@chu-nantes.fr', 'phone': '+33 2 53 48 28 57'}, {'name': 'Alexandra Poinas, PhD', 'role': 'CONTACT', 'email': 'alexandra.poinas@chu-nantes.fr', 'phone': '+33 2 53 48 28 57'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nantes University Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}