Ignite Creation Date:
2026-03-26 @ 3:14 PM
Ignite Modification Date:
2026-03-30 @ 3:21 AM
Study NCT ID:
NCT07420361
Status:
COMPLETED
Last Update Posted:
2026-02-19
First Post:
2026-02-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Lutein Iontophoresis in Intermediate AMD and Reticular Pseudodrusen - a Retrospective Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, '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': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2026-02-11', 'studyFirstSubmitDate': '2026-02-01', 'studyFirstSubmitQcDate': '2026-02-11', 'lastUpdatePostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'functional parameter', 'timeFrame': 'August 2023 to August 2024', 'description': 'best corrected visual acuity (logMar)'}, {'measure': 'structural parameter over the course of follow-up', 'timeFrame': 'August 2023 to August 2024', 'description': 'Outer retinal morphology using OCT and changes in FAF, specifically RPD type (1-4)'}, {'measure': 'structural parameter over the course of follow-up', 'timeFrame': 'August 2023 to August 2024', 'description': 'Outer retinal morphology using OCT and changes in FAF, specifically ONL thickness (micrometers)'}, {'measure': 'structural parameter over the course of follow-up', 'timeFrame': 'August 2023 to August 2024', 'description': 'Outer retinal morphology using OCT and changes in FAF, specifically choroidal thickness (micrometers)'}, {'measure': 'structural parameter over the course of follow-up', 'timeFrame': 'August 2023 to August 2024', 'description': 'Outer retinal morphology using OCT and changes in FAF, specifically CMT (micrometers)'}, {'measure': 'structural parameter over the course of follow-up', 'timeFrame': 'August 2023 to August 2024', 'description': 'changes in FAF, (descriptive - iso/hyper/hypofluorescent)'}, {'measure': 'Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]', 'timeFrame': 'August 2023 to August 2024', 'description': 'monitoring of adverse events over the course of the follow up (n)'}], 'secondaryOutcomes': [{'measure': 'functional parameter', 'timeFrame': 'August 2023 to August 2024', 'description': 'mean sensitivity (dB)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transcleral lutein iontophoresis', 'age related macular degeneration', 'reticular pseudodrusen'], 'conditions': ['Intermediate Age-Related Macular Degeneration With Reticular Pseudodrusen']}, 'descriptionModule': {'briefSummary': 'There is limited data available on the efficacy and safety of Transscleral Lutein Iontophoresis (TSLI) in patients with in-termediate age-related macular degeneration (iAMD) and reticular pseudodrusen (RPD).\n\nThis retrospective multicentre study evaluated the functional and morphological outcomes of TSLI in patients with stage 2 and stage 3 iAMD with RPD. Autofluorescence (AF), Optical Coherence Tomography (OCT), Best Corrected Visual Acuity (BCVA), Intraocular Pressure (IOP), Macular Sensitivity (MS) and adverse events, were recorded at baseline, 1 month and 3 months follow-up after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '55 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients from the regions of Naples and Cagliari', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion criteria\n\n* Age between 55 and 80 years old\n* diagnosis of early to intermediate stage dAMD (based on AREDS criteria)\n* presence of RPD\n* Treated with scleral Lutein Iontophoresis\n\nExclusion Criteria:\n\n* GA or MNV in the included eye\n* any prior or any ongoing medical or surgical treatment of the included eye (including intravitreal injections, oral supplementation of lutein, zeaxanthin and or high dietary intake of antioxidants)\n* smokers (consummation of more than 20 cigarettes per day)\n* history of treatment with drugs with a well-known possible ophthalmic side-effect\n* known eye diseases such glaucoma, acute or chronic uveitis, advanced cataract, stage 4 dry eye disease or any opacities of the ocular media that do not permit high-quality imaging examinations\n* manifest refraction outside of -6 and +4 dioptres\n* BCVA \\< 40 EDTRS letters.'}, 'identificationModule': {'nctId': 'NCT07420361', 'briefTitle': 'Lutein Iontophoresis in Intermediate AMD and Reticular Pseudodrusen - a Retrospective Study', 'organization': {'class': 'OTHER', 'fullName': 'University of Naples'}, 'officialTitle': 'Short-term Efficacy and Safety of Transcleral Lutein Iontophoresis in Patients With Intermediate Amd and Reticular Pseudodrusen: a Retrospective Study', 'orgStudyIdInfo': {'id': '273/2024'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'transcleral lutein iontophoresis'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Naples', 'country': 'Italy', 'facility': 'Federico II', 'geoPoint': {'lat': 40.85216, 'lon': 14.26811}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mario Damiano Toro', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Mario Damiano Toro', 'investigatorAffiliation': 'University of Naples'}}}}