Ignite Creation Date:
2025-12-24 @ 5:19 PM
Ignite Modification Date:
2026-01-23 @ 6:11 PM
Study NCT ID:
NCT05447650
Status:
COMPLETED
Last Update Posted:
2025-06-24
First Post:
2022-06-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)
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': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 95}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-04-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-06-18', 'studyFirstSubmitDate': '2022-06-29', 'studyFirstSubmitQcDate': '2022-07-01', 'lastUpdatePostDateStruct': {'date': '2025-06-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Mean change best corrected distance visual acuity', 'timeFrame': 'Through Month 12 timepoint', 'description': 'Mean change from baseline of best corrected distance visual acuity (CDVA) letter score'}], 'primaryOutcomes': [{'measure': 'Adverse Device Effects', 'timeFrame': 'Through study completion, Month 12 timepoint', 'description': 'Incidence of device- and/or treatment-related serious adverse events (SAEs) and/or serious adverse device effects (SADE) at any point during the study'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isUnapprovedDevice': True, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['AMD', 'Dry AMD'], 'conditions': ['Age-Related Macular Degeneration', 'Dry Age-related Macular Degeneration', 'Nonexudative Age-related Macular Degeneration']}, 'descriptionModule': {'briefSummary': 'Evaluate the safety and efficacy of transpalpebral microcurrent stimulation (MCS) therapy for patients with nonexudative (dry) age-related macular degeneration (AMD).', 'detailedDescription': 'The i-Lumen(TM) AMD device is for in-office therapy use to deliver microcurrent electrical stimulation transpalpebrally (via the eyelid) for use by an ophthalmologist. The i-Lumen AMD device contains proprietary software with preset treatment algorithms and is calibrated at each session to the individual participant.\n\nUp to 30 enrolled participants will be randomized (2:1 active to sham ratio) and complete the initial 5-day loading treatment sessions. Participants completing the initial loading sessions will receive two (2) days of maintenance treatments and be following and be followed through the one (1) year time point.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Age ≥50 years.\n* Non-exudative age-related macular degeneration defined as AREDS category 3 Intermediate AMD and/or geographic atrophy\n* Best-corrected distance visual acuity 20/40 to 20/200 (inclusive) in the study eye, and BCVA 20/100 or better in the fellow eye\n\nKey Exclusion Criteria:\n\n* History and/or evidence of exudative age-related macular degeneration in either eye\n* History and/or evidence of diabetic retinopathy in either eye\n* Current tobacco or tobacco-related product use or history within the past 10 years of heavy smoking (on average, more than half a pack of cigarettes per day)\n* Central chorioretinal atrophy in the study eye\n* Glaucoma in the study eye'}, 'identificationModule': {'nctId': 'NCT05447650', 'acronym': 'i-SIGHT', 'briefTitle': 'Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'i-Lumen Scientific, Inc.'}, 'officialTitle': 'Microcurrent Stimulation Therapy for Nonexudative Age-related Macular Degeneration (i-SIGHT): A Multicenter, Randomized, Sham-controlled, Feasibility Device Trial.', 'orgStudyIdInfo': {'id': 'ILS-AMD-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'i-Lumen AMD Active', 'description': 'Active transpalpebral microcurrent stimulation therapy', 'interventionNames': ['Device: i-Lumen(TM) AMD']}, {'type': 'SHAM_COMPARATOR', 'label': 'i-Lumen AMD Sham', 'description': 'Sham transpalpebral microcurrent stimulation therapy', 'interventionNames': ['Device: i-Lumen(TM) AMD Sham']}], 'interventions': [{'name': 'i-Lumen(TM) AMD', 'type': 'DEVICE', 'description': 'Transpalpebral microcrurrent stimulation', 'armGroupLabels': ['i-Lumen AMD Active']}, {'name': 'i-Lumen(TM) AMD Sham', 'type': 'DEVICE', 'description': 'Transpalpebral sham stimulation', 'armGroupLabels': ['i-Lumen AMD Sham']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85020', 'city': 'Phoenix', 'state': 'Arizona', 'country': 'United States', 'facility': 'Associated Retina Consultants', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '94598', 'city': 'Walnut Creek', 'state': 'California', 'country': 'United States', 'facility': 'Bay Area Retina Associates', 'geoPoint': {'lat': 37.90631, 'lon': -122.06496}}, {'zip': '60439', 'city': 'Lemont', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Retina and Macula Associates, PC', 'geoPoint': {'lat': 41.67364, 'lon': -88.00173}}, {'zip': '21740', 'city': 'Chambersburg', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Cumberland Valley Retina Consultants', 'geoPoint': {'lat': 39.93759, 'lon': -77.6611}}, {'zip': '16507', 'city': 'Erie', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Erie Retina Research, LLC', 'geoPoint': {'lat': 42.12922, 'lon': -80.08506}}, {'zip': '38138', 'city': 'Germantown', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Charles Retina Institute', 'geoPoint': {'lat': 35.08676, 'lon': -89.81009}}, {'zip': '78705', 'city': 'Austin', 'state': 'Texas', 'country': 'United States', 'facility': 'Austin Research Center for Retina', 'geoPoint': {'lat': 30.26715, 'lon': -97.74306}}, {'zip': '77401', 'city': 'Bellaire', 'state': 'Texas', 'country': 'United States', 'facility': 'Retina Consultants of Texas', 'geoPoint': {'lat': 29.70579, 'lon': -95.45883}}, {'zip': '76028', 'city': 'Burleson', 'state': 'Texas', 'country': 'United States', 'facility': 'Star Retina', 'geoPoint': {'lat': 32.54208, 'lon': -97.32085}}, {'zip': '76104', 'city': 'Fort Worth', 'state': 'Texas', 'country': 'United States', 'facility': 'Texas Retina Associates', 'geoPoint': {'lat': 32.72541, 'lon': -97.32085}}], 'overallOfficials': [{'name': 'Meredith Mundy', 'role': 'STUDY_DIRECTOR', 'affiliation': 'i-Lumen Scientific, Inc.'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'i-Lumen Scientific, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}