Ignite Creation Date:
2025-12-24 @ 1:19 PM
Ignite Modification Date:
2026-02-11 @ 4:58 AM
Study NCT ID:
NCT02988895
Status:
UNKNOWN
Last Update Posted:
2023-08-30
First Post:
2016-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Episcleral Brachytherapy for the Treatment of Wet AMD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D020256', 'term': 'Choroidal Neovascularization'}], 'ancestors': [{'id': 'D015862', 'term': 'Choroid Diseases'}, {'id': 'D014603', 'term': 'Uveal Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D009389', 'term': 'Neovascularization, Pathologic'}, {'id': 'D008679', 'term': 'Metaplasia'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000615490', 'term': 'Strontium-90'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 11}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2017-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2025-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-28', 'studyFirstSubmitDate': '2016-12-06', 'studyFirstSubmitQcDate': '2016-12-07', 'lastUpdatePostDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-12-09', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2023-05-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Safety of the study intervention', 'timeFrame': '26 weeks', 'description': 'Adverse event assessment'}, {'measure': 'Tolerability of the study intervention', 'timeFrame': 'During procedure', 'description': 'Subject pain score during procedure'}, {'measure': 'Feasibility of the study intervention', 'timeFrame': '1 day', 'description': 'Investigator ability to place the device and deliver a therapeutic dose'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': True}, 'conditionsModule': {'keywords': ['Brachytherapy', 'Wet AMD'], 'conditions': ['Macular Degeneration, Choroidal Neovascularization']}, 'descriptionModule': {'briefSummary': 'This is a prospective, multi-site, safety and feasibility study of the SalutarisMD SMD-DA system for retrobulbar minimally invasive episcleral brachytherapy device in patients receiving and not responding to anti-VEGF therapy for nAMD. The trial will be open label and non-randomized. The study intervention is a one-time intervention and requires no alteration to the standard of care during the follow-up period.', 'detailedDescription': 'Subjects will receive a single brachytherapy treatment and 36 months of follow-up.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Diagnosis of active CNV or PCV due to nAMD\n* Poor or non-responsive to FDA approved intravitreal anti-VEGF therapy for nAMD\n* BCVA 20/63 or worse Snellen equivalent in the study eye\n* Ability to understand nature/purpose of trial and to provide informed consent\n* Ability to undergo diagnostic tests and surgical interventions\n* Ability to follow instructions and complete the trial including all scheduled visits and follow-up\n\nExclusion Criteria:\n\n* Neovascularization other than due to AMD\n* Sub-foveal lesion hemorrhage obscuring \\>50% of lesion\n* Targeted neovascular lesion with greatest linear dimension \\>3750 microns or \\<1000 microns as determined by angiography\n* Presence of subretinal fibrosis, including disciform scar, or retinal pigment epithelial (RPE) atrophy that is extensive or foveal threatening in the study eye\n* An existing retinal pigment epithelial (RPE) tear\n* Previous treatment (excluding vitamins) for nAMD in the study eye other than anti-VEGF therapy in the last 6 months\n* A change in anti-VEGF agent in the previous two administrations\n* Anticipate a change to the anti-VEGF agent during the conduct of the study\n* Other clinically significant ocular co-morbidity including, but not limited to, glaucoma, optic neuropathy of any cause, maculopathy / retinopathy of any cause other than nAMD, scleritis, enophthalmos, microphthalmia, or other co-morbidities that in the investigator's opinion could require medical or surgical intervention to prevent or treat visual loss or media opacity that might result from that condition (i.e. severe cataracts).\n* Previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction\n* High myopia indicated by a history of refractive error of - 6D or greater (spherical equivalent), demonstrated myopic degeneration, or axial length of \\>26.5mm.\n* Subjects with orbital structural abnormalities, such as small (axial length \\<21 mm), deep set globes or other globe dystopias that, in the investigator's clinical judgment, would require a change in the angle of insertion or increase the risk of structural damage from retrobulbar anesthesia, sub-Tenon's anesthesia, or retrobulbar device positioning.\n* Media opacity sufficient to preclude adequate fundoscopy, OCT, or angiography\n* Uncontrolled systemic diseases (e.g. controlled hypertension is acceptable)\n* Type I or type II diabetes mellitus\n* Any previous therapeutic radiation to the head or neck or other areas that may have resulted in a radiation dose to the retina.\n* On anticoagulation or dual anti-platelet therapy with abnormal coagulation panel results.\n* Patient unsuitable for IV or local anesthesia\n* Any contraindication to anti-VEGF, fluorescein, indocyanine green, topical and local anesthetics, topical antiseptics, or topical antibiotics to be used during the study\n* Active ocular or periocular infection or intraocular inflammation\n* Fellow eye with a BCVA of 20/63 Snellen Equivalent or worse, with advanced AMD (neovascular or non-exudative AMD with foveal geographic atrophy), or other vision threatening disease that is not eligible for vision restoring treatment (i.e. inoperable cataracts).\n* Fellow eye is receiving anti-VEGF therapy\n* Have received any investigational treatment for any indication in the previous 30 days\n* Any condition which, in the investigators' opinion, would conflict or otherwise prevent the subject from complying with the required procedures, schedule or other study conduct"}, 'identificationModule': {'nctId': 'NCT02988895', 'acronym': 'NEAMES', 'briefTitle': 'Episcleral Brachytherapy for the Treatment of Wet AMD', 'organization': {'class': 'INDUSTRY', 'fullName': 'Salutaris Medical Devices, Inc.'}, 'officialTitle': 'A Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration', 'orgStudyIdInfo': {'id': 'SMD-201601'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'episcleral brachytherapy', 'description': 'single fraction of 24 Gy Strontium90 episcleral brachytherapy', 'interventionNames': ['Radiation: episcleral brachytherapy']}], 'interventions': [{'name': 'episcleral brachytherapy', 'type': 'RADIATION', 'otherNames': ['Strontium 90'], 'description': 'The study intervention is an outpatient, ambulatory procedure performed under local anesthesia with anesthesia assist.', 'armGroupLabels': ['episcleral brachytherapy']}]}, 'contactsLocationsModule': {'locations': [{'zip': '96701', 'city': '‘Aiea', 'state': 'Hawaii', 'country': 'United States', 'facility': 'Retina Consultants of Hawaii', 'geoPoint': {'lat': 21.38222, 'lon': -157.93361}}, {'zip': '60452', 'city': 'Oak Forest', 'state': 'Illinois', 'country': 'United States', 'facility': 'University Retina', 'geoPoint': {'lat': 41.60281, 'lon': -87.74394}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Salutaris Medical Devices, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}