Macular Degeneration, Choroidal Neovascularization Clinical Trial
— NEAMESOfficial title:
A Prospective Study of Episcleral Brachytherapy for the Treatment of Neovascular Age-related Macular Degeneration
| Verified date | August 2023 |
| Source | Salutaris Medical Devices, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Active, not recruiting |
| Enrollment | 11 |
| Est. completion date | May 2025 |
| Est. primary completion date | May 26, 2023 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 50 Years and older |
| Eligibility | Inclusion Criteria: - Diagnosis of active CNV or PCV due to nAMD - Poor or non-responsive to FDA approved intravitreal anti-VEGF therapy for nAMD - BCVA 20/63 or worse Snellen equivalent in the study eye - Ability to understand nature/purpose of trial and to provide informed consent - Ability to undergo diagnostic tests and surgical interventions - Ability to follow instructions and complete the trial including all scheduled visits and follow-up Exclusion Criteria: - Neovascularization other than due to AMD - Sub-foveal lesion hemorrhage obscuring >50% of lesion - Targeted neovascular lesion with greatest linear dimension >3750 microns or <1000 microns as determined by angiography - Presence of subretinal fibrosis, including disciform scar, or retinal pigment epithelial (RPE) atrophy that is extensive or foveal threatening in the study eye - An existing retinal pigment epithelial (RPE) tear - Previous treatment (excluding vitamins) for nAMD in the study eye other than anti-VEGF therapy in the last 6 months - A change in anti-VEGF agent in the previous two administrations - Anticipate a change to the anti-VEGF agent during the conduct of the study - 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). - Previous intraocular surgery in study eye other than for uncomplicated phacoemulsification cataract extraction - High myopia indicated by a history of refractive error of - 6D or greater (spherical equivalent), demonstrated myopic degeneration, or axial length of >26.5mm. - 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. - Media opacity sufficient to preclude adequate fundoscopy, OCT, or angiography - Uncontrolled systemic diseases (e.g. controlled hypertension is acceptable) - Type I or type II diabetes mellitus - Any previous therapeutic radiation to the head or neck or other areas that may have resulted in a radiation dose to the retina. - On anticoagulation or dual anti-platelet therapy with abnormal coagulation panel results. - Patient unsuitable for IV or local anesthesia - Any contraindication to anti-VEGF, fluorescein, indocyanine green, topical and local anesthetics, topical antiseptics, or topical antibiotics to be used during the study - Active ocular or periocular infection or intraocular inflammation - 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). - Fellow eye is receiving anti-VEGF therapy - Have received any investigational treatment for any indication in the previous 30 days - 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 |
| Country | Name | City | State |
|---|---|---|---|
| United States | Retina Consultants of Hawaii | 'Aiea | Hawaii |
| United States | University Retina | Oak Forest | Illinois |
| Lead Sponsor | Collaborator |
|---|---|
| Salutaris Medical Devices, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Safety of the study intervention | Adverse event assessment | 26 weeks | |
| Primary | Tolerability of the study intervention | Subject pain score during procedure | During procedure | |
| Primary | Feasibility of the study intervention | Investigator ability to place the device and deliver a therapeutic dose | 1 day |