OcuDyne System in the Treatment of AMD

This study evaluates the safety and feasibility of using the OcuDyne OPTiC System in patients with late-stage non-exudative age-related macular degeneration.

Inclusion criteria

• Must be able to understand and provide informed consent on an Independent Ethics Committee (EC) approved informed consent form (ICF)
• Must be willing and able to return for scheduled treatment and follow-up examinations for up to a 7-month duration
• Adults at least 60 years of age at the time of consent
• Diagnosed with non-exudative Age-Related Macular Degeneration with current or previous evidence of at least one large drusen (measuring 125 microns or greater) and nascent geographic atrophy (nGA) or GA in the study eye
• ETDRS best corrected visual acuity (BCVA) letter score of less than 56 letters (Snellen equivalent of 20/80 or worse) in the study eye, which in the Investigator's judgment is caused by non-exudative age-related macular degeneration (AMD)
• The confirmed presence of ophthalmic artery (OA) stenosis (leading to the study eye).

Exclusion criteria

OCULAR

• Any surgical intraocular treatment (including laser) within 3 months in the study eye.
• History of exudative AMD or Anti-Vascular Endothelial Growth Factor (anti-VEGF) injections within 6 months in the study eye.
• Presence of ocular media affecting visual acuity or the ability to visualize the retina in either eye (e.g., central corneal scarring, lens opacities along visual axis, posterior capsule opacification, etc.).
• History of chronic, recurring inflammatory eye disease in either eye (e.g., scleritis, uveitis, corneal edema, etc.)
• Presence of diabetic retinopathy in either eye.
• Evidence of macular edema secondary to exudation in the study eye.
• History of amaurosis fugax, central or retinal artery or vein occlusion, anterior ischemic optic neuropathy (AION) or non-arteritic anterior ischemic optic neuropathy (NAION) or any diagnosis of a macular disease other than AMD such as Stargardt disease, cone rod dystrophy, angioid streaks, or toxic maculopathies such as Plaquenil maculopathy.
• Myopia > 6.0 Diopters (D) spherical equivalent (SE) or Axial Length ≥ 26.0 mm in the study eye.
• Presence of visually significant epiretinal membrane in the study eye.
• Participation in any eye-related drug or device clinical trial involving either eye within 90 days prior to enrolling in this study and/or during study participation.

Non-Ocular

• Any condition that prohibits the use of intravenous contrast agents (e.g., renal insufficiency, previous anaphylactoid reaction to contrast material, treatment with nephrotoxic agents, etc.).
• Previous stroke, including ischemic, hemorrhagic or transient ischemic attack (TIA).
• Previous myocardial infarction (MI), including ST segment elevation (STEMI), non-ST segment elevation (NSTEMI) or coronary spasm/angina.
• Coronary or other intravascular percutaneous procedure, including balloon angioplasty, stent or filter placement within the last 6 months.
• Complete occlusion of the ophthalmic artery.
• Pacemaker, Cochlear, or neurostimulation implant.
• Presence of cranial aneurysm, clinically significant stenosis in common carotid artery or internal carotid artery, or tortuous vascular anatomy as seen on pre-procedural CT Angiogram that, in the clinical judgement of the investigator, represents an unreasonable risk to perform the intervention.
• Condition associated with increased bleeding risk including but not limited to: major surgical procedure or trauma within 30 days of screening; clinically significant gastrointestinal bleeding within 1 year of screening; known gastric or duodenal ulcer; history of intracranial or spinal bleeding; chronic hemorrhagic disorder; treatment with oral anticoagulant medications (e.g., Warfarin / non-vitamin K anticoagulants [NOACs] exclusionary; aspirin or clopidogrel allowed), known intracranial neoplasm, arteriovenous malformation, or aneurysm.
• Treatment with oral anticoagulant medications (e.g., Warfarin / non-vitamin K anticoagulants [NOACs] exclusionary; aspirin or clopidogrel allowed).
• Sustained and uncontrolled hypertension with systolic blood pressure > 180 mmHg.
• Diagnosis of moderate to severe symptomatic congestive heart failure (CHF) or chronic obstructive pulmonary disease (COPD)
• Diagnosis of connective tissue, demyelinating, autoimmune, or inflammatory diseases (e.g., lupus, rheumatoid arthritis, scleroderma, giant cell arteritis, multiple sclerosis, etc.).
• Intolerance of either pre- or post- procedure medication regimen.
• Pregnancy, lactation, or plans to become pregnant during participation in this clinical trial.
• Participation in any other non-eye related drug or device clinical trial within 30 days prior to enrolling in this study and/or during study participation.

Other

• Use of facial fillers or paralytic drugs during study participation.
• Subject who, in the clinical judgement of the investigator, is not otherwise suitable for participation in the study for another clinical reason, as documented by the investigator.