OcuDyne System in the Treatment of AMD

  • STATUS
    Recruiting
  • days left to enroll
    3
  • participants needed
    20
  • sponsor
    OcuDyne, Inc.
Updated on 4 October 2022
drusen
geographic atrophy
corrected visual acuity
atrophy

Summary

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

Details
Condition Age-Related Macular Degeneration
Treatment OPTiC System
Clinical Study IdentifierNCT05091476
SponsorOcuDyne, Inc.
Last Modified on4 October 2022

Eligibility

Yes No Not Sure

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
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