OcuDyne System in the Treatment of AMD

Last updated: February 11, 2025
Sponsor: OcuDyne, Inc.
Overall Status: Completed

Phase

N/A

Condition

Macular Degeneration

Aging

Geographic Atrophy

Treatment

OPTiC System

Clinical Study ID

NCT05091476
OC-1901AR
  • Ages > 60
  • All Genders

Study Summary

Feasibility of the OcuDyne OPTiC System in patients with late-stage non-exudative age-related macular degeneration.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Must be able to understand and provide informed consent on an Independent EthicsCommittee (EC) approved informed consent form (ICF)

  2. Must be willing and able to return for scheduled treatment and follow-upexaminations for up to a 7-month duration

  3. Adults at least 60 years of age at the time of consent

  4. Diagnosed with non-exudative Age-Related Macular Degeneration with current orprevious evidence of at least one large drusen (measuring 125 microns or greater)and nascent geographic atrophy (nGA) or GA in the study eye

  5. 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'sjudgment is caused by non-exudative age-related macular degeneration (AMD)

  6. The confirmed presence of ophthalmic artery (OA) stenosis (leading to the studyeye).

Exclusion

Exclusion Criteria:

OCULAR

  1. Any surgical intraocular treatment (including laser) within 3 months in the studyeye.

  2. History of exudative AMD or Anti-Vascular Endothelial Growth Factor (anti-VEGF)injections within 6 months in the study eye.

  3. Presence of ocular media affecting visual acuity or the ability to visualize theretina in either eye (e.g., central corneal scarring, lens opacities along visualaxis, posterior capsule opacification, etc.).

  4. History of chronic, recurring inflammatory eye disease in either eye (e.g.,scleritis, uveitis, corneal edema, etc.)

  5. Presence of diabetic retinopathy in either eye.

  6. Evidence of macular edema secondary to exudation in the study eye.

  7. History of amaurosis fugax, central or retinal artery or vein occlusion, anteriorischemic optic neuropathy (AION) or non-arteritic anterior ischemic optic neuropathy (NAION) or any diagnosis of a macular disease other than AMD such as Stargardtdisease, cone rod dystrophy, angioid streaks, or toxic maculopathies such asPlaquenil maculopathy.

  8. Myopia > 6.0 Diopters (D) spherical equivalent (SE) or Axial Length ≥ 26.0 mm in thestudy eye.

  9. Presence of visually significant epiretinal membrane in the study eye.

  10. Participation in any eye-related drug or device clinical trial involving either eyewithin 90 days prior to enrolling in this study and/or during study participation. Non-Ocular

  11. Any condition that prohibits the use of intravenous contrast agents (e.g., renalinsufficiency, previous anaphylactoid reaction to contrast material, treatment withnephrotoxic agents, etc.).

  12. Previous stroke, including ischemic, hemorrhagic or transient ischemic attack (TIA).

  13. Previous myocardial infarction (MI), including ST segment elevation (STEMI), non-STsegment elevation (NSTEMI) or coronary spasm/angina.

  14. Coronary or other intravascular percutaneous procedure, including balloonangioplasty, stent or filter placement within the last 6 months.

  15. Complete occlusion of the ophthalmic artery.

  16. Pacemaker, Cochlear, or neurostimulation implant.

  17. Presence of cranial aneurysm, clinically significant stenosis in common carotidartery or internal carotid artery, or tortuous vascular anatomy as seen onpre-procedural CT Angiogram that, in the clinical judgement of the investigator,represents an unreasonable risk to perform the intervention.

  18. Condition associated with increased bleeding risk including but not limited to:major surgical procedure or trauma within 30 days of screening; clinicallysignificant gastrointestinal bleeding within 1 year of screening; known gastric orduodenal ulcer; history of intracranial or spinal bleeding; chronic hemorrhagicdisorder; 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.

  19. Treatment with oral anticoagulant medications (e.g., Warfarin / non-vitamin Kanticoagulants [NOACs] exclusionary; aspirin or clopidogrel allowed).

  20. Sustained and uncontrolled hypertension with systolic blood pressure > 180 mmHg.

  21. Diagnosis of moderate to severe symptomatic congestive heart failure (CHF) orchronic obstructive pulmonary disease (COPD)

  22. Diagnosis of connective tissue, demyelinating, autoimmune, or inflammatory diseases (e.g., lupus, rheumatoid arthritis, scleroderma, giant cell arteritis, multiplesclerosis, etc.).

  23. Intolerance of either pre- or post- procedure medication regimen.

  24. Pregnancy, lactation, or plans to become pregnant during participation in thisclinical trial.

  25. Participation in any other non-eye related drug or device clinical trial within 30days prior to enrolling in this study and/or during study participation. Other

  26. Use of facial fillers or paralytic drugs during study participation.

  27. Subject who, in the clinical judgement of the investigator, is not otherwisesuitable for participation in the study for another clinical reason, as documentedby the investigator.

Study Design

Total Participants: 17
Treatment Group(s): 1
Primary Treatment: OPTiC System
Phase:
Study Start date:
February 27, 2023
Estimated Completion Date:
October 01, 2024

Study Description

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

Connect with a study center

  • Buenos Aires Macula

    Buenos Aires,
    Argentina

    Site Not Available

  • CODrC

    Buenos Aires,
    Argentina

    Active - Recruiting

  • ENERI

    Buenos Aires,
    Argentina

    Site Not Available

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