OcuDyne System in the Treatment of AMD

NCT05091476 | Completed DMC

• 1 other identifier: OC-1901AR
• Study Type: interventional
• Target: 17
• Locations: 1 country
• Sites: 2

Brief Summary

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

Conditions

Age-Related Macular Degeneration

Outcome Measures

Primary Outcomes (1)

• Adverse Events

  Procedural Complications \& Adverse Events

  Intraoperative through Week 4 postoperative

Study Arms (2)

Eyes treated with the OPTiC System

EXPERIMENTAL

Eyes that OPTiC System treatment has been completed

Device: OPTiC System

Fellow Eye

NO INTERVENTION

Contralateral comparator

Interventions

OPTiC System DEVICE

OPTiC System procedure

Eyes treated with the OPTiC System

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• OcuDyne, Inc.: lead

Study Sites (2)

Buenos Aires Macula

Buenos Aires, Argentina

Location

ENERI

Buenos Aires, Argentina

Location

MeSH Terms

Conditions

Macular Degeneration

Condition Hierarchy (Ancestors)

Retinal Degeneration; Retinal Diseases; Eye Diseases

Study Officials

• Luana R Wilbur, BS

  OcuDyne VP, Clinical and Regulatory Affairs

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 12, 2021
• First Posted: October 25, 2021
• Study Start: February 27, 2023
• Primary Completion: July 31, 2024
• Study Completion: October 1, 2024
• Last Updated: February 13, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

AR (2)