A clinical study to evaluate the safety and feasibility of the OcuDyne system in the treatment of age-related macular degeneration (AMD)

OcuDyne Australia Pty Ltd0 sites6 target enrollmentSeptember 26, 2019

Overview

No summary available.

Registry

who.int

Start Date

September 26, 2019

End Date

April 13, 2024

Last Updated

last year

Study Type

Interventional

Sex

All

Sponsor

OcuDyne Australia Pty Ltd

•1\. Adults at least 60 years of age at the time of consent
•2\. 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
•3\. ETDRS BCDVA letter score of between 55 and 20 letters (Snellen equivalent of 20/80 to 20/400\) in the study eye, which in the Investigator’s judgment is caused by non\-exudative AMD

•1\.Any surgical intraocular treatment (including laser) within 3 months in the study eye.
•2\.History of exudative AMD or Anti\-Vascular Endothelial Growth Factor (anti\-VEGF) injections in the study eye.
•3\.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.).
•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, anterior ischemic optic neuropathy (AION) or non\-arteritic anterior ischemic optic neuropathy (NAION) in the study eye.
•8\.Myopia \> 6\.0 Diopters (D) or Axial Length equal to or greater than 26\.0 mm in the study 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 eye within 90 days prior to enrolling in this study and/or during study participation.