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

Not Applicable

• Conditions: Dry Age-Related Macular Degeneration; Eye - Diseases / disorders of the eye

• Registration Number: ACTRN12619001315101
• Lead Sponsor: OcuDyne Australia Pty Ltd

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2019-09-26
• Study Completion: 2024-04-13
• Last Update Posted: 6 May 2024

Recruitment & Eligibility

• Status: Stopped early
• Sex: All
• Target Recruitment: 6

Inclusion Criteria

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

Exclusion Criteria

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.
11.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.).
12.Previous stroke, including ischemic, hemorrhagic or transient ischemic attack (TIA).
13.Previous myocardial infarction (MI), including ST segment elevation (STEMI), non-ST segment elevation (NSTEMI) or coronary spasm/angina.
14.Coronary or other intravascular percutaneous procedure, including balloon angioplasty, stent or filter placement within 6 months.
15.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.
16.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.
17.Sustained and uncontrolled hypertension with systolic blood pressure > 180 mmHg.
18.Diagnosis of moderate to severe symptomatic chronic heart failure (CHF) or chronic obstructive pulmonary disease (COPD)
19.Diagnosis of connective tissue disease (e.g., lupus, rheumatoid arthritis, scleroderma, etc.).
20.Intolerance of either pre- or post- procedure medication regimen.
21.Pregnancy, lactation, or plans to become pregnant during participation in this clinical trial.
22.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.
23.Use of facial fillers or paralytic drugs during study participation.

Study & Design

• Study Type: Interventional
• Study Design: Not specified