None listed
Conditions
Brief summary
The main objective of this study is to evaluate the safety and feasibility of the OcuDyne Ophthalmic Micro Balloon Angioplasty System in subjects with dry age-related macular degeneration (AMD). Currently there is no treatment available for dry AMD and this device system may offer a potentially effective treatment. The study is first in human and is a prospective, open label, feasibility clinical trial. This multi-center trial will be conducted at up to six sites in Australia and aims to enroll and treat up to 30 subjects. This study involves a 60 day screening period, study procedure, overnight observation, and follow-up visits (Day 2, Week 1, Week 4, Months 3, Months 6). The study duration for each participant is approximately 8 months. The feasibility of the procedure is presented due to the historically successful use of small artery cerebral angioplasty and ophthalmic artery (OA) angioplasty for acute ischemic retinopathy using like instrumentation. The OcuDyne #OC-1901 project is an effort to confirm the feasibility of establishing the presence of OA ostium narrowing intraoperatively and further, to establish the ability to treat the condition of dry AMD.
Interventions
Primary study objective is to evaluate the safety and feasibility of the OcuDyne Ophthalmic Micro Balloon Angioplasty System in subjects with nonexudative age-related macular degeneration.
This study is being conducted to test a new interventional micro balloon angioplasty procedure to increase choroidal blood supply. The feasibility of the procedure is presented due to the historically successful use of small artery cerebral angioplasty and ophthalmic artery (OA) angioplasty for acute ischemic
Primary study objective is to evaluate the safety and feasibility of the OcuDyne Ophthalmic Micro Balloon Angioplasty System in subjects with nonexudative age-related macular degeneration. This study is being conducted to test a new interventional micro balloon angioplasty procedure to increase choroidal blood supply. The feasibility of the procedure is presented due to the historically successful use of small artery cerebral angioplasty and ophthalmic artery (OA) angioplasty for acute ischemic retinopathy using like instrumentation. The OcuDyne #OC-1901 project is an effort to confirm the safety and feasibility of reaching and treating the target anatomy to treat the condition Age-related macular degeneration (AMD) with specialty devices made for this purpose. Device intervention (Ocudyne Ophthalmic Micro Balloon Angioplasty System) will be utilized in the OcuDyne #OC-1901 project. The system is composed of the following components: Aiming Microcatheter (AMC); Over the Wire (OTW) Aiming Microcatheter (AMC); Rapid Exchange (RX) Micro Balloon Catheter (MBC); Rapid Exchange (RX) The angioplasty procedure is expected to take approximately 30 - 60 minutes and is performed by neuro-interventionists that have extensive experience performing endovascular procedures. The study procedure is conducted in a neurovascular imaging suite under fluoroscopic visualization by inserting (via percutanious femoral access), utilizing commercially available and commonly used (for this purpose) devices to access the arteries. The study doctor accesses the area near the ophthalmic artery, the OcuDyne Ophthalmic Micro Balloon Angioplasty System will be used to enter the ophthalmic artery. One device (Aiming Micro Catheter) helps access the artery (Investigator choice of two common styles of like devices: Over the Wire (OTW) or Rapid Exchange (RX)); the second device (Micro Balloon Catheter - Investigator choice of size based on subject anatomy) is a wire with a tiny inflatable balloon at the end that is placed in the entrance of the ophthalmic artery. As the balloon is inflated, the blood vessel is opened. The details and information produced as part of this project will be careful documented and collected to analyze. All information will be continually monitored and audited throughout the study to ensure accuracy and subject safety.
Sponsors
OcuDyne Australia Pty Ltd
Study design
Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
60 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed