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

Abstract

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.