CERA

Science and Research

A Clinical Study to Evaluate the Safety and Feasibility of the Ocudyne System in the Treatment of Age-Related Macular Degeneration (AMD)

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).

Overview

Currently, there is no treatment available for dry AMD and this device system may offer a potentially effective treatment. The study is first in humans and is a prospective, open-label, feasibility clinical trial. This multi-centre trial will be conducted at up to six sites in Australia and aims to enrol and treat up to 30 subjects. This study involves a 60-day screening period, study procedure (performed at Monash Health), overnight observation, and follow-up visits (day 2, week 1, week 4, month 3, month 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.For further information about this study please contact the Macular Research Unit on (03) 9929 8113 or email [email protected]
  • Principal Investigator
Associate Professor Penelope Allen

Learn more

View this study on the ANZCTR

See the Australian New Zealand Clinical Trials Registry listing for more detailed information about this study.