The ShORe trial aims to determine if the investigational medication OPT-302 will improve vision for people with wet age-related macular degeneration (AMD) when given in combination with ranibizumab, compared to ranibizumab alone.
About this study
Age-related macular degeneration (AMD) is an eye condition that can cause blurry vision or dark spots when looking straight ahead. Wet AMD occurs when abnormal blood vessels grow under the macula and retina, a part of the eye that helps to see. The abnormal blood vessels leak blood and fluid, causing problems with vision.
The total amount of time you could be in the study is almost 2 years if you complete all parts of the study. The trial has 3 parts:
- Screening period of 2 weeks to see if you are eligible
- Treatment period of about 1 year and 10 months
- 4-week safety visit after your last dose
Anticipated enrolment close date: TBC
Who can take part
The ShORe Trial might be right for you if you:
- Are male or female aged at least 50 years at the time of informed consent
- Are having symptoms of wet age-related macular degeneration
- Have not yet received any treatment for the wet age-related macular degeneration
- Eye examination
- Scans and photography of the eyes
- Physical examination
- Vital signs
- Blood tests and urine samples
- Study medication
All research in Australia involving human participants is reviewed by an independent group called a Human Research Ethics Committee (HREC). The ethical aspects of this research study have been approved by the Royal Melbourne Hospital HREC.
This study is being carried out according to the National Statement on Ethical Conduct in Human Research (2007). This statement protects the interests of people who agree to participate in human research studies.
The Clinical Trials Centre (CTC) is a dedicated, purpose-built space where we conduct clinical trials.
The CTC is located on Level 2 South. When you arrive, if you are unsure where to go, talk to one of our friendly volunteers or the information desk staff.