The Golden trial is a study of a potential new treatment referred to as ISIS 696844 to determine its safety and effectiveness in slowing the progression of geographic atrophy (GA) caused by age-related macular degeneration (AMD).
About this study
Geographic atrophy (GA) is a late stage of age-related macular degeneration (AMD) and occurs when cells in the retina deteriorate and die, resulting in blind spots in the visual fields.
This trial assesses the safety and efficacy of IONIS-FB-LRx in participants with GA secondary to AMD.
The investigational drug will be administered via subcutaneous injection beneath the skin in abdomen or thigh – not into the eye. Because of this, there is the potential to treat both eyes with just one single injection.
Study duration
The total amount of time you could be in the study is approximately 18 months if you complete all parts of the study. There are three periods to the study:
- Screening period of 14 weeks
- If you are found suitable, a treatment period that occurs over 12 months at the RMH
- Safety period of 2 months
Anticipated enrolment close date: Ongoing
Who can take part
The Golden trial might be right for you if you:
- Are male or female aged at least 50 years at the time of informed consent
- Have geographic atrophy from macular degeneration
- Have decent general health
What's involved
- Eye examination
- Scans and photography of the eyes
- Physical examination
- Vital signs and ECGs
- Blood tests and urine samples
- Questionnaire
- Study medication (subcutaneous/under the skin injections into the stomach area or thigh)
- Meningococcal vaccines and pneumococcal vaccine(s) if none in past 3 years
Ethics
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.