An open-label multiple dose safety, tolerability and exploratory efficacy clinical trial of PST-611 in patients with geographic atrophy secondary to age-related macular degeneration
Age-related macular degeneration (AMD) is a common eye condition that affects central vision. Geographic atrophy is an advanced stage of dry AMD where light-sensitive cells in the retina slowly waste away. This causes blind spots and makes everyday tasks like reading or recognising faces very difficult. Currently, there are few treatment options available in the UK. This phase 2 trial is investigating a new experimental medicine called PST-611. The main goal is to see if multiple doses of PST-611 are safe and well tolerated in the eye. Researchers will also use detailed eye scans and vision tests to see if the medicine can slow down the loss of retinal cells. This is an open-label trial, which means all participants will receive the active study medicine rather than a dummy treatment.
At a glance
What is this study about?
Age-related macular degeneration (AMD) affects the macula, the small central area of the retina at the back of the eye responsible for sharp, detailed vision. Geographic atrophy is a late form of dry AMD. Over time, patches of cells in the macula thin and break down, creating permanent gaps in your central vision. Because this damage is currently irreversible, researchers are urgently searching for treatments that can protect these delicate eye cells.
This clinical trial is evaluating an experimental drug known as PST-611. It is a Phase 2 exploratory study, which means scientists have already completed initial safety checks and are now looking at how the eye responds to several doses over time. The study aims to confirm whether the treatment is safe, check for any unwanted side effects, and see if it can help preserve retinal tissue.
Throughout the study, doctors will monitor your eyes using standard eye tests and advanced camera scans. These include slit-lamp examinations (using a special microscope to view the eye), eye pressure measurements, and optical coherence tomography (OCT), which takes 3D pictures of the layers inside your retina. Special computer tools will measure whether the medicine slows the rate at which retinal cells wear away.
While this study is an early investigation and cannot promise direct improvement to your sight, the findings are essential for understanding whether PST-611 could become a valuable future treatment for people living with dry AMD.
Key takeaways
- Tests an experimental drug called PST-611 for geographic atrophy (advanced dry AMD).
- Aims to check the safety, tolerability, and early effectiveness of multiple doses.
- Open-label design means all participants receive the active study treatment.
- Involves regular eye examinations, vision tests, and painless retinal imaging scans.
- Participation is entirely voluntary and will not affect your standard NHS care.
Who may be eligible?
This study is open to adults diagnosed with geographic atrophy caused by age-related macular degeneration (dry AMD). Both men and women are eligible to be considered.
To take part, an eye specialist must confirm that your vision changes are due to geographic atrophy and not another condition, such as wet AMD (which involves abnormal, leaking blood vessels) or another serious eye disease. Your overall health and medical history will also be reviewed to ensure the trial is safe for you.
You must be able and willing to attend all scheduled hospital appointments for eye checks, treatments, and imaging scans throughout the study period.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- You have been diagnosed with geographic atrophy secondary to dry AMD.
- You do not have wet AMD or other major untreated eye diseases.
- You are able to travel to a specialist clinic for regular appointments.
- You can tolerate standard eye drops used to widen your pupils.
- You are willing to complete regular vision checks and eye scans.
What does participation involve?
If you join the trial, you will attend regular appointments at a specialist eye clinic. During your visits, the medical team will give you the study medicine, PST-611, and perform thorough eye assessments. These checks include reading letters on an eye chart, measuring the fluid pressure inside your eyes, and using dilating eye drops so the doctor can examine the back of your eye. You will also have painless, non-invasive digital photographs and 3D scans of your retina. Because this is a multiple-dose study, you will return for several clinic visits over a number of months to monitor your eye health and check for any side effects.
Potential risks and benefits
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Common questions
What is geographic atrophy?
It is an advanced form of dry age-related macular degeneration (AMD) where areas of light-sensitive cells in the central retina wear away, leading to blind spots and loss of central vision.
Will I definitely receive the study medicine?
Yes. This trial is 'open-label', meaning there is no placebo (dummy medicine). Everyone who takes part receives the active study drug, PST-611.
Are the eye scans painful?
No. The scans, such as optical coherence tomography (OCT) and retinal photography, are completely non-invasive and painless, similar to having a photograph taken.
Will taking part cost me anything?
No. The study drug and all trial-related tests are provided free of charge. Clinical trials also often offer help with reasonable travel and parking costs.
Can I leave the study if I change my mind?
Yes. You can withdraw from the study at any point. Your decision will have no impact on the standard of care you receive from the NHS.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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