In short
PST-611 is an investigational substance being studied for geographic atrophy secondary to age-related macular degeneration. One Phase 2 clinical trial is currently authorised in the EU, planning to enrol 24 participants. The trial will test the safety and tolerability of multiple doses of PST-611 given by intraocular injection.
Key points
- PST-611 is an investigational substance with no marketing authorisation.
- It is being studied in geographic atrophy secondary to age-related macular degeneration.
- The single authorised trial is Phase 2 and plans to enrol 24 participants.
- PST-611 is given as an intraocular injection.
- The trial is open-label, meaning all participants receive the active substance.
- The main goal is to measure safety and tolerability of multiple doses.
What is PST-611?
PST-611 is an investigational substance being developed for the treatment of geographic atrophy secondary to age-related macular degeneration. It has no marketing authorisation and is not yet approved as a medicine. The name PST-611 is a development code used to identify the substance in clinical research.
How does PST-611 work?
The mechanism of action of PST-611 is not described in the available trial registry data. The trial record focuses on evaluating the safety and tolerability of the substance rather than explaining how it acts in the body.
Which conditions is PST-611 studied for?
- Geographic atrophy secondary to age-related macular degeneration — an advanced form of age-related macular degeneration in which areas of the retina thin and lose function, leading to progressive vision loss.
How is PST-611 given?
PST-611 is given by intraocular injection, meaning it is injected directly into the eye. The trial record lists the dose as 00 micrograms, which indicates that the dose was not reported in the registry. The trial is designed to evaluate multiple doses of the substance.
What do the clinical trials show?
One clinical trial of PST-611 is currently authorised in the EU Clinical Trials Information System. It is a Phase 2, open-label trial, meaning that all participants know they are receiving PST-611 and there is no placebo control. The trial plans to enrol 24 participants with geographic atrophy secondary to age-related macular degeneration.
The trial is designed as a multiple dose study to evaluate safety and tolerability, with exploratory efficacy as a secondary goal. The primary outcomes include the frequency and severity of ocular adverse events and treatment-emergent adverse events, including serious adverse events. Investigators will also assess findings from ophthalmic examinations, including slit lamp biomicroscopy, dilated ophthalmoscopy, intraocular pressure, best corrected visual acuity, colour fundus photography and spectral domain optical coherence tomography.
The trial is currently in the Authorised status, meaning it has received regulatory approval to proceed but has not yet reported results.
What side effects are known?
No side effect data are available from the registry record. The trial is specifically designed to collect information on ocular adverse events and treatment-emergent adverse events, including serious adverse events. Results will only be known once the trial has been completed and analysed.