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Safety, tolerability and exploratory efficacy of PST-611 in patients with geographic atrophy secondary to age-related macular degeneration

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What is this trial about?

A plain-language summary of the goals, design and what participants do

The study looks at people who have Geographic atrophy secondary to age-related macular degeneration, a condition where the central part of the retina slowly breaks down and vision becomes blurry or missing. The medication being tested is called PST-611, which is given as a small injection directly into the eye. The main goal of the trial is to find out whether repeated doses of this drug are safe and can be tolerated by the eyes.

Participants will receive several injections over a period of time and will attend regular visits where doctors will check the eyes for any side effects. During these visits the eyes will be examined with tools such as a slit lamp biomicroscopy and a dilated ophthalmoscopy to look at the front and back of the eye, and the pressure inside the eye (intraocular pressure) will be measured. Images of the retina will be taken using spectral domain-optical coherence tomography, color fundus photography, and tests of how well the person can see details and contrasts, including a measurement of contrast sensitivity function and an assessment of best corrected visual acuity.

Throughout the study doctors will record any eye problems or other health events, watch how the retina changes, and note any differences in vision quality. The information gathered will help determine if the drug can be used safely and if it shows any early signs of helping to preserve vision in this condition.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Baseline visit and initial assessments
After signing the consent form, you will attend a baseline visit where the study team will perform a series of eye examinations.
These examinations include a slit lamp biomicroscopy (a microscope that lets the doctor look at the front part of the eye), dilated ophthalmoscopy (examining the back of the eye after the pupils are widened), measurement of intraocular pressure (the fluid pressure inside the eye), best corrected visual acuity (a test of how well you can see with glasses or contacts), color fundus photography (photos of the back of the eye), and spectral domain‑optical coherence tomography (sd‑oct, a detailed scan of the retinal layers).
The purpose of these tests is to record the condition of your eye before any study medication is given.
Step 2
First intraocular injection of pst‑611
You will receive the first dose of pst‑611 as an intraocular injection (a tiny amount of medication placed directly into the eye).
The dose is 00 µg (micrograms) of the solution for injection.
The injection is administered by a qualified eye specialist in a sterile setting.
Step 3
Post‑injection observation
After the injection, you will be observed for a short period (usually about 30 minutes) to ensure there are no immediate reactions such as discomfort, vision changes, or signs of infection.
Step 4
Scheduled follow‑up visits and safety monitoring
You will return for regular follow‑up visits according to the study schedule. at each visit the same set of eye examinations performed at baseline will be repeated to monitor any changes.
The examinations include slit lamp biomicroscopy, dilated ophthalmoscopy, intraocular pressure measurement, best corrected visual acuity testing, color fundus photography, and sd‑oct imaging.
The study team will also ask about any ocular adverse events (eye‑related side effects) or other health problems that may have occurred since the last visit.
Step 5
Additional intraocular injections of pst‑611
Based on the study protocol, you will receive additional intraocular injections of pst‑611 at predetermined intervals (multiple doses). each injection uses the same dose of 00 µg.
The exact timing of each injection will be explained by the study team, and the injections will continue until the end of the trial period.
Step 6
Final assessment at study completion
At the end of the study (approximately June 2028), a final comprehensive eye examination will be performed using the same tests as earlier visits.
The final visit will also include a review of all safety information collected during the trial to determine the overall tolerability of the medication.

Who can join the trial?

9 criteria

Must sign a written consent form and be able to attend study visits and follow the study instructions.
Must be 65 years of age or older, regardless of gender.
In the eye that will be studied, there must be a condition called cRORA (complete retinal outer layer atrophy) seen on an eye scan called OCT. This means a dark area at least 250 µm wide, loss of the RPE (a thin layer that supports the retina), damage to the light‑sensing cells called photoreceptors, and no signs of a torn RPE.
The eyes must be able to stay steady enough for imaging and tests, whether looking straight ahead or slightly off‑center, as judged by the doctor.
Must be covered by social security insurance if required by local regulations.
Must have a recent (within the past 3‑12 months) growth of the GA lesion in the study eye of at least 1.6 mm² per year.
The GA lesion size in the study eye must be between 1.25 mm² and 16 mm² when measured by OCT. If there is nearby damage near the optic nerve (peripapillary atrophy), the GA lesion must be separate and not expected to merge with it during the study.
If both eyes meet the requirements, the doctor will choose which eye to treat based on overall evaluation, such as how fast the lesion is growing and how easy it is to give the treatment.
The best‑corrected vision in the study eye, measured with a standard eye chart (BCVA), must be 75 letters or fewer on the ETDRS chart (equivalent to 20/32 or worse on the Snellen chart).

Who cannot join the trial?

15 criteria

Any active eye infection or inflammation (such as infected eyelid, infected pink eye, cornea infection, inflammation of the white of the eye, or severe inner‑eye infection) now or within the past 12 weeks (84 days).
Uncontrolled eye pressure of ≥ 25 mmHg in the study eye at the screening visit (intraocular pressure means the fluid pressure inside the eye).
Very low eye pressure of < 6 mmHg in the study eye that could interfere with the treatment (intraocular hypotension means abnormally low pressure inside the eye).
History of conditions such as scleritis, thinning of the white part of the eye, severe eye allergies, severe surface disease, scarring, or any implanted device inside the eye that could affect the treatment.
Any other eye problem, including any retinal disease other than age‑related macular degeneration, that the doctor feels could be unsafe or affect the study results.
Previous exposure to any gene therapy product other than the non‑viral gene therapy being studied (gene therapy is a treatment that alters genetic material).
Being legally incapacitated or having limited legal capacity according to French law.
Any health condition that the doctor believes could compromise safety or the ability to follow the study protocol.
Known or suspected allergy to any standard eye drops, local anesthetics, or other medicines used during the PST‑611 administration (hypersensitivity means an allergic reaction).
Use of other experimental medicines within the past 12 weeks (84 days).
Inability to read and understand French well enough to give written informed consent in French.
Any eye surgery (including cataract surgery) or steroid injection around the eye in the past 12 weeks (84 days).
Needing more than two anti‑VEGF injections per year, or having an anti‑VEGF injection within 3 months before the first dose, and the lesion must be inactive (anti‑VEGF drugs block the growth of abnormal blood vessels in the eye).
Cloudiness or other opacity in the eye that blocks detailed imaging or is likely to require surgery during the study (media opacity means something that makes it difficult to see inside the eye).
History of glaucoma filtering surgery (such as trabeculectomy or a shunt implant) or any eye surgery in the past 12 weeks (84 days).

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Verified sites

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Assistance Publique Hopitaux De Paris
Paris, France
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CHU Grenoble Alpes
La Tronche, France

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Investigated drugs

PST-611 is an experimental medicine that is injected directly into the eye. In this study it is being given to people who have geographic atrophy, a type of damage that can happen in age‑related macular degeneration. The medicine is a clear liquid (solution) meant to be placed inside the eye with a small needle. Researchers are looking at how safe it is, how well patients can tolerate it, and whether it might help slow or improve the eye damage.

What is already known about the treatment

PST-611 - PST-611 is given as a sterile liquid that is injected directly into the eye (intra‑ocular solution for injection). It is still an experimental drug being studied in clinical trials and has not yet received market approval. The medicine is being tested for use in people with geographic atrophy caused by age‑related macular degeneration, a condition that leads to loss of vision. It works by blocking a part of the immune system called the complement pathway, which helps protect the cells in the retina from damage; it is classified as an investigational complement inhibitor for eye disease.

Investigated diseases

Geographic atrophy secondary to age-related macular degeneration - Geographic atrophy is a condition where the thin layer of cells at the back of the eye slowly thins and forms patches of missing tissue. These patches grow larger over months to years, leading to a gradual loss of sharp central vision. As the disease advances, the blind spots expand, making tasks such as reading and recognizing faces increasingly difficult.