Study on the Effectiveness and Safety of STN1010904 Eye Drops for Patients with Fuchs Endothelial Corneal Dystrophy

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What is this study about?

This clinical trial is focused on studying a condition called Fuchs Endothelial Corneal Dystrophy (FECD), which affects the cornea, the clear front part of the eye. The study is testing a new treatment called STN1010904, which is an eye drop containing the active substance sirolimus. Sirolimus is a chemical that may help improve the condition of the cornea in people with FECD. The trial will compare two different concentrations of these eye drops, 0.03% and 0.1%, to see how effective and safe they are compared to a placebo.

The purpose of the study is to assess how well the STN1010904 eye drops work in improving vision and the health of the cornea in people with Fuchs Endothelial Corneal Dystrophy. Participants in the study will use the eye drops twice a day. The study will last for about 18 months, during which time participants will have regular check-ups to monitor their vision and eye health. These check-ups will include tests to measure vision clarity and sensitivity to light, as well as examinations of the eye using special equipment.

Throughout the study, the safety of the STN1010904 eye drops will be closely monitored. This will involve checking for any side effects and conducting various eye examinations, such as looking at the eye with a special microscope and measuring the pressure inside the eye. The study aims to provide valuable information on whether these eye drops can be a beneficial treatment option for people with Fuchs Endothelial Corneal Dystrophy.

1 initial visit

Upon joining the study, the initial visit involves a comprehensive eye examination to confirm the diagnosis of Fuchs Endothelial Corneal Dystrophy (FECD).

Eligibility is determined based on specific criteria, including age, visual acuity, and corneal characteristics.

2 randomization

Participants are randomly assigned to receive either the STN1010904 ophthalmic suspension or a placebo.

The study uses a double-masked approach, meaning neither the participant nor the study team knows which treatment is being administered.

3 treatment phase

Participants administer the assigned eye drops twice daily.

The STN1010904 is available in two concentrations: 0.03% and 0.1%.

4 follow-up visits

Regular follow-up visits are scheduled to monitor the participant’s eye health and response to treatment.

These visits include assessments of visual acuity, contrast sensitivity, and other eye health indicators.

5 end of study evaluation

At the conclusion of the study, a final evaluation is conducted to assess changes in visual acuity and other key measures.

Safety assessments are also performed to identify any adverse effects from the treatment.

Who Can Join the Study?

Must be a male or female between 30 to 75 years old.
Must have a diagnosis of Fuchs Endothelial Corneal Dystrophy (FECD), which is a condition affecting the cornea of the eye.
Must provide signed informed consent, which means agreeing to participate after understanding the study details.
Must have a best-corrected visual acuity (BCVA) of +0.2 LogMAR or better in the study eye. This means the vision should be at least as good as 20/32 on a standard eye chart.
Must have a grade of 3 to 5 on the Modified Krachmer scale in the study eye. This scale is used to assess the severity of the condition in the cornea.
Must have at least two out of three specific tomographic features in the study eye, which are special measurements of the cornea:
- Loss of parallel isopachs: The layers of the cornea are not evenly shaped.
- Displacement of the thinnest point of the cornea: The thinnest part of the cornea is not in the usual position.
- Focal posterior corneal depression: A small area of the cornea is lower than expected.
Must have visible endothelial cells in more than 50% of the area in at least one image taken by a special camera called noncontact specular microscopy. These cells are important for keeping the cornea clear.

Who Cannot Join the Study?

Patients who do not have a diagnosis of Fuchs Endothelial Corneal Dystrophy (FECD) cannot participate. This is a condition affecting the clear front part of the eye called the cornea.
Patients who are not within the specified age range for the study cannot participate. The age range is not specified here, but it is important for eligibility.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.
Patients who do not meet other specific health criteria set by the study cannot participate. These criteria are not detailed here but are important for safety and accuracy.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Fondation A De Rothschild	Paris	France
Ivcpddnh dq Cbfqdekjcxtj Hmkirdrqaai Uzprlkkinozfi db Spcbj Ezlkjch (wljvqen	Saint Priest En Jarez	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	08.06.2023

Trial locations

Investigated drugs:

Sirolimus

STN1010904 is an ophthalmic suspension being tested in this clinical trial. It is designed to help treat Fuchs Endothelial Corneal Dystrophy (FECD), a condition affecting the cornea of the eye. The study is evaluating the effectiveness and safety of this medication when used twice daily. The trial is comparing two different concentrations of the suspension to see how well they work in improving the condition of patients with FECD.

Fuchs Endothelial Corneal Dystrophy – This is a progressive eye disease that affects the cornea, the clear front surface of the eye. It is characterized by the gradual loss of endothelial cells, which are responsible for maintaining the cornea’s clarity by pumping out excess fluid. As these cells deteriorate, fluid builds up in the cornea, leading to swelling and clouding of vision. Over time, individuals may experience blurred vision, glare, and difficulty seeing in low light conditions. The disease typically progresses slowly, with symptoms often becoming noticeable in middle age or later.

Trial ID:

2024-517104-11-00

Protocol code:

101090401IN

NCT ID:

NCT05376176

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of STN1010904 Eye Drops for Patients with Fuchs Endothelial Corneal Dystrophy

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?