AuthorisedTherapeutic exploratory (Phase II)Interventional

Antisense Oligonucleotide Eye Drops against IRS-1 to Optimize Pretransplant Lymphangio-regression Prior to High-Risk Keratoplasty (Olisens-Precon)

This study, called 'Olisens-Precon,' is looking for adults whose corneas (the clear front part of the eye) have abnormal blood vessels, often due to an infection like herpes. These patients are preparing for a 'high-risk' cornea transplant. The main goal is to test new eye drops, OLISENS, which are designed to reduce these abnormal blood vessels before the transplant. Researchers will compare OLISENS with existing treatments and a dummy eye drop (placebo) to see if it's safe and effective in shrinking these vessels. This is a Phase II study, meaning it's an early-stage trial exploring if the new treatment works and is safe. The hope is that reducing these vessels can make the cornea transplant more successful.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

University Of Cologne

Enrolment target

Start

28 Jan 2026

Pathologically prevascularized corneas due to herpetic keratopathy prior to “high-risk” corneal transplantation (keratoplasty)

What is this study about?

Imagine the front clear part of your eye, called the cornea, like a window. Sometimes, after an infection or injury, tiny, abnormal blood vessels can grow into this window. This is called a 'prevascularized cornea.' If you need a cornea transplant when these vessels are present, it's considered a 'high-risk' transplant because the chances of the body rejecting the new cornea are higher. This study is for people who have this kind of eye damage, often from conditions like a herpes infection, and are getting ready for a cornea transplant.

The main idea behind this study is to see if new eye drops, called OLISENS, can help shrink these abnormal blood vessels before you have your transplant. The researchers believe that by reducing these vessels, the new cornea might have a better chance of being accepted by your body and working well. You might also receive other eye drops like Floxal EDO or Dexa EDO, or a placebo (a dummy eye drop that looks just like OLISENS but contains no active medicine).

This is a Phase II study, which means it’s an early step in testing a new medicine. The doctors want to find out if OLISENS is safe and if it starts to work as expected. They will carefully measure the amount of abnormal blood vessels in your eye and also check your vision, eye pressure, and comfort, to see if the new drops make a difference, and to ensure they are well-tolerated. Your participation would help doctors understand if this new approach could improve outcomes for future patients undergoing cornea transplants.

Key takeaways

This study tests new eye drops (OLISENS) for specific eye damage.
It aims to reduce abnormal blood vessels before a high-risk cornea transplant.
Participation involves using eye drops and regular eye checks.
Some people will receive OLISENS, others standard treatments, or a placebo.
It's a Phase II study, focusing on safety and initial effectiveness.

Who may be eligible?

This study is for adults, men and women, who are at least 18 years old. There is no upper age limit.

To be eligible, you must have specific damage to the clear front part of your eye, called the cornea. This damage would involve new, abnormal blood vessels growing in the cornea, often because of an infection like the herpes virus. Crucially, you must also be preparing to have a 'high-risk' cornea transplant.

Your eye doctor will need to confirm that you meet all the specific requirements for the study. For example, they will check your overall eye health and medical history to make sure the study treatments would be suitable and safe for you.

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.

Are you an adult aged 18 or over?
Do you have abnormal blood vessels on the clear front part of your eye (cornea)?
Is this due to a condition like a herpes infection?
Are you scheduled for a 'high-risk' cornea transplant?
Are you able to attend regular clinic appointments?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be given specific eye drops to use. These could be the new OLISENS drops, existing standard drops like Floxal EDO or Dexa EDO, or a placebo (a dummy drop that looks the same as OLISENS but has no active ingredient). You would use these drops regularly as instructed by your study team. You would also have regular appointments at the clinic to check on your eye health and see how the treatment is working.

During these appointments, the study team will take detailed measurements of your eye. This includes pictures of your cornea to track the blood vessels, tests to check your vision, measurements of your eye pressure, and assessments of how your eye feels. They might also check your overall quality of life using questionnaires. You would need to keep records of your daily use of the eye drops and any other medications you take.

The full duration of your participation would depend on the study plan, which your doctor will explain in detail. It involves various tests and follow-up visits, and you would be expected to attend all scheduled appointments.

Potential risks and benefits

Taking part in a study like this might offer some potential benefits, such as receiving close medical attention and access to a new treatment that isn’t yet widely available, which might improve the success of your cornea transplant. However, there are also potential risks involved. The eye drops could cause side effects, even if they are known to be safe in general. The placebo drops contain no active medicine, so they would not directly help your condition. You will be told about all known or potential side effects and risks before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Germany

Common questions

What is a 'high-risk' cornea transplant?

It means there's a higher chance your body might reject the new cornea, often because of abnormal blood vessels in your eye before the surgery.

What are OLISENS eye drops?

OLISENS are new eye drops being tested to see if they can reduce abnormal blood vessels in your eye before a cornea transplant.

What is a placebo eye drop?

A placebo is a dummy eye drop that looks exactly like the real medicine but doesn't contain any active ingredients. It helps study doctors compare results accurately.

Will I know if I'm getting the new drops or a placebo?

No, in this type of study, neither you nor your study doctor will know who is getting which treatment. This helps ensure fair and unbiased results.

How long will I be in the study?

Your study doctor will explain the exact timeframe, which will involve regular visits and using the eye drops for a set period before and after your transplant.