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AutorizadoExploratório terapêutico (Fase II)Intervencionista

Antisense Oligonucleotide Eye Drops Against IRS-1 to Treat Pathological Corneal Neovascularisation in Aniridia-Associated Keratopathy (Olisens-Aniridia)

This research is looking into a new eye drop treatment, called OLISENS, for individuals who have a specific eye problem linked to a condition called aniridia. Aniridia is a rare eye disorder that leaves people with undeveloped or missing irises, the coloured part of the eye. This can lead to other issues, including the growth of new, unwanted blood vessels over the cornea, which is the clear front surface of the eye. These blood vessels can cause problems with vision. The study aims to see if these new eye drops can help shrink these abnormal blood vessels and improve eye health for people affected by this condition. It's an important step in exploring new ways to manage this complex eye problem.

Em resumo

Status
Autorizado
Fase
Exploratório terapêutico (Fase II)
Patrocinador
University Of Cologne
Meta de inscrição
20
Iniciar
23 Jan 2026

Sobre o que é este estudo?

This study is about exploring a new way to treat an eye problem called corneal neovascularisation, which happens to some people with a rare eye condition called aniridia. Aniridia means you're born with part or all of the coloured part of your eye (the iris) missing or underdeveloped. This can lead to various eye issues, and one of them is when new, unwanted blood vessels grow over the cornea, the clear 'window' at the front of your eye.

These new blood vessels can make your vision blurry, cause pain, and lead to other complications. Current treatments aren't always effective, so researchers are trying to find better options. This study is testing special eye drops, called OLISENS, which are designed to target and reduce these abnormal blood vessels.

The main goal is to see if the OLISENS eye drops can shrink the area covered by these new blood vessels. They will also look at how vision changes, if the eye feels more comfortable, and other health markers. This is an early-stage study (Phase II), meaning it's one of the first times these drops are being tested in a larger group of people to see if they are safe and effective.

Pontos principais

  • This study is testing new eye drops (OLISENS) for people with aniridia-related corneal blood vessel growth.
  • The main goal is to see if these drops can shrink the unwanted blood vessels in the eye.
  • It's an early-stage study, exploring the safety and effectiveness of the new treatment.
  • Participation involves regular eye check-ups, vision tests, and using the eye drops as instructed.
  • You must be 18 or older and have corneal neovascularisation linked to aniridia to be considered.

Quem pode ser elegível?

To be considered for this study, you need to be at least 18 years old. Both men and women can take part.

More specific details about your eye health and other medical conditions would be discussed with the study team. Generally, you would need to have corneal neovascularisation related to aniridia, as this is what the treatment is designed for.

There might be certain health conditions or medicines that would prevent you from joining, as the researchers need to make sure the study is safe for everyone involved and that the results are clear. Your doctor or the study team would go through all these details with you.

Este estudo pode ser adequado para você?

Responda a estas perguntas rápidas para ver se você pode ser elegível. Este é apenas um guia — a decisão final é da equipe de pesquisa.

  1. Você tem 18 anos ou mais?
  2. Do you have aniridia?
  3. Have you been told you have corneal neovascularisation (new blood vessels on your cornea)?
  4. Are you willing and able to attend regular clinic visits?
  5. Are you able to use eye drops as directed?
Responda a todas as perguntas para ver o seu resultado.

O que envolve a participação?

If you join this study, you would use the OLISENS eye drops as instructed. The study involves regular visits to the clinic where the medical team will closely monitor your eyes. They will take detailed pictures of your cornea to measure changes in the blood vessels.

Other assessments will include eye tests to check your vision (both in normal light and with glare), questionnaires about your quality of life and eye pain, and measurements of your eye pressure, corneal thickness, and eye surface health. They will also check for any signs of infection or other eye problems.

The study involves ongoing check-ups for a certain period to see how the drops are working and to monitor your general eye health. The exact number of visits and the full duration of the study would be explained in detail by the study staff.

Riscos e benefícios potenciais

Participating in this study might offer a potential benefit of reducing the abnormal blood vessels in your eye and potentially improving your vision and comfort if the new eye drops are effective. However, as with any new medicine, there's always a chance of side effects or that the treatment might not work for you. Potential risks could include irritation, discomfort, or other unexpected reactions to the eye drops. The research team will carefully monitor you for any side effects. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

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Perguntas frequentes

What is aniridia?

Aniridia is a rare eye condition present from birth where the iris (the coloured part of the eye) is missing or not fully developed.

What is corneal neovascularisation?

This is when new, unwanted blood vessels grow over the clear front surface of your eye (the cornea), which can affect your vision.

What kind of eye drops are being tested?

The study is testing new eye drops called OLISENS. They are specifically designed to target and help reduce these abnormal blood vessels.

Will I get the real drug or a dummy treatment?

The information provided doesn't specify if there's a dummy treatment (placebo) arm. This is a question you should ask the study team.

Quanto tempo durará o estudo se eu participar?

The total duration of the study, including all visits and follow-ups, would be explained in detail by the research team.

Como saber mais

Sempre consulte seu médico ou especialista antes de decidir participar de um estudo.

Discussão

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