Ongoing, recruitingHuman Pharmacology (Phase I)- First administration to humansInterventional

Safety and Tolerability of a Timolol Releasing Intraocular Implant in Subjects With Primary Open-angle Glaucoma

This study is investigating a new way to treat glaucoma, a common eye condition that can damage your eyesight. Researchers are testing a small implant that goes into the eye and slowly releases a medicine called timolol. The main goal of this early-stage study is to check how safe this implant is and whether people can use it without too many problems. This is the very first time this implant will be given to people, so the focus is on understanding its basic effects and if it's well-tolerated. It's hoped that this new method could offer a more convenient way to deliver glaucoma medication in the future.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Eyed Pharma

Enrolment target

Start

10 May 2024

Glaucoma

What is this study about?

Glaucoma is an eye condition where the nerve connecting your eye to your brain becomes damaged. This is often due to high pressure inside your eye. If not treated, it can lead to vision loss. Medicines called eye drops are a common way to lower this pressure, and a drug called timolol is often used.

This study is exploring a new way to deliver timolol. Instead of daily eye drops, researchers are testing a tiny implant that would be placed inside the eye and designed to release the medicine slowly over time. The idea is that this might make it easier and more consistent for people to get their medication.

This is a very early stage of research, sometimes called 'Phase 1'. It's the first time this specific implant is being tested in people. The main aim is to carefully check if the implant is safe and if people can tolerate having it in their eye without severe side effects. It's an important step to see if this new approach has potential for future glaucoma treatment.

Key takeaways

This study is testing a new eye implant for glaucoma.
It slowly releases timolol medicine to control eye pressure.
It's a very early safety study (Phase 1) in people.
For adults (18+) with primary open-angle glaucoma.
Could offer a new way to treat glaucoma in the future.

Who may be eligible?

To be considered for this study, you would need to be an adult, aged 18 years or older. There is no upper age limit, so older adults can also take part.

Both men and women are welcome to participate. The study is specifically for people who have been diagnosed with a type of glaucoma called primary open-angle glaucoma.

There will be other, more detailed health checks to make sure the study is a good fit for you and that taking part would be safe. These will be explained fully by the study team.

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 18 years old or older?
Have you been diagnosed with primary open-angle glaucoma?
Are you able to attend regular clinic appointments?
Are you generally healthy, apart from your glaucoma (the study team will check this)?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive the special implant which releases timolol. You would have regular check-ups at the study clinic to monitor your eye health and general well-being. These visits would involve eye examinations, pressure checks, and possibly blood tests to make sure everything is going well. The study team will explain exactly how many visits you would need, what each visit involves, and how long you would be followed up for after receiving the implant.

Potential risks and benefits

Taking part in any study has potential benefits and risks. A potential benefit of this study is receiving a new treatment that might make managing your glaucoma easier if it proves effective. You would also contribute valuable knowledge that could help others with glaucoma in the future. However, as this is a new implant, there's a risk of unknown side effects or that the implant might not work as intended. The common side effects of timolol eye drops are well known, but how the implant affects you might be different. The study team will carefully monitor you for any problems. Remember, you can stop participating in the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

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

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Unverified
Belgium
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Unverified
Germany

Common questions

What is glaucoma?

Glaucoma is an eye condition that can damage your vision, often due to high pressure inside your eye, affecting the nerve that connects your eye to your brain.

What is primary open-angle glaucoma?

This is the most common type of glaucoma where the drainage system in your eye doesn't work as well as it should, leading to increased eye pressure.

What does 'Human Pharmacology (Phase I)' mean?

It means this is a very early study, the first time this new implant is being tested in people. The main goal is to check how safe it is and if people can tolerate it.

What is timolol?

Timolol is a medicine commonly used in eye drops to lower the pressure inside the eye for people with glaucoma.

Will I get paid to take part?

Payment for participation varies between studies. The study team will be able to tell you if any expenses are covered or if you will receive payment.