Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

An open-label, single group, single-dose clinical study to evaluate the usability of the pre-filled syringe (PFS) of SB11 in trial participants with Neovascular Age-Related Macular Degeneration (AMD), Macular Oedema Secondary to Retinal Vein Occlusion (RVO), or Myopic Choroidal Neovascularization (mCNV)

This clinical study is designed to test a new way of giving an eye medicine called Byooviz using a pre-filled syringe (PFS). The main goal is to see how easy it is for people with specific eye conditions to use this new syringe. These conditions include wet age-related macular degeneration (AMD), swelling in the back of the eye due to a blocked blood vessel (macular oedema from RVO), and short-sightedness causing new blood vessel growth (myopic choroidal neovascularization, mCNV). Researchers will check how successfully participants can complete certain tasks with the syringe on the first day. They will also monitor for any side effects and see if there are any changes in vision.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Samsung Bioepis Co. Ltd.

Enrolment target

Start

01 Jun 2025

Neovascular Age-Related Macular Degeneration (AMD)Macular Oedema Secondary to Retinal Vein Occlusion (RVO)Myopic Choroidal Neovascularization (mCNV)

What is this study about?

This study is looking at a new way to deliver an eye medicine called Byooviz. Instead of drawing the medicine from a vial, it comes in a special pre-filled syringe (PFS). The main reason for this study is to find out if this pre-filled syringe is easy and straightforward to use for patients and healthcare professionals.

You might be interested in this study if you have certain eye conditions that affect your vision. These include 'wet' age-related macular degeneration (AMD), which is a common cause of sight loss in older people. It also includes macular oedema, which is swelling at the back of the eye caused by a blocked blood vessel (retinal vein occlusion or RVO), and myopic choroidal neovascularization (mCNV), which is new, unwanted blood vessel growth that can happen with very short-sightedness.

The idea is to make sure that giving this important eye medicine is as simple and safe as possible. By testing the usability of the pre-filled syringe, the researchers hope to make the treatment process easier for people who need it to help protect their eyesight.

Key takeaways

Tests a new pre-filled syringe for eye medicine (Byooviz).
Aims to make eye injections simpler and safer.
For adults with certain eye conditions like wet AMD.
Participation involves one dose and about 7 days of follow-up.
Focuses on how easy the syringe is to use and safety.

Who may be eligible?

To join this study, you need to be an adult, 18 years old or older. There is no upper age limit, so people of all adult ages can take part.

This study is open to both men and women.

Crucially, you would need to have one of the specific eye conditions being studied, which are wet age-related macular degeneration (AMD), macular oedema from retinal vein occlusion (RVO), or myopic choroidal neovascularization (mCNV). The study team will check your medical history and conduct examinations to confirm you meet all the necessary health requirements.

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?
Do you have 'wet' Age-related Macular Degeneration (AMD)?
Or do you have macular swelling from a blocked eye vessel (RVO)?
Or do you have new blood vessel growth with severe short-sightedness (mCNV)?
Are you able to attend appointments for about 7 days?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you would receive a single dose of the Byooviz medicine using the pre-filled syringe. This study is mainly focused on how easy it is to use the syringe, so you would be asked to complete several tasks with it on day one.

Beyond that, the total duration of your participation would be quite short. You would have follow-up appointments and assessments mainly for safety checks for seven days after receiving the medicine. This means checking for any side effects and potentially measuring your vision again after this short period. The study team will explain everything in detail, including how many visits you would need to make.

Potential risks and benefits

Participating in research always carries potential benefits and risks. A potential benefit of this study is contributing to our understanding of a more convenient way to deliver eye medication, which could lead to easier treatment for many people in the future. You will also receive the study medication and close medical attention. Potential risks include possible side effects from the medication (which will be closely monitored) and discomfort from the injections or examinations. Remember, you can choose to leave 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
Poland

Common questions

What is a 'pre-filled syringe'?

It's a syringe that already contains the right amount of medicine, ready to be used, which can make injections simpler and safer.

What kind of eye conditions is this study for?

It's for specific conditions that affect the macula (the central part of your vision) like wet AMD, macular oedema due to RVO, and myopic choroidal neovascularization.

How long will I be in the study?

Your active participation, including follow-up for safety, will be for about seven days after you receive the medicine.

Will I get the actual medicine?

Yes, you will receive a single dose of Byooviz solution for injection as part of this study.

What does 'usability' mean in this study?

It means how easy and successful it is for people to use the pre-filled syringe, and if there are any difficulties.