Ongoing, recruitingTherapeutic confirmatory (Phase III)Interventional

A Phase 3, Randomized, Double-Blind, Parallel Group, Multicenter Study to Compare Efficacy, Safety, Pharmacokinetics, and Immunogenicity of BP05 Versus EU-Approved Lucentis® in Patients with Wet (Neovascular) Age-Related Macular Degeneration

This UK clinical trial is looking at a new version of a common eye medicine called ranibizumab, which is similar to Lucentis. It's for people with wet age-related macular degeneration, a condition that affects your central vision. The main goal is to compare how well this new version (called BP05) works against the existing Lucentis at improving vision, and to check if it's just as safe. Participants will receive injections into their eye, and doctors will carefully check their vision and overall health over a long period. This type of study is an important step to make sure any new medicine is effective and safe before it can be widely used.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Curateq Biologics Private Limited, Curateq Biologics Private Limited

Enrolment target

Start

21 May 2024

wet macula degeneration

What is this study about?

This study is about a common eye condition called wet age-related macular degeneration, often shortened to 'wet AMD'. This condition affects the part of your eye responsible for sharp, central vision, making everyday tasks like reading or recognising faces difficult. One of the main treatments for wet AMD involves injections of a medicine called ranibizumab, which helps to stop abnormal blood vessels from growing in the eye that cause vision problems. Lucentis is a well-known brand of ranibizumab.

In this particular study, scientists are testing a new version of ranibizumab, referred to as BP05, to see how it compares to the Lucentis treatment that is already approved and used in the UK. They want to find out if this new version works just as well at improving and maintaining vision. They'll also be closely monitoring its safety, looking for any side effects.

This kind of study is called a 'Phase 3' trial, which means it's one of the final steps in testing a new medicine. It involves a larger number of patients and aims to confirm the results from earlier, smaller studies. The goal is to make sure that if this new version of ranibizumab is approved, it will be a safe and effective option for people living with wet AMD.

Key takeaways

This study is testing a new version of an eye medicine for wet AMD.
It compares a new medicine (BP05) to existing Lucentis.
The main goals are to check vision improvement and safety.
Participants will receive eye injections and have regular eye checks.
It's a 'Phase 3' study, an important step before new medicines are available.

Who may be eligible?

To join this study, you generally need to be an adult, aged 18 years or older, with wet age-related macular degeneration. Both men and women are welcome to participate.

There will be other detailed medical checks to make sure the study is suitable and safe for you. For example, the doctors will need to confirm your diagnosis, and check your general health and any other medical conditions you might have. You would not be able to join if you are pregnant or breastfeeding, or if you have certain other eye conditions or health problems that could affect the study results or your safety.

It’s important to discuss your full medical history with the study team to see if you meet all the requirements. They will explain everything clearly during your first visit.

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 wet age-related macular degeneration?
Are you able to attend regular clinic appointments for about a year?
Are you comfortable receiving injections into your eye as part of your treatment?
Are you currently not pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive regular injections into your eye, either of the new medicine (BP05) or the existing Lucentis, though you wouldn't know which one you are getting. Doctors will regularly check your eyesight using a special chart, similar to the one you might see at an optician, to see if your vision is improving or stable. They will also take detailed scans of your eye, like OCT scans, to look at the fluid and blood vessels, and sometimes pictures using a dye (FA) to check for leakage.

You will have regular blood tests to check how the medicine is working in your body and to monitor for any immune reactions. Your overall health will be closely watched, including blood pressure and other vital signs. The study will also involve regular checks for any side effects, particularly those affecting your eyes or general health. You will have several clinic visits over a period of about a year, with possible follow-up visits after that. Each visit will involve various assessments, and the study team will let you know the exact schedule.

Potential risks and benefits

Taking part in a clinical trial has potential benefits, such as receiving close medical attention and access to a new treatment before it's widely available. There's a chance the new treatment might work better for you, or just as well as existing treatments. However, there are also potential risks, including side effects from the injections or the medicine itself. These could range from mild discomfort at the injection site to more serious, but rare, eye complications or general health issues. The research team will explain all known risks to you in detail. You are free to withdraw from the study at any time, for any reason, without it affecting your 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
Slovakia
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Unverified
Latvia

Common questions

What is 'wet age-related macular degeneration'?

Wet AMD is an eye condition where abnormal blood vessels grow in the back of your eye, leaking fluid and blood, which can blur or distort your central vision.

What is Lucentis (ranibizumab)?

Lucentis is a common medicine used to treat wet AMD. It's given as an injection into the eye and helps stop the abnormal blood vessels from growing and leaking.

Will I know if I'm getting the new medicine or Lucentis?

No, this is a 'double-blind' study, meaning neither you nor your doctor will know if you are receiving the new medicine (BP05) or the standard Lucentis. This helps ensure fair results.

How long will I need to be in the study?

Your participation will involve regular visits and assessments over approximately one year, with potential for longer follow-up depending on the study's design.

What does 'Phase 3' mean for a clinical trial?

Phase 3 means this is a large, advanced study aiming to confirm if a new treatment is effective and safe compared to existing options, before it can be approved for wider use.