AuthorisedHuman Pharmacology (Phase I)- First administration to humansInterventional

Intravitreal (IVT) Pozelimab for Geographic Atrophy (GA) in Adult Participants

This is a very early study investigating a new medicine called Pozelimab for an eye condition known as Geographic Atrophy (GA). GA is a progressive eye disease that can lead to blurry vision and blind spots as it damages a part of the eye called the retina. This study is the first time Pozelimab will be given to people. The main goal is to check if the medicine is safe and how it behaves in the body, rather than how well it treats the condition. By understanding these early details, researchers can decide if the medicine should be studied further in larger trials.

At a glance

Status

Authorised

Phase

Human Pharmacology (Phase I)- First administration to humans

Sponsor

Regeneron Pharmaceuticals Inc.

Enrolment target

Start

23 Mar 2026

Geographic Atrophy

What is this study about?

This study is about an eye condition called Geographic Atrophy (GA). GA is a serious eye problem that slowly damages a part of your eye called the retina, which is responsible for your vision. Over time, this damage can cause significant vision loss and blind spots, making it harder to see details, read, or recognise faces. Currently, there are limited treatment options that can stop or reverse this damage, making new research very important.

Researchers are investigating a new medicine called Pozelimab. This particular study is the very first time this medicine will be given to people. It's a bit like taking the first steps with a new idea – the main goal at this stage isn't to see if it cures the condition, but to ensure it's safe and to understand how it works inside the human body.

By taking these early steps, scientists hope to gather important information. If Pozelimab appears to be safe and manageable, it could potentially move on to larger studies in the future. These later studies would then look more closely at whether the medicine can help slow down or stop the progression of Geographic Atrophy and protect people's vision.

Key takeaways

This is an early-stage study for a new eye medicine called Pozelimab.
It's the first time this medicine is being tested in people.
The main goal is to check for safety and how the medicine behaves in the body.
It's for adults with an eye condition called Geographic Atrophy (GA).
Participation helps future research, but doesn't guarantee personal vision improvement.

Who may be eligible?

To join this study, you must be an adult aged 18 or older. There is no upper age limit, meaning older adults are also welcome to participate.

Doctors will carefully check if this study is right for you. They will need to confirm that you have Geographic Atrophy. They will also look at your general health to make sure you can safely take part in the study and that the new medicine won't interfere with any other health conditions or treatments you might have. Not everyone with Geographic Atrophy will be able to join, as there are specific health requirements to ensure participant safety.

Both men and women are able to take part in this research. The study aims to be inclusive and learn from a diverse group of participants.

Quick self-check

Are you 18 years old or older?
Have you been diagnosed with Geographic Atrophy?
Are you generally healthy enough to participate in a study?
Are you able to attend regular clinic appointments?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

Information about what taking part in this specific study involves (like number of visits, specific tests, or how the medicine is given) isn't detailed here. However, in studies like this, participants typically have regular visits to the clinic for medical check-ups and tests. These tests might include detailed eye exams, blood tests, and scans to monitor your eye health and general well-being.

Participants would receive the study medicine, Pozelimab, likely given as an injection directly into the eye (an intravitreal injection). There would be a specific schedule for these injections and follow-up appointments to ensure safety and track progress. The total duration of participation isn't specified, but early-stage studies often have a follow-up period to monitor effects after the main treatment phase.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of joining this study is contributing to important medical research that could one day help people with Geographic Atrophy. You would also receive close medical attention and monitoring. However, as this is a first-in-human study, the main aim is safety, and there's no guarantee the medicine will improve your vision or condition. Potential risks could include side effects from the new medicine, such as discomfort or infection from eye injections, or other unknown effects. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

—
Romania

Common questions

What is Geographic Atrophy (GA)?

Geographic Atrophy (GA) is a progressive eye disease that causes damage to the retina, leading to blurry vision and blind spots over time.

What is Pozelimab?

Pozelimab is a new medicine being studied for the first time in people, to see if it's safe for treating Geographic Atrophy.

What does 'first administration to humans' mean?

It means this is the very first time this medicine is being given to people, so researchers are mainly focused on its safety and how it works in the body.

Will my vision improve if I join this study?

In this early stage of research, the main goal is to check safety, not to improve vision. There's no guarantee the medicine will help your eyes.

Who can take part in this study?

Adults aged 18 and over who have been diagnosed with Geographic Atrophy are generally considered, but doctors will check full eligibility.