AuthorisedTherapeutic exploratory (Phase II)Interventional

Open-label, safety, tolerability and proof of concept study to evaluate the use of ANXV (recombinant human Annexin A5 protein) in the treatment of patients with either Diabetic Retinopathy or recent onset Retinal Vein Occlusion

This study is a research trial looking at a new medicine called ANXV. It's designed for people who have either diabetic retinopathy (an eye condition caused by diabetes) or retinal vein occlusion (a recent blood clot in the eye). The main goals are to check if ANXV is safe to use and how well people tolerate it. Researchers also want to see if it shows any signs of helping treat these eye conditions. This is an early stage (Phase II) study, meaning they are carefully exploring how the medicine behaves in the body and its potential effects, rather than confirming its effectiveness for widespread use.

At a glance

Status

Authorised

Phase

Therapeutic exploratory (Phase II)

Sponsor

Annexin Pharmaceuticals AB (publ)

Enrolment target

Start

02 Apr 2026

Diabetic Retinopathy, Retinal Vein Occlusion

What is this study about?

This research study is focused on exploring a new medication called ANXV. It's designed for people who have specific eye conditions: diabetic retinopathy or retinal vein occlusion. Diabetic retinopathy happens when high blood sugar levels damage the blood vessels in the light-sensitive tissue at the back of the eye, called the retina. This can lead to blurry vision or even blindness. Retinal vein occlusion is when a blood vessel carrying blood away from the retina gets blocked, which can also cause vision problems. Researchers hope ANXV might offer a new way to help people with these conditions.

The main purpose of this study is to find out if ANXV is safe for people to take and how well their bodies handle it. They will be looking very closely for any side effects or problems that might come up during the treatment. They also want to see if the body makes any antibodies against ANXV, which could affect how the medicine works. This is an 'open-label' study, meaning both the patients and the doctors will know they are receiving the ANXV treatment.

This is an early phase (Phase II) study, often called a 'therapeutic exploratory' study. This means the research team is trying to get a better understanding of the new medicine. They are not yet trying to prove that it definitely cures or treats the conditions, but rather to gather enough information to decide if it's promising enough to be studied in larger trials later on. They will be checking many aspects of eye health, including vision tests and detailed scans of the eye, to see if ANXV has any positive effects.

Key takeaways

This study is testing a new medicine (ANXV) for specific eye conditions.
It's for people with diabetic retinopathy or retinal vein occlusion.
The main goals are to check the medicine's safety and how well it's tolerated.
It's an early-stage study (Phase II) to gather more information.
Participants will know they are receiving the ANXV treatment.
Regular eye exams, scans, and blood tests will be part of the study.

Who may be eligible?

To be considered for this study, you need to be an adult, at least 18 years old. There's no upper age limit at this time, so older adults can also be included.

Both men and women are welcome to take part in this research. The study is specifically looking for people who have been diagnosed with either diabetic retinopathy or who have recently experienced a retinal vein occlusion. The researchers will have specific criteria about the severity or type of these conditions that you would need to meet.

Before joining, doctors will carefully check your medical history and perform examinations to make sure the study is right for you and that taking part would be safe. They will also make sure your eye condition fits the exact requirements for the study.

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 a diagnosis of diabetic retinopathy?
OR, have you recently been diagnosed with a retinal vein occlusion?
Are you willing and able to attend regular clinic visits and tests for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would receive the new medicine called ANXV. This medicine is given through a drip (intravenous infusion). You would have several visits to the study clinic for these treatments and for various checks and tests. These tests would include regular eye exams, detailed scans of your eyes (like OCT and OCTA), vision tests (such as reading letters from a chart and checking contrast sensitivity), and possibly other specific eye tests like electroretinograms (ERG) which measure electrical signals in your eye.

Blood samples will be taken at different times to check for any side effects, to see how your body is handling the medicine, and to understand how the medicine moves through your system. Researchers will also look for antibodies your body might make against the drug. You'll have follow-up visits to monitor your eye health and general well-being. The total length of your participation would be discussed in detail by the study team, typically involving several months of treatment and observation.

Potential risks and benefits

Taking part in this study might offer a potential benefit of receiving a new experimental treatment for your eye condition that isn't available outside of research. However, because ANXV is a new medicine, there are also potential risks involved, including side effects that are not yet fully known. The research team will carefully monitor you for any such effects. It's important to remember that you are free to withdraw from the study at any time, for any reason, without 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
Germany

Common questions

What is ANXV?

ANXV is a new, experimental medicine being tested in this study. It's a type of protein that scientists believe might help with certain eye conditions.

What eye conditions is this study looking at?

This study is for people who have either diabetic retinopathy (an eye problem linked to diabetes) or a recent retinal vein occlusion (a blood clot in the eye).

Will I know if I'm getting the real medicine?

Yes, this is an 'open-label' study, which means both you and the study doctors will know you are receiving the ANXV medicine.

What is a 'Phase II' study?

A Phase II study is an early stage of clinical research. It mainly focuses on checking if a new medicine is safe and if it shows any early signs of working, before it's tested in larger groups.

How long will I be in the study?

The exact duration will depend on the study plan, but it typically involves several months of treatment, follow-up visits, and monitoring. The study team will give you all the details.