RecruitingPHASE2INTERVENTIONAL

Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion

This research is looking into a new treatment called ANXV for two eye conditions: non-proliferative diabetic retinopathy and retinal vein occlusion. These conditions can cause vision problems. The main goals are to check if ANXV is safe for patients and to see if it can improve vision or reduce the need for other medications people might take. Researchers will try different doses of ANXV to work out which amount is best for future, larger studies. Participants will receive ANXV through a drip for 5 days and attend 11 clinic visits over 4 months for check-ups and tests. This study is an important step in understanding if ANXV could be a helpful treatment option.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Annexin Pharmaceuticals AB

Enrolment target

Start

07 Nov 2025

Estimated completion

01 Jul 2026

Non-Proliferative Diabetic Retinopathy Retinal Vein Occlusion

What is this study about?

This study is exploring a new potential treatment called ANXV for two specific eye conditions: non-proliferative diabetic retinopathy and retinal vein occlusion. These conditions can damage the small blood vessels in the retina, which is the light-sensitive layer at the back of your eye. This damage can lead to blurry vision or even more severe vision problems if not managed. The researchers are hoping to find out if ANXV could help to protect these blood vessels and improve eyesight.

The main purpose of this early-stage study (Phase 2) is to carefully assess the safety of ANXV in people with these conditions. It's crucial to understand any potential side effects. Alongside safety, the team also wants to see if ANXV actually makes a difference to vision or other signs of the disease in the eye. They'll be looking for improvements and also whether people need fewer 'rescue treatments' – additional medications sometimes given when symptoms worsen.

Another important aspect of this study is to compare different amounts (doses) of ANXV. By testing a few different doses, the researchers can determine which dose might be most effective and safest to use in larger studies in the future. This is a common step in developing new medicines, ensuring that they are thoroughly tested before potentially becoming widely available.

Key takeaways

This study is testing a new eye treatment, ANXV, for safety and effectiveness.
It targets non-proliferative diabetic retinopathy and retinal vein occlusion.
Participants will receive ANXV via a drip for 5 days and have 11 clinic visits over 4 months.
The study aims to see if ANXV improves vision and reduces the need for other treatments.
Researchers are comparing different doses of ANXV.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you must be 18 years or older and able to understand and sign the consent forms. Women of childbearing age cannot participate. Your eye must be clear enough for good quality pictures to be taken of the back of your eye, and you should be able to temporarily avoid very strenuous exercise.

If you have non-proliferative diabetic retinopathy, your condition needs to be classed as moderately severe or severe, and your vision in the study eye should be at least 6/12 (or 20/40). If you have retinal vein occlusion, the symptoms of your condition must have started within the last 28 days before you would start treatment.

You would not be able to join if you can't attend all the study visits, or if you've had major surgery or trauma recently or have one planned during the study. The study team will review your full medical history to make sure taking part would be safe for you.

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 or older?
Are you able to attend 11 clinic visits over 4 months?
Do you have moderately severe or severe non-proliferative diabetic retinopathy AND good enough vision, OR have you had retinal vein occlusion symptoms start in the last 28 days?
Are you able to temporarily avoid very strenuous exercise?
Have you not had any major surgery or serious trauma in the last 4 weeks, and don't have any planned during the study?

Answer every question to see your result.

What does participation involve?

If you decide to participate, you would receive the study medication, ANXV, through a slow drip (infusion) into your vein. This infusion would last for about 30 minutes and you would have it daily for 5 consecutive days. Over a period of 4 months, you would attend 11 clinic visits in total. These visits include an initial screening to check if you're suitable, the 5 treatment visits when you receive ANXV, and 5 follow-up visits.

During these visits, the research team will carry out various tests. These include eye assessments like checking your vision, taking scans and pictures of the back of your eye, and examining your eye with a special microscope. They will also perform general health checks such as measuring your blood pressure, taking an ECG (heart trace), and collecting blood and urine samples for safety and study-related tests. The total duration of your participation in the study would be approximately 4 months.

Potential risks and benefits

Taking part in any clinical trial involves potential benefits and risks. For this study, potential benefits might include closer monitoring of your eye condition and potentially receiving a new treatment that could improve your vision or reduce the need for other medications, though this is not guaranteed as it's an investigational treatment. Potential risks could include side effects from the ANXV medication or discomfort from the procedures, such as injections or eye drops for dilated pupils. All known risks will be fully explained to you before you agree to participate. You have the right to withdraw from 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.

The Retina Clinic London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What are non-proliferative diabetic retinopathy and retinal vein occlusion?

These are eye conditions that affect the blood vessels at the back of your eye, which can lead to vision problems.

What is ANXV?

ANXV is an experimental medicine being tested to see if it can help treat these eye conditions.

How will I receive ANXV?

You will receive ANXV through a slow drip into a vein daily for 5 days.

How long will the study last for me?

Your participation in the study will last for about 4 months, including clinic visits and follow-ups.

Can I stop participating if I want to?

Yes, you can choose to leave the study at any time without it affecting your medical care.

How to find out more

Anna Frostegård

anna.frostegard@annexinpharma.com +46701104258 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.