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A study to evaluate the safety and effectiveness of ANXV in patients with diabetic retinopathy or retinal vein occlusion

Verified siteInvestigationalNo placebo

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on two eye conditions: Diabetic Retinopathy, which is damage to the retina caused by diabetes, and Retinal Vein Occlusion, a condition where a blood vessel in the eye becomes blocked. The purpose of the study is to evaluate the safety and tolerability of a treatment called ANXV, which is a recombinant human Annexin A5 protein. This medication will be given through an intravenous infusion, meaning it is delivered directly into a vein.

During the study, participants will receive the medication and will be monitored for any side effects or how their bodies react to the treatment. The process involves checking for anti-drug antibodies, which are substances the body might create to fight against a medication. Researchers will also look at various aspects of eye health and how the medication moves through the body.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Administration of the test medication
The first step involves receiving an intravenous infusion, which is a method where medicine is delivered directly into a vein, of the study medication named ANXV.
The dose for the ANXV infusion is 6 mg (milligrams).
Step 2
Follow-up treatments and monitoring
Subsequent treatments are administered, with specific focus on the fourth and fifth treatment days to monitor how the medication behaves in the body.
During the first, fourth, and fifth treatment days, blood samples are taken at specific times: before the infusion, and at 15, 30, and 40 minutes, as well as at 1, 1.5, 2, and 4 hours after the infusion begins, to study the pharmacokinetics, which is how the body processes the medicine.
Step 3
Clinical evaluations
Various eye examinations are conducted to monitor the effects on the retina, which is the light-sensitive layer at the back of the eye.
These include OCT, a type of imaging used to see the different layers of the retina, and OCTA, which looks at the blood flow in the retina.
vision tests are performed to measure visual acuity, which is the sharpness of vision, and contrast sensitivity, which is the ability to see details in different lighting.
An electroretinogram (ERG) is used to measure the electrical response of the light-sensitive cells in the eye.
Specialized retinal imaging and angiography, which involves using a dye to examine blood vessels, are performed to check for vessel leakage or changes in the retina.
Step 4
Safety monitoring
The safety and tolerability of the medication are monitored by tracking any adverse events, which are any unwanted or harmful medical occurrences.
Blood tests are also conducted to check for anti-drug antibodies, which are proteins the immune system might create in response to the medication.

Who can join the trial?

10 criteria

You must be able to provide written informed consent, which means signing a document that explains the study and agreeing to participate.
You must be a male or female who is 18 years of age or older.
Women who are able to have children must not be in a group that has no childbearing potential, which means they are unable to become pregnant.
The clear parts of your eye, such as the lens and the fluid inside, must be clear ocular media so that doctors can see through them easily.
Your pupil, which is the black circle in the center of your eye, must be able to open wide enough (dilate) to allow for high-quality pictures of the back of your eye.
You must agree to avoid strenuous exercise, such as heavy lifting or intense workouts, for at least 72 hours before your study appointments.
If you have Diabetic Retinopathy (damage to the retina caused by diabetes), you must meet specific stages of the disease as determined by a scoring system called the DRSS.
For those with Diabetic Retinopathy, you must not have CI-DMO, which is a type of swelling in the center of the retina that needs immediate treatment.
If you have Diabetic Retinopathy, your vision acuity (how clearly you see) in the study eye must be at least a certain level, equivalent to seeing 20/50 on a standard eye chart.
If you have Retinal Vein Occlusion (a blockage in the blood vessels of the retina), your symptoms must have started within the last 28 days before receiving the study treatment.

Who cannot join the trial?

33 criteria

You are unwilling or unable to attend all scheduled study visits, complete all required tests, or follow the instructions provided by the study doctor.
You have used another experimental drug, biological medicine, or medical device within the last 3 months, or you plan to participate in another clinical trial during the study period.
You have a history of thromboembolic events, which are blood clots that travel through the blood vessels, or deep venous thrombosis, which is a blood clot typically located in the deep veins of the legs, within the last 3 months.
You are currently taking anticoagulant medications, which are medicines that thin the blood to prevent clots, or you have abnormal coagulation results, which refers to how well your blood clots.
You currently take benzodiazepines, which are a class of drugs used to treat anxiety or sleep problems, on a daily basis.
You have a history of autoimmune disease, a condition where the body's immune system mistakenly attacks its own healthy cells, such as lupus or rheumatoid arthritis.
You have an inherited blood disorder, which is a medical condition passed down through families, such as sickle cell disease or thalassemia.
You have a history of unstable heart disease or a cerebrovascular accident, which is the medical term for a stroke, within the last 3 months.
You have known kidney disease or your eGFR, which is a measure of how well your kidneys filter waste from your blood, is below 60.
You have a current problem with drug or alcohol abuse, or you smoke a large amount of nicotine, such as 20 or more cigarettes per day.
You have had or plan to have a major medical or surgical procedure, which is a complex or invasive surgery that requires a long recovery time, within 4 weeks of the study or during the study period.
You have a known chronic infection that affects the immune system, such as hepatitis B, hepatitis C, or HIV.
You have Class III obesity, which is defined by a Body Mass Index (a measure of body fat based on height and weight) of 40 or higher.
You have used medications in the last 6 months that are known to be harmful to the retina (the light-sensitive layer at the back of the eye), the lens, or the optic nerve (the nerve that carries visual information to the brain).
You have a known allergy to fluorescein (a dye used during eye exams) or any of the ingredients in the study products, or you have a condition that prevents your pupils from being dilated.
You have a severe Relative Afferent Pupillary Defect (RAPD), which is an abnormality in how the pupil reacts to light, in one or both eyes.
Your IOP, which stands for intraocular pressure (the fluid pressure inside your eye), is higher than 24 and is not controlled by medicine or surgery.
You have had uveitis, which is inflammation inside the eye, or an eye infection in the last 6 months.
You have evidence of neovascularization, which is the growth of new, abnormal blood vessels, in the eye being studied.
Your vision in the non-study eye is below a certain level, specifically an ETDRS BCVA score of 54 or less, which is a standardized way to measure visual acuity.
You have other eye diseases that could make it difficult to understand the study results or could put your safety at risk, such as glaucoma, retinal detachment, or a macular hole.
You have received certain eye injections, such as anti-VEGF treatments (medicines used to stop the growth of abnormal blood vessels) or corticosteroids (steroid medicines used to reduce inflammation), within specific timeframes before the study.
The eye being studied shows deep bleeding in the macula, which is the central part of the retina responsible for detailed vision.
The eye being studied has had certain types of laser surgery that could affect how the study medicine is assessed.
You have had eye surgery, such as cataract surgery, in the last 3 months or have eye surgery planned during the study.
You have had or currently have eye infections caused by certain viruses, such as herpes.
You have CI-DMO, which is a specific type of swelling in the central part of the retina, that requires immediate treatment.
You have previously used a recombinant Annexin A5 protein, which is a laboratory-made version of a specific protein.
You have a history of severe allergies to biologics, which are medicines made from living organisms.
You have uncontrolled hypertension, which is high blood pressure that stays above a certain level.
You are currently using medications that stop the growth of blood vessels or use steroids throughout your body.
You have a diagnosis of metastasis malignancy, which means cancer that has spread from its original location to other parts of the body, that has not been treated.
You have a current infection or inflammation that requires medicine that cannot be finished before the study begins.

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Universitaetsklinikum Tuebingen AöR
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Tuebingen, Germany

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Investigated drugs

ANXV is a protein made in a laboratory that is designed to target and attach to specific areas in the eye to help treat conditions like diabetic retinopathy or retinal vein occlusion.

ANXV

What is already known about the treatment

ANXV - This medication is administered as a liquid through an intravenous infusion directly into a vein. Currently being studied in clinical trials, this recombinant human protein aims to treat eye conditions like diabetic retinopathy and retinal vein occlusion. It works at a molecular level by binding to phosphatidylserine, a specific molecule found on the surface of damaged cells, to help prevent unwanted blood clotting and tissue damage. It is classified as a recombinant protein therapy designed to protect blood vessels in the eye.

Investigated diseases

Diabetic Retinopathy
This condition occurs when high blood sugar levels damage the blood vessels in the retina. Over time, these vessels may leak fluid or blood, causing swelling in the central part of the retina. In some cases, new, fragile blood vessels grow abnormally across the eye surface. These new vessels can leak or cause scarring, which may alter the structure of the retina. The disease typically progresses from mild damage to more advanced stages of vascular changes.
Retinal Vein Occlusion
This condition happens when the blood flow in a vein that carries blood from the retina to the eye is blocked. This blockage can be caused by a blood clot or narrowing of the vein. When the vein is obstructed, blood backs up, leading to swelling and leakage in the retina. This process can cause fluid to build up in the layers of the retina. As the condition progresses, it may lead to changes in the retinal blood vessels and increased pressure within the eye tissues.