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ANXV

Clinical trials are investigating ANXV in people with diabetic retinopathy and retinal vein occlusion. These studies aim to evaluate safety, tolerability, and early signs of benefit in small patient groups. One trial listed here is a phase 2 study.

Table of contents

Trial overview

The listed clinical trial is NCT07259928, titled “Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion (NEXUS).”[1] It is an authorised phase 2 study with an enrollment goal of 18 participants.[1] The study is testing ANXV in people with eye disease to learn more about safety and early signs of benefit.[1]

Conditions studied

This trial is focused on two eye conditions: diabetic retinopathy and retinal vein occlusion.[1] Diabetic retinopathy is an eye disease linked to diabetes, and retinal vein occlusion is a blockage in a vein in the retina, the light-sensitive part of the eye.[1] Both conditions can affect vision, which is why they are important targets for research.[1]

Study design and phase

The study is an interventional trial, which means participants receive the study treatment so researchers can measure its effects.[1] ANXV is given as a 6 mg intravenous infusion, meaning it is delivered through a vein.[1] As a phase 2 study, it is designed to build on early research and look more closely at safety and possible benefit in a small group.[1]

Who can participate

The trial is for participants who have either diabetic retinopathy or retinal vein occlusion.[1] The available data do not list more detailed entry rules, so the main known target group is people with one of these two eye conditions.[1] The study plans to include 18 people, which makes it a small early-stage trial.[1]

What is measured in the trial

The main outcome measures are treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs).[1] These are used to track any medical problems that appear after treatment starts, especially problems that are severe or serious.[1] The trial also measures the incidence and titre of anti-drug antibodies (ADA) before and after ANXV is given.[1] This helps researchers see whether the body makes an immune response against the study treatment.[1]

Why this study matters

This study is an early step in learning whether ANXV can be studied further in eye disease.[1] Because it includes a small number of participants and focuses on safety, it is meant to provide early clinical information rather than final proof of effectiveness.[1] The results may help researchers decide whether larger studies should be done in diabetic retinopathy or retinal vein occlusion.[1]

Trial ID Phase Condition studied Status Enrollment
NCT07259928 Phase 2 Diabetic retinopathy; retinal vein occlusion Authorised 18

FAQ

  • What is being studied in ANXV clinical trials? The trial is studying ANXV in people with diabetic retinopathy or retinal vein occlusion. It is looking at safety, tolerability, and early proof of concept.
  • Who may take part in the ANXV trial? The listed study includes participants with diabetic retinopathy or retinal vein occlusion. The trial is designed for a small group of 18 people.
  • What phase is the ANXV trial? The listed study is a phase 2 trial. Phase 2 studies usually look at safety and early signs that a treatment may help.
  • What results are measured in the ANXV trial? The main results are treatment-emergent adverse events, serious adverse events, and anti-drug antibodies. These help researchers see if the study treatment is safe and whether the body reacts to it.
  • What conditions are being studied with ANXV? The trial focuses on diabetic retinopathy and retinal vein occlusion. Both are eye conditions that can affect vision.

Ongoing Clinical Trials on ANXV

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

    Not yet recruiting

    1 1
    Investigated diseases:
    Investigated drugs:
    Germany

Glossary

  • Diabetic retinopathy: An eye disease caused by diabetes. It can damage the blood vessels in the retina, which is the light-sensitive layer at the back of the eye.
  • Retinal vein occlusion: A blockage in a vein in the retina. This can reduce blood flow and may affect vision.
  • Retina: The thin layer at the back of the eye that senses light and sends visual signals to the brain.
  • Phase 2: A stage in clinical research where a treatment is studied in a small group of people to look at safety and early signs of benefit.
  • Interventional study: A study where participants receive a treatment or procedure so researchers can measure its effects.
  • Intravenous infusion: A treatment given through a vein, usually by a slow drip.
  • Treatment-emergent adverse events (TEAEs): Medical problems that start or get worse after a person begins the study treatment.
  • Serious adverse events (SAEs): Severe medical problems that may need hospital care, cause lasting harm, or be life-threatening.
  • Anti-drug antibodies (ADA): Proteins made by the immune system that may react against a study treatment.
  • Proof of concept: Early research that checks whether a treatment shows signs it may work in the target disease.

References