Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion
NCT07259928 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-12-02
Summary
The goal of this clinical trial is to learn about the safety of the investigational medicinal product ANXV. It will also learn about how ANXV works to treat non-proliferative diabetic retinopathy and retinal vein occlusion in adults. The main questions it aims to answer are:
* Is ANXV safe to use?
* Does ANXV improve vision or findings related to vision decrease caused by non-proliferative diabetic retinopathy or retinal vein occlusion?
* Does ANXV lower the number of times participants need to use a rescue medication? Researchers will compare different dose levels of ANXV to see what dose would be be appropriate to test in larger studies.
Participants will:
Take ANXV as a 30 minutes infusion (slow injection) for 5 days. Visit the clinic for checkups and tests at 11 visits during 4 months.
Conditions
- Non-Proliferative Diabetic Retinopathy
- Retinal Vein Occlusion
Interventions
- BIOLOGICAL
-
ANXV
Human Recombinant Protein Annexin A5
Sponsors & Collaborators
-
Annexin Pharmaceuticals AB
lead INDUSTRY
Principal Investigators
-
Anna Frostegård, MD, PhD · Annexin Pharmaceuticals AB
Study Design
- Allocation
- NON_RANDOMIZED
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-11-07
- Primary Completion
- 2026-07-31
- Completion
- 2026-07-31
Countries
- United Kingdom
Study Locations
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