Actively Recruiting
Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion
Led by Annexin Pharmaceuticals AB · Updated on 2025-12-02
12
Participants Needed
1
Research Sites
33 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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
Official Title
Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Must have signed informed consent and be able to follow all study requirements
- Male or female, 18 years of age or older
- Females must have no childbearing potential as defined by Clinical Trial Facilitation Group (CTFG)
- Clear eye media and able to have high-quality retinal imaging in the study eye
- Willing to avoid unusually strenuous exercise for at least 72 hours before study visits
- NPDR participants must have moderately severe or severe non-proliferative diabetic retinopathy with a DRSS score of 47 or 53 and no clinically significant diabetic macular oedema
- NPDR participants must have an ETDRS BCVA score in the study eye of 69 or higher (equivalent to Snellen 6/12 or 20/40)
- RVO participants must have retinal vein occlusion diagnosed with symptom onset within 28 days before first ANXV treatment
You will not qualify if you...
- Unwilling or unable to attend all study visits or complete all procedures and follow-up
- Major surgery or trauma within 4 weeks before ANXV treatment, or planned major surgery during the study through day 120
- Significant medical condition or disorder that poses risk or affects study participation or results
- Prior exposure to recombinant Annexin A5 protein
- History or ongoing severe allergy or hypersensitivity to biologics or similar drugs
- Uncontrolled high blood pressure (systolic >180 mmHg or diastolic >110 mmHg)
- Current use of systemic anti-angiogenic agents or corticosteroids
- Untreated systemic metastatic cancer
- Current systemic infection or inflammation requiring antiviral or antimicrobial therapy not completed before screening
- Use of another investigational drug or device within 3 months before screening or planned participation in another trial during this study
- History of thromboembolic events or deep vein thrombosis within 3 months before screening
- Current use of anticoagulants except low-dose aspirin stopped at consent and restarted after treatment
- Daily use of benzodiazepines
- Abnormal coagulation tests at baseline
- History of autoimmune diseases with possible persistent Annexin A5 antibodies
- Inherited blood disorders like sickle cell disease or thalassemia
- Recent unstable heart disease or stroke within 3 months
- Known kidney disease or low kidney function (eGFR below 60)
- Current drug or alcohol abuse or heavy nicotine use
- Chronic infections affecting the immune system like hepatitis or HIV
- Class III obesity (BMI ≥40 kg/m2)
- Use of retina-toxic medications within 6 months prior to screening
- Known allergy to fluorescein or contraindication to pupil dilation
- Severe relative afferent pupillary defect or uncontrolled high intraocular pressure in study eye
- Recent or current eye infections, inflammation, or neovascularization
- Other eye diseases that may affect study results or require treatment during study
- Recent or ongoing anti-VEGF injections or eye surgeries in study eye
- Evidence of deep bleeding in the macula or recent laser treatment in study eye
- Recent ocular herpetic diseases
- NPDR participants with clinically significant diabetic macular oedema needing anti-VEGF or laser treatment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Retina Clinic London
London, United Kingdom, W1G9AX
Actively Recruiting
Research Team
A
Anna Frostegård
CONTACT
S
Susan Suchdev
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
4
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here