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

NCT07259928 | Recruiting Phase 2

• 2 other identifiers: ANN-0081012020
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Annexin A5; ANXV; Retinal Vein Occlusion; Non-Profilerative Diabetic Retinopathy; RVO; NPDR

Outcome Measures

Primary Outcomes (1)

• Safety and tolerability

  * Incidence and severity of Treatment Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) * Incidence and titre of anti-drug antibodies (ADA) to ANXV pre- and post-administration

  From day 1 to day 120

Secondary Outcomes (4)

• Anti-drug antibody

  From day 1 to day 120

• Proof of concept

  From day 1 to day 120

• ANXV concentration

  From start of administration up to four hours after start of administration, during all treatment days

• Rescue medication use

  From day 1 to day 120

Other Outcomes (3)

• ANXV binding sites

  From day 1 to day 120

• Cytokine profile

  From day 1 to day 120

• ANXV concentration in urine

  Four hours after start of treatment, for the third dose

Study Arms (4)

NPDR, 4mg, 5 doses

EXPERIMENTAL

ANXV 4mg 30 min infusion

Biological: ANXV

RVO, 4mg, 5 doses

EXPERIMENTAL

ANXV 4mg 30 min infusion

Biological: ANXV

NPDR, 6 mg, 5 doses

EXPERIMENTAL

ANXV 6mg 30 min infusion

Biological: ANXV

RVO, 4 mg, 3 doses

EXPERIMENTAL

ANXV 4mg 30 min infusion

Biological: ANXV

Interventions

ANXV BIOLOGICAL

Human Recombinant Protein Annexin A5

NPDR, 4mg, 5 doses; NPDR, 6 mg, 5 doses; RVO, 4 mg, 3 doses; RVO, 4mg, 5 doses

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• To be eligible to participate in this trial, an individual must meet all the following criteria:
• Must have given written informed consent (signed and dated), and any authorizations required by local law and be able to comply with all study requirements
• Male or female, ≥18 years of age at the time of informed consent
• Females should have no childbearing potential according to Clinical Trial Facilitation Group (CTFG) definition.
• Clear ocular media and adequate pupillary dilation in the Study Eye to permit high quality retinal imaging
• Willing to refrain from unusually strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) for at least 72 hours prior to study visits
• Additionally, NPDR participants must meet the following criteria to be eligible:
• Diagnosed with moderately severe or severe non-proliferative Diabetic Retinopathy defined as having a DRSS score of 47 and 53 respectively, and no CI-DMO
• Found to have an ETDRS BCVA score in the study eye (SE) of ≥69 ETDRS (equivalent to Snellen 6/12 or 20/40)
• Additionally, RVO participants must meet the following criteria to be eligible:
• Diagnosed with Retinal Vein Occlusion with onset of symptoms within 28 days prior to first administration of ANXV

You may not qualify if:

• An individual who meets any of the following criteria will be excluded from participation in this trial:
• General:
• Unwillingness or inability to attend all study visits and/or perform all procedures/tests/examinations, including follow-up, as specified by this protocol, or unwillingness to cooperate fully with the Investigator
• Any major medical or surgical procedure or trauma within 4 weeks prior to the day of trial intervention Treatment 1 (ANXV administration), or planned major surgery within the duration of the study through Day 120
• History of any clinically significant disease or disorder which, in the opinion of the Investigator, may either put the participant at risk because of participation in the study, or influence the results or the participant's ability to participate in the study
• Prior exposure to a recombinant Annexin A5 protein
• History of severe allergy/hypersensitivity or ongoing allergy/hypersensitivity, as judged by the Investigator, or history of hypersensitivity to biologics (for example systemically administered recombinant proteins/peptides; a similar drug class to ANXV)
• Uncontrolled hypertension (systolic \> 180 mmHg or diastolic \> 110 mmHg)
• Current use of any systemically administered anti-angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib) or corticosteroids
• Diagnosed untreated systemic metastasis malignancy
• A current systemic infection or inflammation that may require antiviral or antimicrobial therapy that will not be completed prior to Screening Visit, or that in the opinion of the Investigator and with concurrence of the Medical Monitor may either put the participant at risk or may influence the results of the study, or the participant's ability to participate in the study
• Treatment with another investigational drug, biological agent, or device within 3 months of Screening Visit, or 5 half-lives of investigational agent, whichever is longer or planned participation in an interventional trial from signing Informed Consent Form (ICF) through Day 120
• History of thromboembolic events or deep venous thrombosis within 3 months of Screening Visit
• Current use of anticoagulant medication (any medications that might have effect on coagulation, haemostasis, and platelets); low dose aspirin allowed prior to informed consent but must be stopped at the time of consent; may begin again 1 day post Treatment 5 infusion
• Current daily use of benzodiazepines

Sponsors & Collaborators

• Annexin Pharmaceuticals AB: lead

Study Sites (1)

The Retina Clinic London

London, W1G9AX, United Kingdom

RECRUITING

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal Diseases; Eye Diseases; Venous Thrombosis; Thrombosis; Embolism and Thrombosis; Vascular Diseases; Cardiovascular Diseases

Study Officials

• Anna Frostegård, MD, PhD

  Annexin Pharmaceuticals AB

  STUDY DIRECTOR

Central Study Contacts

Anna Frostegård

CONTACT

+46701104258; anna.frostegard@annexinpharma.com

Susan Suchdev

CONTACT

+46702079788; susan.suchdev@annexinpharma.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 16, 2025
• First Posted: December 2, 2025
• Study Start: November 7, 2025
• Primary Completion (Estimated): July 1, 2026
• Study Completion (Estimated): July 1, 2026
• Last Updated: December 2, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: During the study (as it is an open label study) and during a period after the study that is not yet defined

Locations

GB (1)