Trials Sponsors Conditions Drugs Pricing

Conditions

Diabetic Retinopathy Retinal Vein Occlusion Non-Proliferative Diabetic Retinopathy

Keywords

Annexin A5ANXVRetinal Vein OcclusionNon-Profilerative Diabetic RetinopathyRVONPDR

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

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

Interventions

ANXVBiological

Human Recombinant Protein Annexin A5

NPDR, 4mg, 5 dosesNPDR, 6 mg, 5 dosesRVO, 4 mg, 3 dosesRVO, 4mg, 5 doses

ANXVType not reported

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (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

Sponsors & Collaborators

Annexin Pharmaceuticals AB (publ)
Industrylead
Annexin Pharmaceuticals AB
Industrylead

Study Sites (1)

The Retina Clinic London

London, W1G9AX, United Kingdom

RECRUITING

Paulo Eduardo StangaCONTACT+44 20 4548 5310 p.stanga@theretinacliniclondon.com

Sebastian StangaCONTACT+44 20 4548 5310 sebastian@theretinacliniclondon.com

Paulo Eduardo StangaPRINCIPAL INVESTIGATOR

MeSH Terms

Conditions

Retinal Vein Occlusion

Condition Hierarchy (Ancestors)

Retinal DiseasesEye DiseasesVenous ThrombosisThrombosisEmbolism and ThrombosisVascular DiseasesCardiovascular 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

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

Actual (reported)

Primary Completion

July 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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
+24 more criteria

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

NPDR, 4mg, 5 doses

RVO, 4mg, 5 doses

NPDR, 6 mg, 5 doses

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (3)

RVO, 4 mg, 3 doses

You may not qualify if:

Data Sharing

Source records

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (4)

Study Arms (4)

NPDR, 4mg, 5 doses

RVO, 4mg, 5 doses

NPDR, 6 mg, 5 doses

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

Other Outcomes (3)

RVO, 4 mg, 3 doses

You may not qualify if:

Data Sharing

Source records

Locations