SMR-4202

• Research type

  Research Study

• Full title

  Open-label, safety, tolerability and proof of concept study to evaluate the use of ANXV (recombinant human Annexin A5 protein) in the treatment of patients with either non-proliferative Diabetic Retinopathy or recent onset Retinal Vein Occlusion.

• IRAS ID

  1012020

• Contact name

  Amanda Knock

• Contact email

  amanda.knock@smerud.com

• Sponsor organisation

  Annexin Pharmaceuticals AB

• Clinicaltrials.gov Identifier

  NCT07259928

• Research summary

  This is a phase 2a clinical study conducted at one site (the Retina Clinic, London). Participants aged 18 or over with diabetic retinopathy or retinal vein occlusion will be treated with ANXV, which is an almost identical copy of the human protein Annexin A5. All humans produce Annexin A5 naturally to help in the protection and repair of damaged cells.
  The purpose of this study is to investigate the safety and tolerability, as well as signals of effect of ANXV in diabetic retinopathy and retinal vein occlusion, two eye diseases that can lead to irreversible vision loss and blindness. There is currently no cure for diabetic retinopathy although treatment can slow disease progression and there is no approved treatment for retinal vein occlusion before complications arise.
  Up to 18 male and female participants will be selected to take part in this study. Potential participants will be reviewed for eligibility into the study; their general health and vital signs will be reviewed and their eye disease assessed. Each participant will receive 3 or 5 infusions of ANXV directly into a vein in their arm or hand (takes 30 minutes) during a period of up to 8 days. After ANXV treatment they will receive eye assessments, blood and urine tests as well as a review of their general health. The participants will be asked to attend the clinic for 5 more follow-up visits (up to 120 days) for further eye assessments and blood tests.

• REC name

  East Midlands - Nottingham 2 Research Ethics Committee

• REC reference

  25/EM/0125

• Date of REC Opinion

  25 Jul 2025

• REC opinion

  Further Information Favourable Opinion