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

Inclusion Criteria: To be eligible to participate in this trial, an individual must meet all the following criteria: 1. 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 2. Male or female, ≥18 years of age at the time of informed consent 3. Females should have no childbearing potential according to Clinical Trial Facilitation Group (CTFG) definition. 4. Clear ocular media and adequate pupillary dilation in the Study Eye to permit high quality retinal imaging 5. 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: 6. 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 7. 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: 8. Diagnosed with Retinal Vein Occlusion with onset of symptoms within 28 days prior to first administration of ANXV Exclusion Criteria: An individual who meets any of the following criteria will be excluded from participation in this trial: General: 1. 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 2. 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 3. 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 4. Prior exposure to a recombinant Annexin A5 protein 5. 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) 6. Uncontrolled hypertension (systolic \> 180 mmHg or diastolic \> 110 mmHg) 7. Current use of any systemically administered anti-angiogenic agent (e.g., bevacizumab, sunitinib, cetuximab, sorafenib, pazopanib) or corticosteroids 8. Diagnosed untreated systemic metastasis malignancy 9. 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 10. 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 11. History of thromboembolic events or deep venous thrombosis within 3 months of Screening Visit 12. 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 13. Current daily use of benzodiazepines 14. Clinically significant abnormal coagulation parameters at baseline 15. History of autoimmune disease with anticipated presence of persistent Annexin A5 antibodies, e.g., antiphospholipid syndrome, systemic lupus erythematosus, rheumatoid arthritis, Behcet disease or systemic sclerosis 16. Inherited blood disorder (e.g. sickle cell disease, thalassemia) 17. History of unstable coronary artery disease or cerebrovascular accident within the last 3 months 18. Current known kidney disease or evidence of kidney disease and eGFR below 60 mL/min/1.73m2 at baseline 19. Current drug or alcohol abuse as per the opinion of the Investigator, or current excessive nicotine intake (e.g. ≥ 20 cigarettes/day, or equivalent, as per the opinion of the Investigator) 20. Known history of or positive test for chronic infection that affect the immune system (e.g. hepatitis C (HCV), chronic hepatitis B (HBV) and HIV) 21. Class III obesity (Body Mass Index ≥ 40kg/m2), at the time of informed consent 22. Within 6 months prior to the Screening Visit, use of medications known to be toxic to the retina, lens, or optic nerve (e.g., deferoxamine, chloroquine/hydrochloroquine, chlorpromazine, phenothiazines, tamoxifen, and ethambutol) 23. Known hypersensitivity or allergy to fluorescein (e.g., bronchospasm, rash, etc.) or to any component of the study products or a contraindication to dilation of the pupil or fixed pupils; mild allergies without angio-oedema or treatment need may be acceptable if deemed not to be of clinical significance (including but not limited to allergy to animals or mild seasonal hay fever) Either or both eyes: 24. A severe (≥0.9 log, Grade 3+ or worse) Relative Afferent Pupillary Defect (RAPD) 25. An IOP greater than 24 mmHg that is not controlled with medication or surgery at the time of the Screening Visit 26. Recent (6 months) history of, or presence of uveitis, presence of intraocular inflammation (history of blepharitis is not exclusionary), current ocular infection 27. Evidence of neovascularization 28. ETDRS BCVA score in the Fellow eye of ≤54 (equivalent to Snellen 6/24 or 20/80) 29. Ocular disorders/additional eye disease, which in the opi