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 Diabetic Retinopathy or Recent Onset Retinal Vein Occlusion
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.
⁃ 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