Safety and Proof of Concept Study of ANXV (Annexin A5) in Patients With Diabetic Retinopathy or Retinal Vein Occlusion
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorAnnexin Pharmaceuticals AB
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
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
Trial design
Treatments tested in this trial
- ANXV
Treatment groups
12 Participants
are divided into 4 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov