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
This trial does not accept healthy volunteersQualifiers
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
Design model
Sequential
Treatments tested in this trial
ANXV
Biological/VaccineHuman Recombinant Protein Annexin A5
Treatment groups
12 Participants
are divided into 4 treatment groupsGroup A: NPDR, 4mg, 5 dosesExperimental treatment 1 intervention
Group B: RVO, 4mg, 5 dosesExperimental treatment 1 intervention
Group C: NPDR, 6 mg, 5 dosesExperimental treatment 1 intervention
Group D: RVO, 4 mg, 3 dosesExperimental treatment 1 intervention
Trial outcomes
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
Time frame
From day 1 to day 120Secondary outcomes
1
Anti-drug antibody
Presence of anti-drug antibodies to ANXV
Time frame
From day 1 to day 1202
Proof of concept
Efficacy measured by eye functional and anatomical assessments.
Time frame
From day 1 to day 1203
ANXV concentration
ANXV concentration in blood and urine
Time frame
From start of administration up to four hours after start of administration, during all treatment days4
Rescue medication use
Number of rescue medication occasions
Time frame
From day 1 to day 120Other outcomes
1
ANXV binding sites
Amount of ANXV binding sites (phosphatidylserine) in plasma and on erythrocytes
Time frame
From day 1 to day 1202
Cytokine profile
Cytokine profile in plasma
Time frame
From day 1 to day 1203
ANXV concentration in urine
ANXV concentration in urine, to evaluate excretion
Time frame
Four hours after start of treatment, for the third doseSponsors and contacts
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Source ClinicalTrials.gov