Status and phase
Conditions
Treatments
About
Open-label, dose ascending safety, tolerability, and proof of concept study to evaluate the use of ANXV (human recombinant Annexin A5) in the treatment of subjects with recently diagnosed Retinal Vein Occlusion.
Enrollment
Sex
Ages
Volunteers
Inclusion 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 must be non-pregnant and non-lactating, and either surgically sterile (e.g., ≥6 weeks post bilateral salpingectomy, bilateral oophorectomy with or without hysterectomy) or post-menopausal (12 months of spontaneous amenorrhea in females > 55years of age or, in females ≤55 years, or 12 months of spontaneous amenorrhea without an alternative medical, or 12 months with an elevated Follicle Stimulating Hormone (FSH) level Males must either be surgically sterile or abstinent*, or if engaged in sexual relations with a female of child-bearing potential, the subject or the subject's non-pregnant female partner must use a highly effective contraception method from the time of signing the Informed Consent Form (ICF) until at least 30 days after the last dose of study drug; Refer to Section 10.3 for acceptable methods
*Abstinence is only acceptable as true abstinence, i.e., when this is in line with the preferred and usual lifestyle of the subject; periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods). Declaration of abstinence for the duration of a trial and withdrawal are not acceptable methods of contraception (Section 10.3).
Onset of symptoms of Retinal Vein Occlusion within 14 days prior to informed consent
BCVA score of less than 69 letters and greater than 34 letters (approx. 20/40 - 20/200 Snellen equivalent) on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart in the Study Eye
Clear ocular media and adequate pupillary dilation in the Study Eye to permit high quality retinal imaging 9. Willing to refrain from strenuous exercise/activity (for example heavy lifting, weight training, intense aerobics classes etc.) for at least 72 hours prior to study visits 10. A negative rapid SARS-CoV-2 (COVID) test on Day 1 prior to initiation of study drug infusion
Exclusion criteria
Subjects will not be eligible if they have any of the following criteria:
Study Eye only:
Both Eyes:
Primary purpose
Allocation
Interventional model
Masking
16 participants in 5 patient groups
Loading...
Central trial contact
Anna Frostegård, MD, PhD; Susan Suchdev
Data sourced from clinicaltrials.gov
Clinical trials
Research sites
Resources
Legal