Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Oxurion
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Written informed consent obtained from the subject prior to screening procedures
Male or female aged 18 years or older at the time of signing the informed consent
Type 1 or type 2 diabetes
BCVA ETDRS letter score ≤ 73 and ≥ 39 in the study eye (for subjects in Part A); BCVA ETDRS letter score ≤ 73 and ≥ 24 in the study eye (for subjects in Part B)
Central involved DME (CI-DME) with CST of ≥ 320µm in men or ≥ 305µm in women, on spectral domain optical coherence tomography (SD-OCT), in the study eye
Received ≥ 5 anti-vascular endothelial growth factor (anti-VEGF) injections for the treatment of CI-DME
BCVA ETDRS letter score ≥ 34 in the fellow eye
You may not be if
Macular edema due to causes other than DME in the study eye
Concurrent disease in the study eye, other than central-involved DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
Any condition that could confound the ability to detect the efficacy of the investigational medicinal product
Previous confounding medications / interventions, or their planned administration
Presence of neovascularisation at the disc in the study eye
Presence of iris neovascularisation in the study eye
Uncontrolled glaucoma in the study eye
Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
Untreated Diabetes Mellitus
Glycated haemoglobin A (HbA1c) \> 12%
Uncontrolled hypertension
Clareo Health | A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema
