A Study to Evaluate THR-149 Treatment for Diabetic Macular Oedema

Korábbi kezelés

• 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
• Previous confounding medications / interventions, or their planned administration

Más betegség

• Any condition that could confound the ability to detect the efficacy of the investigational medicinal product
• Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
• Untreated Diabetes Mellitus
• Uncontrolled hypertension

Laborértékek

• Glycated haemoglobin A (HbA1c) > 12%

Egyéb

• Macular edema due to causes other than DME in the study eye
• Presence of neovascularisation at the disc in the study eye
• Presence of iris neovascularisation in the study eye
• Uncontrolled glaucoma in the study eye

• 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