A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.

A Phase 2, Randomised, Multicentre Study to Assess the Dose Level of Multiple THR-687 Injections and to Evaluate the Efficacy and Safety of THR-687 Versus Aflibercept for the Treatment of Diabetic Macular Oedema (DME)

This study is conducted to select the THR-687 dose level (Part A of the study) and to assess the efficacy and safety of the selected dose level compared to aflibercept (Part B of the study).

In Part A, approximately 12 subjects are planned to be randomized (1:1 allocation) to THR-687 1.2mg and THR-687 2.0mg.

In Part B, in the cohort of Treatment Naïve subjects are planned to be randomized (2:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg.

In Part B, in the cohort of Previously Treated subjects are planned to be randomized (1:1 allocation) to THR-687 selected dose level from Part A and Aflibercept 2.0mg.

All subjects in the study will receive study treatment in one selected study eye only.

The subjects in this study will be subjects with central-involved DME (CI-DME). Both treatment-naïve and previously treated subjects will be included.

Inclusion Criteria:

• 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 ≥ 39 in the study eye
• CI-DME with CST of ≥ 300µm in men (or equivalent in women), measured from RPE to ILM inclusively, on SD-OCT, in the study eye
• BCVA ETDRS letter score ≥ 34 in the fellow eye

Exclusion Criteria:

• Macular edema due to causes other than DME in the study eye
• Concurrent disease in the study eye, other than DME, that could require medical or surgical intervention during the study period or could confound interpretation of the results
• Any condition in the study eye that could confound the ability to detect the efficacy of the investigational medicinal product
• Previous confounding medications / interventions, or their planned administration during the study
• Presence of iris neovascularisation in the study eye
• Uncontrolled glaucoma in the study eye
• Previously received THR-687 or any other experimental therapy for DME, in either eye
• Any active or suspected ocular or periocular infection, or active intraocular inflammation, in either eye
• Untreated Diabetes
• Glycated haemoglobin A (HbA1c) > 12%
• Uncontrolled hypertension