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)

THR-687-002

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).

2021-08-27

2022-06-29

2022-06-29

Terminated

Early phase I

16

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

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2023-08-18