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

• Status: Recruiting
• Trial end date: 2023-08-01
• Target enrollment: 0
• Participant gender: All

Summary

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).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Oxurion
• Treatments: Aflibercept

Criteria

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