A Study to Evaluate THR-687 Treatment for Diabetic Macular Oedema.
Condition: Diabetes Mellitus; Diabetic Retinopathy; Diabetic Macular Edema
MeSH terms: Macular Edema; Diabetic Retinopathy; Edema
Intervention: THR-687 dose level 1; THR-687 dose level 2; THR-687 selected dose level; Aflibercept
Intervention description: 3 intravitreal injections of THR-687 dose level 1, 1 month apart; 3 intravitreal injections of THR-687 dose level 2, 1 month apart; 3 intravitreal injections of THR-687 selected dose level, 1 month apart, possibly followed by a 4th intravitreal injection with the same dose level of THR-687 at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.; 3 intravitreal injections of aflibercept, 1 month apart, possibly followed by a 4th intravitreal injection with aflibercept at Month 3, or Month 4, or Month 5, if any of the PRN criteria are met.
Intervention MeSH terms: Aflibercept
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 16.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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).
    

Eligibility 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