A Study to Evaluate the Safety of THR-149 in Subjects With Diabetic Macular Edema (DME)

Inclusion Criteria:

- Male or female aged 18 years or older

- Type 1 or type 2 Diabetes Mellitus

- Central-involved DME with central subfield thickness of ≥ 320µm on Spectralis®
spectral domain optical coherence tomography (SD-OCT) or ≥ 305µm on non-Spectralis
SD-OCT, in the study eye

- Best-corrected visual acuity (BCVA) ≤ 62 and ≥ 23 ETDRS letter score in the study eye

- Written informed consent obtained from the subject prior to screening procedures

Exclusion Criteria:

- Macular edema due to causes other than DME

- Concurrent disease in the study eye, other than central-involved DME, that could
compromise BCVA, require medical or surgical intervention during the study period or
could confound interpretation of the results

- Any condition that could confound the ability to detect a change in central subfield
thickness in the study eye

- Previous confounding treatments / procedures, or their planned / expected use during
the study period

- Presence of neovascularization at the disc (NVD) in the study eye

- Uncontrolled glaucoma in the study eye

- Any active ocular / intra-ocular infection or inflammation in either eye

- Poorly controlled Diabetes Mellitus

- Uncontrolled hypertension