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

• Status: Completed
• Trial end date: 2019-05-22
• Target enrollment: 0
• Participant gender: All

Summary

This study is conducted to evaluate the safety of a single intravitreal injection of THR-149.

• Phase: Phase 1
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: ThromboGenics

Criteria

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