Phoenix, Arizona 85053


Purpose:

This study is conducted to evaluate the safety of a single intravitreal injection of THR-687.


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 expected to require confounding treatments / procedures at any time 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


NCT ID:

NCT03666923


Primary Contact:

Study Director
Clinical Department
ThromboGenics Inc. A subsidiary of Oxurion NV.

Global Clinical Development
Phone: +32 (0)16 751 310
Email: info@thrombogenics.com


Backup Contact:

N/A


Location Contact:

Phoenix, Arizona 85053
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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