A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)
Status: | Recruiting |
---|---|
Conditions: | Cardiology, Ocular, Diabetes, Diabetes |
Therapuetic Areas: | Cardiology / Vascular Diseases, Endocrinology, Ophthalmology |
Healthy: | No |
Age Range: | 18 - Any |
Updated: | 12/6/2018 |
Start Date: | September 17, 2018 |
End Date: | June 2019 |
Contact: | Global Clinical Development |
Email: | info@thrombogenics.com |
Phone: | +32 (0)16 751 310 |
A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-687 for the Treatment of Diabetic Macular Edema (DME)
This study is conducted to evaluate the safety of a single intravitreal injection of THR-687.
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
We found this trial at
7
sites
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