A Study to Evaluate the Safety of THR-149 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:8/9/2018
Start Date:May 18, 2018
End Date:March 2019
Contact:Global Clinical Development
Email:info@thrombogenics.com
Phone:+32 (0)16 751 310

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A Phase 1, Open-label, Multicenter, Dose Escalation Study to Evaluate the Safety of a Single Intravitreal Injection of THR-149 for the Treatment of Diabetic Macular Edema (DME)

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


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
We found this trial at
7
sites
Boston, Massachusetts 02114
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Boston, MA
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Abilene, TX
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Austin, Texas 78705
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Austin, TX
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Houston, Texas 77030
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Houston, TX
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Huntingdon Valley, Pennsylvania 19006
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Huntingdon Valley, PA
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Phoenix, Arizona 85014
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Phoenix, AZ
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Reno, Nevada 89502
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Reno, NV
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