A Study to Evaluate the Safety of THR-687 in Subjects With Diabetic Macular Edema (DME)
NCT ID: NCT03666923
Last Updated: 2020-01-22
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1
12 participants
INTERVENTIONAL
2018-09-17
2019-11-20
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SEQUENTIAL
TREATMENT
NONE
Study Groups
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THR-687 dose level 1
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 1
THR-687 dose level 1
single intravitreal injection of THR-687 dose level 1
THR-687 dose level 2
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 2
THR-687 dose level 2
single intravitreal injection of THR-687 dose level 2
THR-687 dose level 3
Subjects in this arm will receive a single intravitreal injection of THR-687 dose level 3
THR-687 dose level 3
single intravitreal injection of THR-687 dose level 3
Interventions
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THR-687 dose level 1
single intravitreal injection of THR-687 dose level 1
THR-687 dose level 2
single intravitreal injection of THR-687 dose level 2
THR-687 dose level 3
single intravitreal injection of THR-687 dose level 3
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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ThromboGenics
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Department
Role: STUDY_DIRECTOR
ThromboGenics Inc. A subsidiary of Oxurion NV.
Locations
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Retina Consultants of Arizona
Phoenix, Arizona, United States
Center for Retina and Macular Disease
Winter Haven, Florida, United States
Midwest Eye Institute
Indianapolis, Indiana, United States
Sierra Eye Associates
Reno, Nevada, United States
Palmetto Retinal Center
West Columbia, South Carolina, United States
Retina Research Institute of Texas
Abilene, Texas, United States
Valley Retina Institute, PA
McAllen, Texas, United States
Countries
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Other Identifiers
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THR-687-001
Identifier Type: -
Identifier Source: org_study_id
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