A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)
NCT ID: NCT02103283
Last Updated: 2025-06-25
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
5 participants
INTERVENTIONAL
2014-10-31
2016-08-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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Teprotumumab
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
Teprotumumab
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
Interventions
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Teprotumumab
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* IGF 1 in serum \> 106 ng/mL
* Women of child-bearing potential must have negative pregnancy test and be willing and able to use two different methods of contraception, one of which must be oral contraceptive or depot formulation. Males must be surgically sterile or agree to use barrier contraception
* Clinically significant DME of less than 12 months duration
* Non-proliferative diabetic retinopathy of moderate severity
* Best corrected electronic ETDRS letter score \< 78 and \> 24
Exclusion Criteria
* Significant renal disease, myocardial infarction, stroke, transient ischemic attack, acute congestive heart failure
* Blood pressure \> 180/110
* Anti-vascular endothelial growth factor (VEGF) treatment within two months prior to enrollment
* History of pan retinal photocoagulation within four months prior to enrollment
* History of ocular surgery within four months prior to enrollment
* History of systemic treatment with corticosteroids within 3 months prior to enrollment
18 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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David S Boyer
Beverly Hills, California, United States
David A Eichenbaum, MD
St. Petersburg, Florida, United States
Diana Do, MD
Omaha, Nebraska, United States
Countries
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Other Identifiers
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DME01RV
Identifier Type: -
Identifier Source: org_study_id
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