A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)



Status:Recruiting
Conditions:Cardiology, Ocular
Therapuetic Areas:Cardiology / Vascular Diseases, Ophthalmology
Healthy:No
Age Range:18 - Any
Updated:4/21/2016
Start Date:October 2014
End Date:October 2016
Contact:Kathie Gabriel, BSN, MFT
Email:kcgabriel2@verizon.net
Phone:610-937-1932

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Phase 1, Open-Label Safety and Pharmacodynamic Study of RV001, an Insulin-Like Growth Factor-1 Receptor (IGF-1R) Antagonist, Administered by Intravenous (IV) Infusion in Patients With Diabetic Macular Edema (DME)

A Phase 1 Study to evaluate the Safety of teprotumumab in Patients with Diabetic Macular
Edema.

A Phase 1, Open-Label Safety and Pharmacodynamic Study of RV 001, an Insulin-Like Growth
Factor-1 Receptor (IGF-1) Antagonist, Given By IV Infusion in Patients with Diabetic Macular
Edema (DME).

Inclusion Criteria:

- Diagnosis of diabetes mellitus with Hemoglobin A1c <8.5%

- 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:

- Unstable-uncontrolled diabetes as demonstrated by a change in diabetes medication
greater than 15% in the previous 60 days.

- 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
We found this trial at
3
sites
Beverley Hills, California 90211
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Beverley Hills, CA
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Omaha, Nebraska 68106
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Omaha, NE
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St. Petersburg, Florida 33711
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St. Petersburg, FL
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