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

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

Detailed Description
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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).

Official Title
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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)

Conditions
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Diabetic Macular Edema

Intervention / Treatment
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* Drug: Teprotumumab


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Teprotumumab<br>Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions | Drug: Teprotumumab<br>* Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions<br>* Other names: RV 001;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of RV001in subjects with Diabetic Macular Edema | Number of subjects with adverse events, serious adverse events and early discontinuations due to adverse events. Number of subjects with clinical significant abnormal laboratory values, electrocardiograms (pre and post infusions), abnormal vital signs, ophthalmic and physical examinations. | Change from Baseline to Week 9 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety of RV001in subjects with Diabetic Macular Edema | Pharmacodynamic measure includes change in Optical Coherence Tomography, Fluorescein Angiography and Stereoscopic color funds photos findings. | Change from Baseline to Week 9 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Diabetic Macular Edema