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

Phase 1

Completed

• Conditions: Diabetic Macular Edema
• Interventions: Drug: Teprotumumab

• Registration Number: NCT02103283
• Lead Sponsor: River Vision Development Corporation

Brief Summary

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

Detailed Description

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).

Study Timeline

• Study First Submitted: 2014-03-27
• Study First Submitted QC: 2014-03-31
• Study First Posted: 2014-04-03
• Study Start: 2014-10
• Status Verified: 2016-08
• Primary Completion: 2016-08
• Study Completion: 2016-08
• Last Update Submitted: 2016-08-17
• Last Update Posted: 2016-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Teprotumumab	Teprotumumab	Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions

Primary Outcome Measures

Name	Time	Method
Safety of RV001in subjects with Diabetic Macular Edema	Change from Baseline to Week 9	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.

Secondary Outcome Measures

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

Trial Locations

Locations (3)

David A Eichenbaum, MD; 🇺🇸 St. Petersburg, Florida, United States

Diana Do, MD; 🇺🇸 Omaha, Nebraska, United States

David S Boyer; 🇺🇸 Beverley Hills, California, United States