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

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.

Study Overview

• Status: Completed
• Conditions: Diabetic Macular Edema
• Intervention / Treatment: Drug: Teprotumumab

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 Type: Interventional
• Enrollment (Actual): 5
• Phase: Phase 1

Contacts and Locations

Study Locations

• United States
  • California
    • Beverley Hills, California, United States, 90211
      • David S Boyer
  • Florida
    • St. Petersburg, Florida, United States, 33711
      • David A Eichenbaum, MD
  • Nebraska
    • Omaha, Nebraska, United States, 68106
      • Diana Do, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Teprotumumab; Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions	Drug: Teprotumumab; Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions; Other Names: RV 001

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: River Vision Development Corporation
• Investigators: Principal Investigator: David S Boyer, MD, Retina Vitreous Associates Beverley Hills, California

Study record dates

Study Major Dates

• Study Start: October 1, 2014
• Primary Completion (Actual): August 1, 2016
• Study Completion (Actual): August 1, 2016

Study Registration Dates

• First Submitted: March 27, 2014
• First Submitted That Met QC Criteria: March 31, 2014
• First Posted (Estimate): April 3, 2014

Study Record Updates

• Last Update Posted (Estimate): August 19, 2016
• Last Update Submitted That Met QC Criteria: August 17, 2016
• Last Verified: August 1, 2016

More Information

Terms related to this study

• Keywords: Diabetic Macular Edema
• Additional Relevant MeSH Terms: Eye Diseases; Retinal Degeneration; Retinal Diseases; Macular Degeneration; Macular Edema; Edema
• Other Study ID Numbers: DME01RV