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

Diabetic Macular Edema Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02103283
• Other study ID #: DME01RV
• Status: Completed
• Phase: Phase 1
• First received: March 27, 2014
• Last updated: August 17, 2016
• Start date: October 2014
• Est. completion date: August 2016

Study information

• Verified date: August 2016
• Source: River Vision Development Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: August 2016
• Est. primary completion date: August 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Diabetic Macular Edema
• Edema
• Macular Edema

Intervention

Drug:
• Teprotumumab
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions

Locations

Country	Name	City	State
United States	David S Boyer	Beverley Hills	California
United States	Diana Do, MD	Omaha	Nebraska
United States	David A Eichenbaum, MD	St. Petersburg	Florida

Sponsors (1)

Lead Sponsor	Collaborator
River Vision Development Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	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	Yes