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

NCT02103283 | Completed Phase 1

• 1 other identifier: DME01RV
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 3

Brief Summary

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

Conditions

Diabetic Macular Edema

Keywords

Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Safety of RV001in subjects with Diabetic Macular Edema

  Change from Baseline to Week 9

Study Arms (1)

Teprotumumab

EXPERIMENTAL

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

Drug: Teprotumumab

Interventions

Teprotumumab DRUG

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

Also known as: RV 001

Teprotumumab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Amgen: lead

Study Sites (3)

David S Boyer

Beverly Hills, California, 90211, United States

Location

David A Eichenbaum, MD

St. Petersburg, Florida, 33711, United States

Location

Diana Do, MD

Omaha, Nebraska, 68106, United States

Location

MeSH Terms

Interventions

teprotumumab

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2014
• First Posted: April 3, 2014
• Study Start: October 1, 2014
• Primary Completion: August 1, 2016
• Study Completion: August 1, 2016
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

US (3)