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

Primary Purpose

Diabetic Macular Edema

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Teprotumumab
Sponsored by
River Vision Development Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Macular Edema focused on measuring Diabetic Macular Edema

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • David S Boyer
  • David A Eichenbaum, MD
  • Diana Do, MD

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Teprotumumab

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

Safety of RV001in subjects with Diabetic Macular Edema
Pharmacodynamic measure includes change in Optical Coherence Tomography, Fluorescein Angiography and Stereoscopic color funds photos findings.

Full Information

First Posted
March 27, 2014
Last Updated
August 17, 2016
Sponsor
River Vision Development Corporation
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1. Study Identification

Unique Protocol Identification Number
NCT02103283
Brief Title
A Phase 1, Open-Label Study of Teprotumumab in Patients With Diabetic Macular Edema (DME)
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2016
Overall Recruitment Status
Completed
Study Start Date
October 2014 (undefined)
Primary Completion Date
August 2016 (Actual)
Study Completion Date
August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
River Vision Development Corporation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Macular Edema
Keywords
Diabetic Macular Edema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Teprotumumab
Arm Type
Experimental
Arm Description
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
Intervention Type
Drug
Intervention Name(s)
Teprotumumab
Other Intervention Name(s)
RV 001
Intervention Description
Teprotumumab 20mg/kg administered by intravenous infusion every 3 weeks for 3 infusions
Primary Outcome Measure Information:
Title
Safety of RV001in subjects with Diabetic Macular Edema
Description
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.
Time Frame
Change from Baseline to Week 9
Secondary Outcome Measure Information:
Title
Safety of RV001in subjects with Diabetic Macular Edema
Description
Pharmacodynamic measure includes change in Optical Coherence Tomography, Fluorescein Angiography and Stereoscopic color funds photos findings.
Time Frame
Change from Baseline to Week 9

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David S Boyer, MD
Organizational Affiliation
Retina Vitreous Associates Beverley Hills, California
Official's Role
Principal Investigator
Facility Information:
Facility Name
David S Boyer
City
Beverley Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
David A Eichenbaum, MD
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33711
Country
United States
Facility Name
Diana Do, MD
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68106
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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