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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02103283
Recruitment Status : Completed
First Posted : April 3, 2014
Last Update Posted : August 19, 2016
Sponsor:
Information provided by (Responsible Party):
River Vision Development Corporation

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

Condition or disease Intervention/treatment Phase
Diabetic Macular Edema Drug: Teprotumumab Phase 1

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).

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 5 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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 Start Date : October 2014
Actual Primary Completion Date : August 2016
Actual Study Completion Date : August 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Edema

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 Name: RV 001




Primary Outcome Measures :
  1. Safety of RV001in subjects with Diabetic Macular Edema [ Time Frame: 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 :
  1. Safety of RV001in subjects with Diabetic Macular Edema [ Time Frame: Change from Baseline to Week 9 ]
    Pharmacodynamic measure includes change in Optical Coherence Tomography, Fluorescein Angiography and Stereoscopic color funds photos findings.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02103283


Locations
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United States, California
David S Boyer
Beverley Hills, California, United States, 90211
United States, Florida
David A Eichenbaum, MD
St. Petersburg, Florida, United States, 33711
United States, Nebraska
Diana Do, MD
Omaha, Nebraska, United States, 68106
Sponsors and Collaborators
River Vision Development Corporation
Investigators
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Principal Investigator: David S Boyer, MD Retina Vitreous Associates Beverley Hills, California
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Responsible Party: River Vision Development Corporation
ClinicalTrials.gov Identifier: NCT02103283    
Other Study ID Numbers: DME01RV
First Posted: April 3, 2014    Key Record Dates
Last Update Posted: August 19, 2016
Last Verified: August 2016
Keywords provided by River Vision Development Corporation:
Diabetic Macular Edema
Additional relevant MeSH terms:
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Macular Edema
Edema
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases