Clincosm LogoSign in Get a demo

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

Sponsor
River Vision Development Corporation (Industry)
Overall Status
Completed
CT.gov ID
NCT02103283
Collaborator
(none)
5
Enrollment
3
Locations
1
Arm
22
Duration (Months)
1.7
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
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).

Study Design

Study Type:
Interventional
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 :
Oct 1, 2014
Actual Primary Completion Date :
Aug 1, 2016
Actual Study Completion Date :
Aug 1, 2016

Arms and Interventions

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

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Safety of RV001in subjects with Diabetic Macular Edema [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 [Change from Baseline to Week 9]

      Pharmacodynamic measure includes change in Optical Coherence Tomography, Fluorescein Angiography and Stereoscopic color funds photos findings.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 David S Boyer Beverley Hills California United States 90211
    2 David A Eichenbaum, MD St. Petersburg Florida United States 33711
    3 Diana Do, MD Omaha Nebraska United States 68106

    Sponsors and Collaborators

    • River Vision Development Corporation

    Investigators

    • Principal Investigator: David S Boyer, MD, Retina Vitreous Associates Beverley Hills, California

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    River Vision Development Corporation
    ClinicalTrials.gov Identifier:
    NCT02103283
    Other Study ID Numbers:
    • DME01RV
    First Posted:
    Apr 3, 2014
    Last Update Posted:
    Aug 19, 2016
    Last Verified:
    Aug 1, 2016
    Keywords provided by River Vision Development Corporation
    Diabetic Macular Edema
    Additional relevant MeSH terms:
    Macular Edema
    Edema

    Study Results

    No Results Posted as of Aug 19, 2016