Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)

January 11, 2016 updated by: Regeneron Pharmaceuticals

An Open-Label, Dose-Escalation Study of the Safety and Tolerability of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular AMD or DME

The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Beverly Hills, California, United States
    • Florida
      • Winter Haven, Florida, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • South Carolina
      • West Columbia, South Carolina, United States
    • Texas
      • Abilene, Texas, United States

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. For patients with AMD:

    1. Active subfoveal choroidal neovascularization (CNV) secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA or OCT in the study eye, as determined by the investigator
    2. Men or women ≥50 years and older

  2. For patients with DME:

    1. Patients with clinically significant DME with central involvement (≥300 μm in the central subfield on spectral domain OCT)
    2. Men or women ≥18 years and older

Key Exclusion Criteria:

  1. For patients with neovascular AMD:

    1. Evidence of choroidal neovascularization (CNV) due to any cause other than AMD in either eye
    2. Evidence of diabetic retinopathy (DR) or DME in either eye
  2. For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either eye
  3. Prior IAI in either eye
  4. IVT bevacizumab, ranibizumab, or pegaptanib sodium in the study eye within 8 weeks of day 1 or an AE with any of these previous treatments that would preclude administration of drug in this study
  5. Any prior treatment with angiopoietin inhibitors
  6. Any prior systemic (IV) anti-VEGF administration
  7. History of vitreoretinal surgery in the study eye
  8. Pan retinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of the screening visit
  9. Previous use of intraocular or periocular corticosteroids in the study eye within 4 months of screening

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: BASIC_SCIENCE
  • Allocation: NON_RANDOMIZED
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Cohorts 1 through 4
Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI
Drug: Intravitreal Aflibercept Injection (IAI)
Other Names:
  • EYLEA®
Drug: REGN910-3
EXPERIMENTAL: Cohort 5
Participants in cohort 5 will receive IVT REGN910 and IAI
Drug: Intravitreal Aflibercept Injection (IAI)
Other Names:
  • EYLEA®
Drug: REGN910

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of treatment-emergent adverse events (TEAEs)
Time Frame: Change from baseline to week 24
Incidence of TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910 TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910
Change from baseline to week 24

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pharmacokinetic (PK) profile
Time Frame: Baseline to week 24

PK profile may include, but is not limited to, the following:

  • AUCall - area under the curve (AUC) computed from time zero to the time of the last concentration
  • AUCall/Dose - AUCall-to-dose ratio
  • AUClast - AUC computed from time zero to the time of the last positive concentration
  • AUClast/Dose - AUClast-to-dose ratio
  • Cmax - the peak concentration
  • Cmax/Dose - Cmax-to-dose ratio
Baseline to week 24
Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3
Time Frame: Baseline to week 24
Baseline to week 24

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2014

Primary Completion (ACTUAL)

October 1, 2015

Study Completion (ACTUAL)

October 1, 2015

Study Registration Dates

First Submitted

November 22, 2013

First Submitted That Met QC Criteria

November 22, 2013

First Posted (ESTIMATE)

November 27, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

January 12, 2016

Last Update Submitted That Met QC Criteria

January 11, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R910-3-OD-1403

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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