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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)

Primary Purpose

Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
REGN910-3
REGN910
Intravitreal Aflibercept Injection (IAI)
Sponsored by
Regeneron Pharmaceuticals
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Neovascular Age-Related Macular Degeneration

Eligibility Criteria

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

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).

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cohorts 1 through 4

Cohort 5

Arm Description

Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI

Participants in cohort 5 will receive IVT REGN910 and IAI

Outcomes

Primary Outcome Measures

Incidence of treatment-emergent adverse events (TEAEs)
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

Secondary Outcome Measures

Pharmacokinetic (PK) profile
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
Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3

Full Information

First Posted
November 22, 2013
Last Updated
January 11, 2016
Sponsor
Regeneron Pharmaceuticals
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1. Study Identification

Unique Protocol Identification Number
NCT01997164
Brief Title
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)
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
January 2016
Overall Recruitment Status
Completed
Study Start Date
November 2014 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neovascular Age-Related Macular Degeneration, Diabetic Macular Edema

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
20 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohorts 1 through 4
Arm Type
Experimental
Arm Description
Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI
Arm Title
Cohort 5
Arm Type
Experimental
Arm Description
Participants in cohort 5 will receive IVT REGN910 and IAI
Intervention Type
Drug
Intervention Name(s)
REGN910-3
Intervention Type
Drug
Intervention Name(s)
REGN910
Intervention Type
Drug
Intervention Name(s)
Intravitreal Aflibercept Injection (IAI)
Other Intervention Name(s)
EYLEA®
Primary Outcome Measure Information:
Title
Incidence of treatment-emergent adverse events (TEAEs)
Description
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
Time Frame
Change from baseline to week 24
Secondary Outcome Measure Information:
Title
Pharmacokinetic (PK) profile
Description
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
Time Frame
Baseline to week 24
Title
Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3
Time Frame
Baseline to week 24

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: For patients with AMD: 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 Men or women ≥50 years and older For patients with DME: Patients with clinically significant DME with central involvement (≥300 μm in the central subfield on spectral domain OCT) Men or women ≥18 years and older Key Exclusion Criteria: For patients with neovascular AMD: Evidence of choroidal neovascularization (CNV) due to any cause other than AMD in either eye Evidence of diabetic retinopathy (DR) or DME in either eye For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either eye Prior IAI in either eye 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 Any prior treatment with angiopoietin inhibitors Any prior systemic (IV) anti-VEGF administration History of vitreoretinal surgery in the study eye Pan retinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of the screening visit 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).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Clinical Trial Management
Organizational Affiliation
Regeneron Pharmaceuticals
Official's Role
Study Director
Facility Information:
City
Beverly Hills
State/Province
California
Country
United States
City
Winter Haven
State/Province
Florida
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
West Columbia
State/Province
South Carolina
Country
United States
City
Abilene
State/Province
Texas
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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)

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