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
About this trial
This is an interventional basic science trial for Neovascular Age-Related Macular Degeneration
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).
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
NCT ID
NCT01997164
First Posted
November 22, 2013
Last Updated
January 11, 2016
Sponsor
Regeneron Pharmaceuticals
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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