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Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD

Primary Purpose

Neovascular Wet Age-related Macular Degeneration (AMD)

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

REGN2176-3

About this trial

This is an interventional treatment trial for Neovascular Wet Age-related Macular Degeneration (AMD)

Eligibility Criteria

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

Inclusion Criteria:

Key Criteria:

Men or women greater than or equal to 50 years of age who provide informed consent and have active subfoveal choroidal neovascularization (CNV) secondary to wet AMD.

Exclusion Criteria:

Any prior treatment with an inhibitor of PDGF (platelet-derived growth factor) or PDGFR (platelet-derived growth factor receptor)
Active neovascular AMD in the fellow eye requiring treatment
Scar, fibrosis, or atrophy in the study eye involving the center of the fovea
Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
Prior vitrectomy in the study eye
Any history of macular hole of stage 2 and above in the study eye
Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
History of corneal transplant in the study eye
Positive serum human chorionic gonadotropin (hCG)/ urine pregnancy test at the screening or baseline visit

The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/ exclusion criteria are listed.

Sites / Locations

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Cohorts 1 - 4

Arm Description

Participants in cohort 1 will receive REGN2176-3 dosing regimen 1. Participants in cohort 2 will receive REGN2176-3 dosing regimen 2. Participants in cohort 3 will receive REGN2176-3 dosing regimen 3. Participants in cohort 4 will receive REGN2176-3 dosing regimen 4.

Outcomes

Primary Outcome Measures

Safety

The primary endpoint in the study is the incidence of treatment emergent adverse events (TEAEs) from day 1 through week 24 in patients treated with IVT REGN2176-3.

Secondary Outcome Measures

Full Information

NCT ID

NCT02061865

First Posted

January 28, 2014

Last Updated

February 9, 2015

Sponsor

Regeneron Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT02061865

Brief Title

Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD

Study Type

Interventional

2. Study Status

Record Verification Date

February 2015

Overall Recruitment Status

Completed

Study Start Date

February 2014 (undefined)

Primary Completion Date

December 2014 (Actual)

Study Completion Date

December 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Regeneron Pharmaceuticals

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The primary objective of the study is to investigate the safety of intravitreal (IVT) REGN2176-3 in patients with neovascular wet age-related macular degeneration (AMD).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neovascular Wet Age-related Macular Degeneration (AMD)

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

12 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Cohorts 1 - 4

Arm Type

Experimental

Arm Description

Intervention Type

Drug

Intervention Name(s)

REGN2176-3

Primary Outcome Measure Information:

Title

Safety

Description

The primary endpoint in the study is the incidence of treatment emergent adverse events (TEAEs) from day 1 through week 24 in patients treated with IVT REGN2176-3.

Time Frame

day 1 through week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Key Criteria: Men or women greater than or equal to 50 years of age who provide informed consent and have active subfoveal choroidal neovascularization (CNV) secondary to wet AMD. Exclusion Criteria: Any prior treatment with an inhibitor of PDGF (platelet-derived growth factor) or PDGFR (platelet-derived growth factor receptor) Active neovascular AMD in the fellow eye requiring treatment Scar, fibrosis, or atrophy in the study eye involving the center of the fovea Presence of retinal pigment epithelial tears or rips involving the macula in the study eye Prior vitrectomy in the study eye Any history of macular hole of stage 2 and above in the study eye Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery History of corneal transplant in the study eye Positive serum human chorionic gonadotropin (hCG)/ urine pregnancy test at the screening or baseline visit The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial and not all inclusion/ exclusion criteria are listed.

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

Colorado Springs

State/Province

Colorado

Country

United States

City

Boston

State/Province

Massachusetts

Country

United States

City

Houston

State/Province

Texas

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD

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