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

February 9, 2015 updated by: Regeneron Pharmaceuticals
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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

12

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
    • Colorado
      • Colorado Springs, Colorado, United States
    • Massachusetts
      • Boston, Massachusetts, United States
    • Texas
      • Houston, 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

50 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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:

  1. Any prior treatment with an inhibitor of PDGF (platelet-derived growth factor) or PDGFR (platelet-derived growth factor receptor)
  2. Active neovascular AMD in the fellow eye requiring treatment
  3. Scar, fibrosis, or atrophy in the study eye involving the center of the fovea
  4. Presence of retinal pigment epithelial tears or rips involving the macula in the study eye
  5. Prior vitrectomy in the study eye
  6. Any history of macular hole of stage 2 and above in the study eye
  7. Any intraocular or periocular surgery within 3 months of day 1 in the study eye, except lid surgery
  8. History of corneal transplant in the study eye
  9. 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.

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: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Cohorts 1 - 4
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.
Drug: REGN2176-3

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Safety
Time Frame: day 1 through week 24
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.
day 1 through 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

February 1, 2014

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

December 1, 2014

Study Registration Dates

First Submitted

January 28, 2014

First Submitted That Met QC Criteria

February 11, 2014

First Posted (Estimate)

February 13, 2014

Study Record Updates

Last Update Posted (Estimate)

February 11, 2015

Last Update Submitted That Met QC Criteria

February 9, 2015

Last Verified

February 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R2176-3-AMD-1303

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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