Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT02061865
Recruitment Status : Completed
First Posted : February 13, 2014
Last Update Posted : February 11, 2015
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals

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).

Condition or disease Intervention/treatment Phase
Neovascular Wet Age-related Macular Degeneration (AMD) Drug: REGN2176-3 Phase 1

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 12 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Study Start Date : February 2014
Actual Primary Completion Date : December 2014
Actual Study Completion Date : December 2014

Resource links provided by the National Library of Medicine


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



Primary Outcome Measures :
  1. 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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   50 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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:

  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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02061865


Locations
Layout table for location information
United States, California
Beverly Hills, California, United States
United States, Colorado
Colorado Springs, Colorado, United States
United States, Massachusetts
Boston, Massachusetts, United States
United States, Texas
Houston, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Layout table for investigator information
Study Director: Clinical Trial Management Regeneron Pharmaceuticals

Layout table for additonal information
Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT02061865     History of Changes
Other Study ID Numbers: R2176-3-AMD-1303
First Posted: February 13, 2014    Key Record Dates
Last Update Posted: February 11, 2015
Last Verified: February 2015

Additional relevant MeSH terms:
Layout table for MeSH terms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases