Phase 1 Safety Study With Intravitreal (IVT) REGN2176-3 in Patients Aged 50 Years and Older With Wet AMD
1 other identifier
interventional
12
1 country
4
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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Feb 2014
4 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 28, 2014
CompletedStudy Start
First participant enrolled
February 1, 2014
CompletedFirst Posted
Study publicly available on registry
February 13, 2014
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2014
CompletedFebruary 11, 2015
February 1, 2015
10 months
January 28, 2014
February 9, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
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.
day 1 through week 24
Study Arms (1)
Cohorts 1 - 4
EXPERIMENTALParticipants 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.
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (4)
Unknown Facility
Beverly Hills, California, United States
Unknown Facility
Colorado Springs, Colorado, United States
Unknown Facility
Boston, Massachusetts, United States
Unknown Facility
Houston, Texas, United States
Study Officials
- STUDY DIRECTOR
Clinical Trial Management
Regeneron Pharmaceuticals
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 28, 2014
First Posted
February 13, 2014
Study Start
February 1, 2014
Primary Completion
December 1, 2014
Study Completion
December 1, 2014
Last Updated
February 11, 2015
Record last verified: 2015-02