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

Completed · Phase 1

Conditions studied: Neovascular Wet Age-related Macular Degeneration (AMD)

In brief

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).

Key facts

Study ID

NCT02061865

Run by

Regeneron Pharmaceuticals

People needed

12

Starts

2014-02-01

Expected to finish

2014-12-01

Last updated by the study team

2015-02-11

Who can join

Age: 50 and older. Sex: any. Healthy volunteers: not accepted.

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
• 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.

Where it is running

• Study site — Beverly Hills, California, United States
• Study site — Colorado Springs, Colorado, United States
• Study site — Boston, Massachusetts, United States
• Study site — Houston, Texas, United States

Full record on ClinicalTrials.gov

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