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

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).

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Key information

Conditions

Neovascular Wet Age-related Macular Degeneration (AMD)

Age range

50 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beverly Hills, California, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

REGN2176-3

Drug

Primary outcomes

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.

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2014
Study completion: 2014
First posted: Feb 13, 2014
Registry last updated: Feb 11, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.