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

Phase 1

Completed

• Conditions: Neovascular Wet Age-related Macular Degeneration (AMD)
• Interventions: Drug: REGN2176-3

• Registration Number: NCT02061865
• Lead Sponsor: 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).

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-28
• Study Start: 2014-02
• Study First Submitted QC: 2014-02-11
• Study First Posted: 2014-02-13
• Primary Completion: 2014-12
• Study Completion: 2014-12
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-09
• Last Update Posted: 2015-02-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 12

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Cohorts 1 - 4	REGN2176-3	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.

Primary Outcome Measures

Name	Time	Method
Safety	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.