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NCT02061865 Clinical Trial

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

Neovascular Wet Age-related Macular Degeneration (AMD) Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02061865
Other study ID # R2176-3-AMD-1303
Secondary ID
Status Completed
Phase Phase 1
First received January 28, 2014
Last updated February 9, 2015
Start date February 2014
Est. completion date December 2014

Study information
Verified date February 2015
Source Regeneron Pharmaceuticals
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial 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).

Recruitment information / eligibility
Status Completed
Enrollment 12
Est. completion date December 2014
Est. primary completion date December 2014
Accepts healthy volunteers No
Gender Both
Age group 50 Years and older
Eligibility 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

Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• REGN2176-3

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Regeneron Pharmaceuticals

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary 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 Yes