Skip to main content
OpenTrials
Completed

NCT Number: NCT01997164

Study of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular ("Wet") Age Related Macular Degeneration (AMD) or Diabetic Macular Edema (DME)

The primary objective of the study is to investigate the safety and tolerability of intravitreal (IVT) REGN910-3 and IVT REGN910 in patients with neovascular age-related macular degeneration (AMD), and separately in patients with diabetic macular edema (DME).

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Beverly Hills, California, United States

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Key Inclusion Criteria:

  • For patients with AMD:
  • Active subfoveal choroidal neovascularization (CNV) secondary to AMD, including juxtafoveal lesions that affect the fovea as evidenced by FA or OCT in the study eye, as determined by the investigator
  • Men or women ≥50 years and older
  • For patients with DME:
  • Patients with clinically significant DME with central involvement (≥300 μm in the central subfield on spectral domain OCT)
  • Men or women ≥18 years and older

Key Exclusion Criteria:

  • For patients with neovascular AMD:
  • Evidence of choroidal neovascularization (CNV) due to any cause other than AMD in either eye
  • Evidence of diabetic retinopathy (DR) or DME in either eye
  • For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either eye
  • Prior IAI in either eye
  • IVT bevacizumab, ranibizumab, or pegaptanib sodium in the study eye within 8 weeks of day 1 or an AE with any of these previous treatments that would preclude administration of drug in this study
  • Any prior treatment with angiopoietin inhibitors
  • Any prior systemic (IV) anti-VEGF administration
  • History of vitreoretinal surgery in the study eye
  • Pan retinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of the screening visit
  • Previous use of intraocular or periocular corticosteroids in the study eye within 4 months of screening

(The inclusion/ exclusion criteria provided above are not intended to contain all considerations relevant to a subject's potential participation in this clinical trial).

Treatment and study plan

REGN910-3

Drug

REGN910

Drug

Intravitreal Aflibercept Injection (IAI)

Drug

Other names: EYLEA®

Primary outcomes

  1. Incidence of treatment-emergent adverse events (TEAEs)

    Time frame: Change from baseline to week 24

    Incidence of TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910 TEAEs through week 24 in patients treated with IVT REGN910-3 and IVT REGN910

Secondary outcomes

  1. Pharmacokinetic (PK) profile

    Time frame: Baseline to week 24

    PK profile may include, but is not limited to, the following:

    • AUCall - area under the curve (AUC) computed from time zero to the time of the last concentration
    • AUCall/Dose - AUCall-to-dose ratio
    • AUClast - AUC computed from time zero to the time of the last positive concentration
    • AUClast/Dose - AUClast-to-dose ratio
    • Cmax - the peak concentration
    • Cmax/Dose - Cmax-to-dose ratio
  2. Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3

    Time frame: Baseline to week 24

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

An Open-Label, Dose-Escalation Study of the Safety and Tolerability of Intravitreal (IVT) REGN910-3 and IVT REGN910 in Patients With Either Neovascular AMD or DME

Important dates

Study start
2014
Primary completion
2015
Study completion
2015
First posted
Nov 27, 2013
Registry last updated
Jan 12, 2016

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.

Published trials that share one or more normalized conditions with this study.