Trial record 2 of 45 for:    regeneron | Open Studies

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)

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2015 by Regeneron Pharmaceuticals
Sponsor:
Information provided by (Responsible Party):
Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier:
NCT01997164
First received: November 22, 2013
Last updated: April 2, 2015
Last verified: April 2015
  Purpose

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).


Condition Intervention Phase
Neovascular Age-Related Macular Degeneration
Diabetic Macular Edema
Drug: REGN910-3
Drug: REGN910
Drug: Intravitreal Aflibercept Injection (IAI)
Phase 1

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official 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

Resource links provided by NLM:


Further study details as provided by Regeneron Pharmaceuticals:

Primary Outcome Measures:
  • Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Change from baseline to week 24 ] [ Designated as safety issue: Yes ]
    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 Outcome Measures:
  • Pharmacokinetic (PK) profile [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]

    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

  • Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3 [ Time Frame: Baseline to week 24 ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: November 2014
Estimated Study Completion Date: October 2015
Estimated Primary Completion Date: October 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cohorts 1 through 4
Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI
Drug: REGN910-3 Drug: Intravitreal Aflibercept Injection (IAI)
Other Name: EYLEA®
Experimental: Cohort 5
Participants in cohort 5 will receive IVT REGN910 and IAI
Drug: REGN910 Drug: Intravitreal Aflibercept Injection (IAI)
Other Name: EYLEA®

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Key Inclusion Criteria:

  1. For patients with AMD:

    1. 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
    2. Men or women ≥50 years and older
  2. For patients with DME:

    1. Patients with clinically significant DME with central involvement (≥300 μm in the central subfield on spectral domain OCT)
    2. Men or women ≥18 years and older

Key Exclusion Criteria:

  1. For patients with neovascular AMD:

    1. Evidence of choroidal neovascularization (CNV) due to any cause other than AMD in either eye
    2. Evidence of diabetic retinopathy (DR) or DME in either eye
  2. For patients with DME: Evidence of neovascular AMD or CNV due to any cause in either eye
  3. Prior IAI in either eye
  4. 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
  5. Any prior treatment with angiopoietin inhibitors
  6. Any prior systemic (IV) anti-VEGF administration
  7. History of vitreoretinal surgery in the study eye
  8. Pan retinal laser photocoagulation or macular laser photocoagulation in the study eye within 3 months of the screening visit
  9. 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).

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01997164

Contacts
Contact: Clinical Trials Administrator clinicaltrials@regeneron.com

Locations
United States, California
Recruiting
Beverly Hills, California, United States
United States, Florida
Recruiting
Winter Haven, Florida, United States
United States, Massachusetts
Recruiting
Boston, Massachusetts, United States
United States, South Carolina
Recruiting
West Columbia, South Carolina, United States
United States, Texas
Recruiting
Abilene, Texas, United States
Sponsors and Collaborators
Regeneron Pharmaceuticals
Investigators
Study Director: Clinical Trial Management Regeneron Pharmaceuticals
  More Information

No publications provided

Responsible Party: Regeneron Pharmaceuticals
ClinicalTrials.gov Identifier: NCT01997164     History of Changes
Other Study ID Numbers: R910-3-OD-1403
Study First Received: November 22, 2013
Last Updated: April 2, 2015
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Macular Degeneration
Macular Edema
Wet Macular Degeneration
Eye Diseases
Retinal Degeneration
Retinal Diseases

ClinicalTrials.gov processed this record on April 26, 2015