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)

NCT01997164 | Completed Phase 1

• 1 other identifier: R910-3-OD-1403
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 5

Brief Summary

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).

Conditions

Neovascular Age-Related Macular Degeneration; Diabetic Macular Edema

Outcome Measures

Primary Outcomes (1)

• Incidence of treatment-emergent adverse events (TEAEs)

  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

  Change from baseline to week 24

Secondary Outcomes (2)

• Pharmacokinetic (PK) profile

  Baseline to week 24

• Development of Anti-drug antibodies (ADA) after IVT injection of REGN910-3

  Baseline to week 24

Study Arms (2)

Cohorts 1 through 4

EXPERIMENTAL

Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI

Drug: REGN910-3; Drug: Intravitreal Aflibercept Injection (IAI)

Cohort 5

EXPERIMENTAL

Participants in cohort 5 will receive IVT REGN910 and IAI

Drug: REGN910; Drug: Intravitreal Aflibercept Injection (IAI)

Interventions

REGN910-3 DRUG

Cohorts 1 through 4

REGN910 DRUG

Cohort 5

Intravitreal Aflibercept Injection (IAI) DRUG

Also known as: EYLEA®

Cohort 5; Cohorts 1 through 4

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Regeneron Pharmaceuticals: lead

Study Sites (5)

Unknown Facility

Beverly Hills, California, United States

Location

Unknown Facility

Winter Haven, Florida, United States

Location

Unknown Facility

Boston, Massachusetts, United States

Location

Unknown Facility

West Columbia, South Carolina, United States

Location

Unknown Facility

Abilene, Texas, United States

Location

MeSH Terms

Interventions

aflibercept

Study Officials

• Clinical Trial Management

  Regeneron Pharmaceuticals

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 22, 2013
• First Posted: November 27, 2013
• Study Start: November 1, 2014
• Primary Completion: October 1, 2015
• Study Completion: October 1, 2015
• Last Updated: January 12, 2016

Record last verified: 2016-01

Locations

US (5)