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)

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Regeneron Pharmaceuticals
Study ID
NCT01997164
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

Study Details

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).

Key Dates

Start date
Nov 30, 2014
Status verified
Jan 2016
Primary completion
Oct 31, 2015
Completion
Oct 31, 2015

Study Design

Enrollment
20 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
BASIC_SCIENCE

Arms

  • Experimental: Cohorts 1 through 4
    Participants in cohorts 1 through 4 will receive IVT REGN910-3 and IAI
  • Experimental: Cohort 5
    Participants in cohort 5 will receive IVT REGN910 and IAI

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) [ Time Frame: Change from baseline to week 24 ]

Locations (5)

FacilityCityStateZIPSite coordinators
-Beverly HillsCalifornia--
-Winter HavenFlorida--
-BostonMassachusetts--
-West ColumbiaSouth Carolina--
-AbileneTexas--

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