A Safety and Efficacy Study of DE-120 Injectable Solution for Age-related Macular Degeneration

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Santen Inc.
Study ID
NCT02401945
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

Study Details

The purpose of the study is to evaluate the safety and efficacy of intravitreal (IVT) administration of DE-120 in subjects with treatment-naive active subfoveal choroidal neovascularization (CNV) secondary to age-related macular degeneration (AMD).

Key Dates

Start date
Apr 30, 2015
Status verified
Apr 2018
Primary completion
Jun 22, 2016
Completion
Oct 31, 2016

Study Design

Enrollment
16 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: DE-120 Monotherapy
    DE-120 intravitreal injection given as monotherapy on a PRN basis
  • Experimental: Eylea® and DE-120 Concomitant Therapy
    DE-120 intravitreal injection given on a PRN basis after Aflibercept (Eylea®) injection as an induction therapy.

Primary Outcome Measure

Mean change from baseline in BCVA at Month 8 [ Time Frame: Month 8 ]

Locations (14)

FacilityCityStateZIPSite coordinators
-PhoenixArizona--
-BakersfieldCalifornia--
-Walnut CreekCalifornia--
-GoldenColorado--
-Altamonte SpringsFlorida--
-Fort MyersFlorida--
-IndianapolisIndiana--
-PortsmouthNew Hampshire--
-CharlotteNorth Carolina--
-DallasTexas--
-HoustonTexas--
-McAllenTexas--
-San AntonioTexas--
-Salt Lake CityUtah--

Find similar trials in Phoenix, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina

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