A Study to Evaluate ASP8232 in Reducing Central Retinal Thickness in Subjects With Diabetic Macular Edema (DME)

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Astellas Pharma Europe B.V.
Study ID
NCT02302079
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 85 Years
Healthy Volunteers
Not accepted

Interventions

  • ASP8232 — DRUG
    oral capsule
  • ranibizumab — DRUG
    intravitreal (IVT) injection
  • Placebo — DRUG
    oral capsule
  • Sham intravitreal (IVT) injection — OTHER
    intravitreal (IVT) injection

Study Details

The purpose of this study is to evaluate efficacy and safety of ASP8232 in subjects with diabetic macular edema (DME). This study will evaluate the percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence Tomography (SD-OCT) for ASP8232 monotherapy at Month 3.

Key Dates

First listed
Nov 26, 2014
Start date
Jan 12, 2015
Status verified
Oct 2024
Primary completion
Aug 12, 2016
Completion
Aug 12, 2016

Study Design

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

Arms

  • Experimental: ASP8232 + sham intravitreal (IVT) injections
    ASP8232 will be given orally once daily and sham injections 3 times with 1 month intervals
  • Experimental: ASP8232 + ranibizumab intravitreal (IVT) injections
    ASP8232 will be given orally once daily and ranibizumab injections 3 times with 1 month intervals
  • Active Comparator: Placebo + ranibizumab intravitreal (IVT) injections
    Placebo will be given orally once daily and ranibizumab injections 3 times with 1 month intervals

Primary Outcome Measure

Percent change from baseline in excess central subfield thickness (CST) in the study eye as assessed by spectral domain-optical coherence tomography (SD-OCT) at Month 3 [ Time Frame: Baseline and Month 3 ]

Locations (21)

FacilityCityStateZIPSite coordinators
Site US10021PhoenixArizona85104-
Site US10025TucsonArizona85704-
Site US10006ArcadiaCalifornia91007-
Site US10004Beverly HillsCalifornia90211-
Site US10007Palm DesertCalifornia92260-
Site US10011SacramentoCalifornia95819-
Site US10031Santa AnaCalifornia92705-
Site US10029GoldenColorado80401-
Site US10016MiamiFlorida33126-
Site US10005Winter HavenFlorida33880-
Site US10036AugustaGeorgia30909-
Site US10002BostonMassachusetts02114-
Site US10001OmahaNebraska985540-
Site US10027RenoNevada89511-
Site US10012NashvilleTennessee37203-
Site US10010AbileneTexas79606-
Site US10015AustinTexas78705-
Site US10013HoustonTexas77030-
Site US10030McAllenTexas78503-
Site US10009San AntonioTexas78240-1502-
Site US10017CharlottesvilleVirginia22903-

Find similar trials in Phoenix, AZ

By condition
Diabetic retinopathy
By specialty
OphthalmologyRetina
By research site
Site US10021· Phoenix, AZSite US10025· Tucson, AZSite US10006· Arcadia, CASite US10004· Beverly Hills, CASite US10007· Palm Desert, CASite US10011· Sacramento, CA

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