A Study of Abicipar Pegol in Patients With Neovascular Age-related Macular Degeneration

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Allergan
Study ID
NCT02181517
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • abicipar pegol — DRUG
    Abicipar pegol administered to the study eye by intravitreal injection at day 1, weeks 4 and 8.
  • ranibizumab — DRUG
    Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.
  • sham procedure — OTHER
    Sham procedure to the study eye at weeks 12 and 16.

Study Details

This is a safety and efficacy study of abicipar pegol in patients with neovascular age-related macular degeneration to establish comparability between Japanese and non-Japanese.

Key Dates

First listed
Jul 4, 2014
Start date
Jul 31, 2014
Status verified
Apr 2016
Primary completion
Mar 31, 2015
Completion
Mar 31, 2015

Study Design

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

Arms

  • Experimental: abicipar pegol 1 mg
    Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
  • Experimental: abicipar pegol 2 mg
    Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4 and 8, followed by a sham procedure at weeks 12 and 16.
  • Active Comparator: ranibizumab 0.5 mg
    Ranibizumab (Lucentis®) 0.5 mg administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 16.

Primary Outcome Measure

Change From Baseline in Best Corrected Visual Acuity (BCVA) in the Study Eye at Week 16 Using the Early Treatment Diabetic Retinopathy Study (ETDRS) Scale [ Time Frame: Baseline, Week 16 ]

Locations (1)

FacilityCityStateZIPSite coordinators
-PhoenixArizona--

Find similar trials in Phoenix, AZ

By condition
Age-related macular degeneration
By specialty
OphthalmologyRetina

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