A Study of Abicipar Pegol in Patients With Diabetic Macular Edema

Part of paid clinical trials in Gilbert, Arizona.

Sponsor
Allergan
Study ID
NCT02186119
Phase
PHASE2
Status
Completed

Conditions

  • Macular Edema

Eligibility Criteria

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

Interventions

  • abicipar pegol — DRUG
    Abicipar pegol administered to the study eye by intravitreal injection at the visits noted per protocol.
  • ranibizumab — DRUG
    Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.
  • sham procedure — OTHER
    Sham procedure to the study eye at the visits noted per protocol.

Study Details

This is a safety and efficacy study of abicipar pegol in patients with diabetic macular edema.

Key Dates

First listed
Jul 10, 2014
Start date
Jul 31, 2014
Status verified
Jul 2015
Primary completion
Jun 30, 2015
Completion
Jun 30, 2015

Study Design

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

Arms

  • Experimental: abicipar pegol 2 mg (group A)
    Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, and 20, followed by a sham procedure at weeks 12, 16, and 24.
  • Experimental: abicipar pegol 2 mg (group B)
    Abicipar pegol 2 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
  • Experimental: abicipar pegol 1 mg
    Abicipar pegol 1 mg administered to the study eye by intravitreal injection at day 1, weeks 4, 8, 16, and 24, followed by a sham procedure at weeks 12 and 20.
  • Active Comparator: ranibizumab
    Ranibizumab (Lucentis®) administered to the study eye by intravitreal injection every 4 weeks from day 1 through week 24.

Primary Outcome Measure

Change from Baseline in Best Corrected Visual Acuity (BCVA) [ Time Frame: Baseline, Week 28 ]

Locations (2)

FacilityCityStateZIPSite coordinators
-GilbertArizona--
-AbileneTexas--

Related Studies