ESBA1008 Microvolume Study

Sponsor
Alcon Research
Study ID
NCT01849692
Phase
PHASE2
Status
Completed

Conditions

  • Exudative Age-Related Macular Degeneration

Eligibility Criteria

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

Interventions

  • ESBA1008 solution — DRUG
    Intravitreal injection or infusion
  • Ranibizumab — DRUG
    Intravitreal injection

Study Details

The purpose of this study is to demonstrate a treatment effect of ESBA1008 applied as a microvolume injection or infusion on retinal function and morphology in subjects with exudative age-related macular degeneration (AMD).

Key Dates

First listed
May 8, 2013
Start date
Jun 30, 2013
Status verified
Jan 2016
Primary completion
Jan 31, 2015
Completion
Jan 31, 2015

Study Design

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

Arms

  • Experimental: ESBA1008 1.2 mg/10 μL
    Cohort 1: One intravitreal injection on Day 0, followed by one intravitreal (IVT) injection of ESBA1008 6 mg/50 μL on Day 28
  • Experimental: ESBA1008 1 mg/8.3 μL
    Cohort 2: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28
  • Experimental: ESBA1008 0.6 mg/10 μL
    Cohort 3: One intravitreal injection on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28
  • Experimental: ESBA1008 0.5 mg/8.3 μL
    Cohort 4: One intravitreal infusion on Day 0, followed by one intravitreal injection of ESBA1008 6 mg/50 μL on Day 28
  • Active Comparator: Ranibizumab 0.5 mg in 50 μL
    Cohorts 1-4: One intravitreal injection on Day 0, followed by another intravitreal injection on Day 28

Primary Outcome Measure

Percentage of Responders Based on CSFT and BCVA Outcomes at Day 14 and Day 28 [ Time Frame: Baseline, Day 14, Day 28 ]