Efficacy and Safety Study of ESBA1008 Versus EYLEA®

Sponsor
Alcon Research
Study ID
NCT01796964
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
    For intravitreal (IVT) injection
  • Aflibercept — DRUG
    For intravitreal (IVT) injection

Study Details

The purpose of this study is to compare the efficacy and safety of ESBA1008 versus EYLEA® in the treatment of exudative age-related macular degeneration.

Key Dates

Start date
Mar 31, 2013
Status verified
Jan 2016
Primary completion
Oct 31, 2013
Completion
Aug 31, 2014

Study Design

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

Arms

  • Experimental: ESBA1008
    ESBA1008 solution, 7 intravitreal (IVT) injections, as specified in protocol
  • Active Comparator: EYLEA
    Aflibercept, 8 intravitreal (IVT) injections, as specified in protocol

Primary Outcome Measure

Best-Corrected Visual Acuity (BCVA) Change From Baseline (No. of Letters) to Week 12 [ Time Frame: Baseline (Day 0), Week 12 ]