The goal of this study is to assess the safety and therapeutic potential of a single dose of avoralstat in adult participants with DME.
Study BCX4161-111 is an open-label, single ascending dose study with 24 weeks follow-up in participants with DME. Three cohorts with a minimum of 3 participants enrolled in each cohort with 3 dose levels of avoralstat (low, medium, high) are planned.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
3
BCX4161 for suprachoroidal injection
Investigative Site 6
Sacramento, California, United States
Investigative Site 7
Katy, Texas, United States
Investigative Site 8
The Woodlands, Texas, United States
Investigative Site 1
Sydney, New South Wales, Australia
The safety and tolerability of avoralstat in participants with DME. Incidence and severity of ocular (study eye) and systemic treatment emergent adverse events (TEAEs).
Time frame: From screening through EOS (Week 24)
Therapeutic potential of avoralstat in participants with DME. Trends in central subfield thickness (CST) as assessed by spectral domain optical coherence tomography (SD-OCT).
Time frame: From baseline through Weeks 12 and 24
Therapeutic potential of avoralstat in participants with DME. Trends in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA).
Time frame: From baseline through Weeks 12 and 24
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Investigative Site 2
Sydney, New South Wales, Australia
Investigative Site 3
Sydney, New South Wales, Australia
Investigative Site 4
Adelaide, South Australia, Australia
Investigative Site 5
Melbourne, Victoria, Australia