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
9
BCX4161 for suprachoroidal injection
Investigative Site 6
Sacramento, California, United States
RECRUITINGInvestigative Site 7
Katy, Texas, United States
RECRUITINGInvestigative Site 8
The Woodlands, Texas, United States
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 1
Sydney, New South Wales, Australia
RECRUITINGInvestigative Site 2
Sydney, New South Wales, Australia
RECRUITINGInvestigative Site 3
Sydney, New South Wales, Australia
RECRUITINGInvestigative Site 4
Adelaide, South Australia, Australia
RECRUITINGInvestigative Site 5
Melbourne, Victoria, Australia
RECRUITING