Diabetic Macular Edema (DME)
Conditions
Keywords
single ascending dose, safety, pharmacokinetics, suprachoroidal injection
Brief summary
The goal of this study is to assess the safety and therapeutic potential of a single dose of avoralstat in adult participants with DME.
Detailed description
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.
Interventions
DRUGavoralstat
BCX4161 for suprachoroidal injection
Sponsors
BioCryst Pharmaceuticals
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or female aged 18 years or older 2. Glycated hemoglobin A (HbA1c) \< 10% at screening 3. Diagnosis of DME with center involvement requiring medical treatment within 6 months of screening and decreased visual acuity attributable to DME 4. Mild-to-severe non-proliferative diabetic retinopathy (NPDR) with DRSS \< 61 in the study eye at screening 5. BCVA between 35 and 80 ETDRS letters (20/25 to 20/200 Snellen equivalent), inclusive, in the study eye at screening 6. CST measured by Heidelberg OCT between 325 and 600 μm in the study eye at screening Key
Exclusion criteria
1. Participants who have previously received more than 3 anti-VEGF injections 2. Any history of retinal surgery or other surgical intervention for diabetic ocular complications or anticipated need for use of laser photocoagulation course of any of the procedures listed in the criteria in the study eye during the study period 3. Current medically untreated diabetes mellitus or previous medically untreated diabetes mellitus with initiation of oral or injectable anti-diabetic medication ≤ 3 months prior to screening 4. Active intraocular or periocular infection or active intraocular inflammation in the study eye 5. Intraocular surgery ≤ 3 months prior to screening or anticipated need for ocular surgery in the study eye during the study period
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The safety and tolerability of avoralstat in participants with DME. Incidence and severity of ocular (study eye) and systemic treatment emergent adverse events (TEAEs). | From screening through EOS (Week 24) |
Secondary
| Measure | Time frame |
|---|---|
| Therapeutic potential of avoralstat in participants with DME. Trends in central subfield thickness (CST) as assessed by spectral domain optical coherence tomography (SD-OCT). | 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). | From baseline through Weeks 12 and 24 |
Countries
Australia, United States
Outcome results
None listed