A Phase 1b Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Suprachoroidal Injection of Avoralstat In Participants With Diabetic Macular Edema
Status: Recruiting
Location: See all (5) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• Male or female aged 18 years or older
• Glycated hemoglobin A (HbA1c) \< 10% at screening
• Diagnosis of DME with center involvement requiring medical treatment within 6 months of screening and decreased visual acuity attributable to DME
• Mild-to-severe non-proliferative diabetic retinopathy (NPDR) with DRSS \< 61 in the study eye at screening
• BCVA between 35 and 80 ETDRS letters (20/25 to 20/200 Snellen equivalent), inclusive, in the study eye at screening
• CST measured by Heidelberg OCT between 325 and 600 μm in the study eye at screening
Locations
Other Locations
Australia
Investigative Site 4
RECRUITING
Adelaide
Investigative Site 5
RECRUITING
Melbourne
Investigative Site 1
RECRUITING
Sydney
Investigative Site 2
RECRUITING
Sydney
Investigative Site 3
RECRUITING
Sydney
Contact Information
Primary
BioCryst Pharmaceuticals, Inc.
clinicaltrials@biocryst.com
+1 919 859 1302
Time Frame
Start Date: 2025-10-02
Estimated Completion Date: 2026-09
Participants
Target number of participants: 9
Treatments
Experimental: Single dose suprachoroidal injection of avoralstat
Related Therapeutic Areas
Sponsors
Leads: BioCryst Pharmaceuticals