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RECRUITINGPHASE1

A Study of Avoralstat In Participants With Diabetic Macular Edema

A Phase 1b Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of a Suprachoroidal Injection of Avoralstat In Participants With Diabetic Macular Edema

NCT07228559•BioCryst Pharmaceuticals

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

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

Locations (8)

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

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

Key Dates

Start Date

October 2, 2025

Primary Completion Date

May 1, 2026

Completion Date

September 1, 2026

Last Updated

February 4, 2026

Enrollment

ESTIMATED participants

Conditions

Diabetic Macular Edema (DME)

Interventions

avoralstat

DRUG

Contacts

BioCryst Pharmaceuticals, Inc.

CONTACT

+1 919 859 1302 clinicaltrials@biocryst.com

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 4, 2026Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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A Study of Avoralstat In Participants With Diabetic Macular Edema

Inclusion Criteria

Exclusion Criteria

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