Active — Not RecruitingPhase 1

A Study of Avoralstat In Participants With Diabetic Macular Edema

United States, Australia9 participantsStarted 2025-10-02

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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

Exclusion criteria

✕. Participants who have previously received more than 3 anti-VEGF injections
✕. 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
✕. 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
✕. Active intraocular or periocular infection or active intraocular inflammation in the study eye
✕. Intraocular surgery ≤ 3 months prior to screening or anticipated need for ocular surgery in the study eye during the study period

What they're measuring

The safety and tolerability of avoralstat in participants with DME. Incidence and severity of ocular (study eye) and systemic treatment emergent adverse events (TEAEs).

Timeframe: From screening through EOS (Week 24)

Trial details

NCT IDNCT07228559

SponsorBioCryst Pharmaceuticals

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2026-05

View on ClinicalTrials.gov More Diabetic Macular Edema (DME) trials