RecruitingPhase 1NCT07228559

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

Sponsor

BioCryst Pharmaceuticals

Enrollment

9 participants

Start Date

Oct 2, 2025

Study Type

INTERVENTIONAL

Conditions

Diabetic Macular Edema (DME)

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

Min Age: 18 Years

Inclusion Criteria6

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 Criteria5

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

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