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NCT07228559TerminatedPhase 1

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

Source: ClinicalTrials.gov · Last updated 11 May 2026

Brief summary (registry, in English)

The goal of this study is to assess the safety and therapeutic potential of a single dose of avoralstat in adult participants with DME.

Status (registry)
Terminated
Phase (registry)
Phase 1
Study type
Interventional
Enrollment
3 (actual)
First submitted
26 Sept 2025
Start date
2 Oct 2025
Primary completion date
17 Apr 2026
Lead sponsor
BioCryst Pharmaceuticals
NCT number
NCT07228559

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Participants who have previously received more than 3 anti-VEGF injections
  • 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
  • Intraocular surgery ≤ 3 months prior to screening or anticipated need for ocular surgery in the study eye during the study period

Other illness

  • 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
  • Active intraocular or periocular infection or active intraocular inflammation in the study eye

Who the study is looking for

  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (8)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
-AdelaideAustraliaUnknown status
-MelbourneAustraliaUnknown status
-SydneyAustraliaUnknown status
-SydneyAustraliaUnknown status
-SydneyAustraliaUnknown status
-KatyUnited StatesUnknown status
-SacramentoUnited StatesUnknown status
-The WoodlandsUnited StatesUnknown status

Are you the coordinator? Confirm the details

This page is information, not medical advice. Discuss any trial with your doctor.