---
title: A Study of Avoralstat In Participants With Diabetic Macular Edema
nct_id: NCT07228559
overall_status: TERMINATED
phase: PHASE1
sponsor: BioCryst Pharmaceuticals
study_type: INTERVENTIONAL
primary_condition: Diabetic Macular Edema (DME)
countries: United States, Australia
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07228559.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07228559"
ct_last_update_post_date: 2026-05-11
last_seen_at: "2026-05-12T06:57:35.085Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Study of Avoralstat In Participants With Diabetic Macular Edema

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

**NCT ID:** [NCT07228559](https://clinicaltrials.gov/study/NCT07228559)

## Key Facts

- **Status:** TERMINATED
- **Why Stopped:** Strategic decision
- **Phase:** PHASE1
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 3
- **Lead Sponsor:** BioCryst Pharmaceuticals
- **Conditions:** Diabetic Macular Edema (DME)
- **Start Date:** 2025-10-02
- **Completion Date:** 2026-04-17
- **CT.gov Last Update:** 2026-05-11

## Brief 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

- **Minimum age:** 18 Years
- **Sex:** ALL
- **Healthy Volunteers:** No

```
Key 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

Key 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
```

## Arms

- **Single dose suprachoroidal injection of avoralstat** (EXPERIMENTAL)

## Interventions

- **avoralstat** (DRUG) — BCX4161 for suprachoroidal injection

## Primary Outcomes

- **The safety and tolerability of avoralstat in participants with DME. Incidence and severity of ocular (study eye) and systemic treatment emergent adverse events (TEAEs).** _(time frame: From screening through EOS (Week 24))_

## Secondary Outcomes

- **Therapeutic potential of avoralstat in participants with DME. Trends in central subfield thickness (CST) as assessed by spectral domain optical coherence tomography (SD-OCT).** _(time frame: From baseline through Weeks 12 and 24)_
- **Therapeutic potential of avoralstat in participants with DME. Trends in Early Treatment Diabetic Retinopathy Study (ETDRS) Best Corrected Visual Acuity (BCVA).** _(time frame: From baseline through Weeks 12 and 24)_

## 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

## Recent Field Changes (last 30 days)

- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `status.overallStatus` — added _(2026-05-12)_
- `status.whyStopped` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `locations.investigative site 6|sacramento|california|united states` — added _(2026-05-12)_
- `locations.investigative site 7|katy|texas|united states` — added _(2026-05-12)_
- `locations.investigative site 8|the woodlands|texas|united states` — added _(2026-05-12)_
- `locations.investigative site 1|sydney|new south wales|australia` — added _(2026-05-12)_
- `locations.investigative site 2|sydney|new south wales|australia` — added _(2026-05-12)_
- `locations.investigative site 3|sydney|new south wales|australia` — added _(2026-05-12)_
- `locations.investigative site 4|adelaide|south australia|australia` — added _(2026-05-12)_
- `locations.investigative site 5|melbourne|victoria|australia` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT07228559*  
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