Diabetic Macular Edema (DME)Phase 1NCT07228559
A Study of Avoralstat In Participants With Diabetic Macular Edema
A Phase 1 study testing avoralstat in people with Diabetic Macular Edema (DME), run by BioCryst Pharmaceuticals at 8 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetic Macular Edema (DME)
- What is being tested?
- avoralstat
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 8 sitesin 2 countries
- Study dates
- 2 Oct 2025to 17 Apr 2026
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
8 sites in 2 countries.
8 sites in 2 countries
Australia5 sites
Investigative Site 4
Adelaide, South Australia
Investigative Site 5
Melbourne, Victoria
Investigative Site 1
Sydney, New South Wales
Investigative Site 2
Sydney, New South Wales
Investigative Site 3
Sydney, New South Wales
United States3 sites
Investigative Site 7
Katy, Texas, 77494
Investigative Site 6
Sacramento, California, 95825
Investigative Site 8
The Woodlands, Texas, 77384
About this study
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
The goal of this study is to assess the safety and therapeutic potential of a single dose of avoralstat in adult participants with DME.
Read the 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.
- Conditions
- Diabetic Macular Edema (DME)
- Being tested
- avoralstat
- Keywords
- single ascending dose, safety, pharmacokinetics, suprachoroidal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
avoralstatDrug
BCX4161 for suprachoroidal injection
| Study group | Role | What they receive |
|---|---|---|
| Single dose suprachoroidal injection of avoralstat | Experimental | Not described Receives: Drug: avoralstat |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety and tolerability of avoralstat in participants with DME. Incidence and severity of ocular (study eye) and systemic treatment emergent adverse events (TEAEs).
Measured: From screening through EOS (Week 24)
Secondary outcomes (2)
Therapeutic potential of avoralstat in participants with DME. Trends in central subfield thickness (CST) as assessed by spectral domain optical coherence tomography (SD-OCT).
Measured: 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).
Measured: From baseline through Weeks 12 and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Nov 2025
- Study start2 Oct 2025
- Primary completion17 Apr 2026
- Study completion17 Apr 2026
Why it stopped: Strategic decision
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic Macular Edema (DME)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- BioCryst Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07228559
- Sponsor's protocol ID
- BCX4161-111
- Status last verified
- May 2026
- First submitted
- 26 Sep 2025
- Last updated
- 11 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07228559
- Acronym / sponsor ID
- BCX4161-111
- Conditions
- Diabetic Macular Edema (DME)
- Keywords
- single ascending dose, safety, pharmacokinetics, suprachoroidal injection
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Strategic decision
- Enrolment
- 3 participants (actual)
- Lead sponsor
- BioCryst PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Oct 2025 (actual)
- Primary completion
- 17 Apr 2026 (actual)
- Study completion
- 17 Apr 2026 (actual)
- First posted
- 14 Nov 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single dose suprachoroidal injection of avoralstat | Experimental | Drug: avoralstat |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| avoralstatBCX4161 for suprachoroidal injection | Drug | Single dose suprachoroidal injection of avoralstat |
Primary outcome
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)
2 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
Results and safety
The study was stopped early (reason given: Strategic decision). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing avoralstat in people with Diabetic Macular Edema (DME), run by BioCryst Pharmaceuticals at 8 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Australia, United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Strategic decision). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 May 2026.