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Eye injection study for diabetes-related vision loss ends early

NCT ID NCT07228559

Disease control Sponsor: BioCryst Pharmaceuticals Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested a single injection of avoralstat into the eye for people with diabetic macular edema, a condition that causes vision loss in diabetes. Only 3 adults took part before the study was stopped early. The main goal was to check safety and see if the drug might help reduce swelling in the retina.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 1

The first testing in people. Mainly checks safety and dose, usually in a small group.

Participants

3 people

The number who actually took part.

Started

Oct 2025

Finished

Apr 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetic macular edema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic macular edema (DME)

Contacts and locations

Locations

  • 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

  • Investigative Site 6

    Sacramento, California, 95825, United States

  • Investigative Site 7

    Katy, Texas, 77494, United States

  • Investigative Site 8

    The Woodlands, Texas, 77384, United States

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