A Study of Avoralstat In Participants With Diabetic Macular Edema
NCT ID: NCT07228559
Last Updated: 2026-02-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
9 participants
INTERVENTIONAL
2025-10-02
2026-09-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
A Single Ascending Dose Cohort Study of AG-73305 in DME Patients
NCT05301751
Phase 1 Study of VEGF Trap in Patients With Diabetic Macular Edema
NCT00320814
DME And VEGF Trap-Eye [Intravitreal Aflibercept Injection (IAI;EYLEA®;BAY86-5321)] INvestigation of Clinical Impact
NCT00789477
Safety and Efficacy of a New Treatment in Vitrectomized Subjects With Diabetic Macular Edema
NCT00799227
Efficacy and Safety of VEGF Trap Eye in Diabetic Macular Edema (DME) With Central Involvement
NCT01783886
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single dose suprachoroidal injection of avoralstat
avoralstat
BCX4161 for suprachoroidal injection
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
avoralstat
BCX4161 for suprachoroidal injection
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
Exclusion Criteria
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
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
BioCryst Pharmaceuticals
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
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
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
BCX4161-111
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.