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NCT05697809 · ClinicalTrials.gov registry record · Phase 2

Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema

A Phase 2 study, sponsored by Oxular Limited.

Completed
Registry status
Phase 2
Development phase
3
Enrollment target

NCT05697809 is a Phase 2 study that has completed, run by Oxular Limited. The registered enrollment target is 3 participants.

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The verdict

NCT05697809, a Phase 2 study, has completed, sponsored by Oxular Limited.

COMPLETED
Registry status
Phase 2
Development phase
3 participants
Enrollment target

Study Summary

The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis® illuminated microcatheterization device compared with intravitreal dexamethasone implant (OZURDEX®) in subjects with diabetic macular edema.

Interventions

  • DRUG OXU-001
  • DEVICE Semi-automated suprachoroidal illuminated microcatheter
  • DRUG Ozurdex® Ophthalmic Intravitreal Implant

Trial Details

FieldValue
Enrollment Target 3 participants
Start Date 2023-08-07
Est. Completion 2024-12-05
Phase Phase 2

Sponsor

Oxular Limited

2 total trials

What the Registry Record Tells You About NCT05697809

The ClinicalTrials.gov registry entry for NCT05697809 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 3 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Oxular Limited, which has 2 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 3 interventions - of which OXU-001 is the first listed.

NCT05697809 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT05697809 about?

NCT05697809 is a clinical study titled "Suprachoroidal Sustained-Release OXU-001 Compared to Intravitreal Ozurdex® in the Treatment of Diabetic Macular Edema". The purpose of this clinical trial is to compare safety, tolerability, efficacy, and durability of two dose levels of suprachoroidal sustained-release OXU-001 (dexamethasone microspheres; DEXAspheres®) using the Oxulumis® illuminated microcatheterization device compared with intravitreal dexamethaso...

What is the current status of trial NCT05697809?

This trial is currently completed. It is a Phase 2 study. The enrollment target is 3 participants. The study started on 2023-08-07. Estimated completion is 2024-12-05.

What interventions are being tested in trial NCT05697809?

The interventions under investigation include: OXU-001 (DRUG), Semi-automated suprachoroidal illuminated microcatheter (DEVICE), Ozurdex® Ophthalmic Intravitreal Implant (DRUG).

Who is sponsoring clinical trial NCT05697809?

This trial is sponsored by Oxular Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.