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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: Completed Phase 2 study, sponsored by Oxular Limited.

NCT05697809 is a Phase 2 study that has completed, run by Oxular Limited. The registered enrollment target is 3 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower). According to ClinicalTrials.gov, the official US trial registry.

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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.

Primary Outcome

Treatment-emergent adverse events are defined as events emerging following administration of study treatment (OXU-001 administered with the Oxulumis suprachoroidal administration device) at Visit 2 (Baseline, Day 0)

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
Oxular Limited

2 total trials

What the finished NCT05697809 record still lists

NCT05697809 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 3 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (98% lower).

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

NCT05697809 does not publish any study locations in the registry export this page uses.

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.

How this trial's enrollment target compares

Where NCT05697809's enrollment target sits among peer trials

3 2001st of 2000 the lowest of 2,000 other Phase 2 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT05697809, the US trial registry maintained by the National Library of Medicine. NCT05697809 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.