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NCT05512962 · ClinicalTrials.gov registry record · Phase 2
Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema
A Phase 2 study of Diabetic Macular Edema, sponsored by Oxular Limited.
- Completed
- Registry status
- Phase 2
- Development phase
- 25
- Enrollment target
- 6
- Study locations
NCT05512962: Completed Phase 2 study of Diabetic Macular Edema, sponsored by Oxular Limited.
NCT05512962 is a Phase 2 study of Diabetic Macular Edema that has completed, run by Oxular Limited. The registered enrollment target is 25 participants, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower). The trial reports 6 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05512962, a Phase 2 study of Diabetic Macular Edema, has completed, sponsored by Oxular Limited.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 25 participants
- Enrollment target
- 6
- Study locations
Study Summary
The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema.
Primary Outcome
Treatment-emergent ocular adverse events are defined as an ocular event that emerges following the start of administration of Triesence® with the Oxulumis® microcatheter at Visit 2 (Baseline, Day 0)
Conditions Studied
Interventions
- DRUG Triamcinolone Acetonide
- DEVICE Semi-automated Suprachoroidal Microcatheter
Study Locations (6)
Texas
- Austin Retina Associates - Austin
- Retina Consultants of Texas - The Woodlands - Houston
- Retina Consultants of Texas - Bellaire - Houston
- Retina Consultants of Texas - San Antonio - San Antonio
California
- California Retina Consultants - Bakersfield
Minnesota
- Retina Consultants of Minnesota - Minneapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 25 participants |
| Start Date | 2022-08-31 |
| Est. Completion | 2023-11-30 |
| Phase | Phase 2 |
What the finished NCT05512962 record still lists
NCT05512962 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 25 participants, a relatively small participant target, below the 3,794-participant average among 63 other Diabetic Macular Edema trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Diabetic Macular Edema appearing as the primary indexed condition, and to 2 interventions - of which Triamcinolone Acetonide is the first listed.
NCT05512962 lists 6 locations in 3 states (Texas, California, Minnesota).
Frequently Asked Questions
What is clinical trial NCT05512962 about?
NCT05512962 is a clinical study titled "Oxulumis® Suprachoroidal Microcatherization of Triesence® in Diabetic Macular Edema". The purpose of this clinical trial is to evaluate the safety and tolerability of suprachoroidal microcatheterization with the Oxulumis® device for a randomized treatment with two dose levels of Triesence® in subjects with Diabetic Macular Edema.
What is the current status of trial NCT05512962?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 25 participants. The study started on 2022-08-31. Estimated completion is 2023-11-30.
What conditions does trial NCT05512962 study?
This clinical trial studies the following conditions: Diabetic Macular Edema.
What interventions are being tested in trial NCT05512962?
The interventions under investigation include: Triamcinolone Acetonide (DRUG), Semi-automated Suprachoroidal Microcatheter (DEVICE).
Who is sponsoring clinical trial NCT05512962?
This trial is sponsored by Oxular Limited, which has 2 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05512962 being conducted?
This trial has 6 study locations across California, Minnesota, Texas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Diabetic Macular Edema
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05512962's enrollment target sits among peer trials
25 49th of 63 higher than 14 of 63 other Diabetic Macular Edema trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Diabetic Macular Edema 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.
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