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NCT04918121 · ClinicalTrials.gov registry record · Early Phase 1
A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
A Early Phase 1 study of Glaucoma, sponsored by Sanjay Asrani.
- Active
- Registry status
- Early Phase 1
- Development phase
- 5
- Enrollment target
- 1
- Study location
NCT04918121: Active Early Phase 1 study of Glaucoma, sponsored by Sanjay Asrani.
NCT04918121 is a Early Phase 1 study of Glaucoma that is active but no longer recruiting, run by Sanjay Asrani. The registered enrollment target is 5 participants, below the 911-participant average among 92 other Glaucoma trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04918121, a Early Phase 1 study of Glaucoma, is active but no longer recruiting, sponsored by Sanjay Asrani.
- ACTIVE NOT RECRUITING
- Registry status
- Early Phase 1
- Development phase
- 5 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a pilot study, which will include approximately five eyes of 5 patients. This study proposes that a sustained release steroid insert (Yutiq)1 be implanted along with a glaucoma drainage device (Ahmed Glaucoma Valve (AGV) Model FP7) when the patient is undergoing glaucoma tube implant surgery or combined glaucoma tube implant and cataract surgery. The primary aim of this study is to assess the safety and efficacy (controlling intraocular pressure) of the Yutiq inserts to reduce post-operative scarring in surgical glaucoma patients. It is expected that post-operative week 12 onwards there will be a clinically and statistically significant lower IOP in the study eyes than eyes in a group undergoing the same surgery without the Yutiq insert. The estimated duration of the present study is 3 years.
Primary Outcome
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert
Conditions Studied
Interventions
- DRUG Yutiq 0.18 MG Drug Implant
Study Locations (1)
North Carolina
- Duke Eye Center - Durham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 5 participants |
| Start Date | 2021-07-20 |
| Est. Completion | 2027-06 |
| Phase | Early Phase 1 |
What the registry record for NCT04918121 still lists
NCT04918121 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 5 participants, a relatively small participant target, below the 911-participant average among 92 other Glaucoma trials with a reported enrollment target (99% lower).
The record links to 1 condition, with Glaucoma appearing as the primary indexed condition, and to 1 intervention - of which Yutiq 0.18 MG Drug Implant is the first listed.
NCT04918121 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04918121 about?
NCT04918121 is a clinical study titled "A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery". This is a pilot study, which will include approximately five eyes of 5 patients. This study proposes that a sustained release steroid insert (Yutiq)1 be implanted along with a glaucoma drainage device (Ahmed Glaucoma Valve (AGV) Model FP7) when the patient is undergoing glaucoma tube implant surgery...
What is the current status of trial NCT04918121?
This trial is currently active not recruiting. It is a Early Phase 1 study. The enrollment target is 5 participants. The study started on 2021-07-20. Estimated completion is 2027-06.
What conditions does trial NCT04918121 study?
This clinical trial studies the following conditions: Glaucoma.
What interventions are being tested in trial NCT04918121?
The interventions under investigation include: Yutiq 0.18 MG Drug Implant (DRUG).
Who is sponsoring clinical trial NCT04918121?
This trial is sponsored by Sanjay Asrani, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04918121 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Glaucoma
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 NCT04918121's enrollment target sits among peer trials
5 92nd of 92 higher than 1 of 92 other Glaucoma trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Glaucoma 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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