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NCT04918121
A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
EARLY_PHASE1 trial testing Yutiq 0.18 MG Drug Implant in Glaucoma in 5 participants. Participants enrolled and being followed up; not accepting new ones.
1 June 2027
Quick facts
| Lead sponsor | Sanjay Asrani |
|---|---|
| Phase | EARLY_PHASE1 |
| Status | Active, enrolled |
| Study type | INTERVENTIONAL |
| Allocation | non randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 5 |
| Start date | 20 July 2021 |
| Primary completion | 1 June 2027 |
| Estimated completion | 1 June 2027 |
| Sites | 1 location across United States |
Drugs / interventions tested
- Yutiq 0.18 MG Drug Implant — full drug profile →
Conditions studied
- Glaucoma — all drugs for Glaucoma →
Sponsor
Sanjay Asrani
Who can join
18 and older, any sex, with Glaucoma. Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
-
Change in IOP measured using Goldman applanation tonometry
Time frame: week 12, month 6, month 12, month 18, month 24, month 30 , month 36
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert -
Change in IOP measured using tonopen/Icare
Time frame: week 12, month 6, month 12, month 18, month 24, month 30 , month 36
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert -
Medications usage as measured by medical record abstraction
Time frame: week 12
Number of medications to control IOP in the study eye -
Medications usage by medical record abstraction
Time frame: month 6
Number of medications to control IOP in the study eye -
Medications usage by medical record abstraction
Time frame: month 12
Number of medications to control IOP in the study eye -
Medications usage by medical record abstraction
Time frame: month 18
Number of medications to control IOP in the study eye
Sponsor's own description
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.
Publications & conference data
No peer-reviewed publications indexed yet for this trial.
Verify or expand the search:
- PubMed search for NCT04918121
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT04918121 (US National Library of Medicine, public domain)
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Sanjay Asrani
- Last refreshed: 6 November 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT04918121.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing