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NCT Number: NCT04918121

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 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.

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This study is active but is not currently recruiting participants.

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Key information

Conditions

Glaucoma Eye Diseases Ocular Hypertension

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Duke Eye Center

Durham, North Carolina, 27710, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • At least 18 years old at time of consent.
  • Patient being consented for either glaucoma tube implant surgery in pseudophakic eyes or being consented for cataract surgery with glaucoma tube implant surgery.
  • Diagnosis of any type of glaucoma except inflammation associated glaucomas such as with co-existing uveitis or neovascular glaucoma.
  • Negative urine pregnancy test at baseline for women of childbearing potential.
  • Subjects who are willing and able to comply with scheduled visits, treatment plan and other study procedures and are able to provide an informed consent document signed and dated by the subject

Exclusion criteria

  • Allergy to corticosteroids or any component of Yutiq insert.
  • Patients with active or suspected ocular or periocular infections including most viral diseases such as herpes simplex, vaccinia, varicella, mycobacterial infections and fungal diseases.
  • History of systemic immunosuppressive therapy or the possible need thereof such as patients with rheumatoid arthritis, lupus or transplant (systemic or eye)
  • Previous history of tube erosion in the same or the other eye
  • Eyes receiving anti-VEGF therapy in the study eye
  • Media opacity precluding evaluation of retina and optic nerve in the study eye.
  • History of steroid induced glaucoma
  • Ocular surgery in the study eye within 3 months prior to enrollment.
  • Patients who have tested positive for human immune deficiency virus.
  • Pregnant or lactating females or females of child bearing age who are not willing to use contraception for the duration of the study.
  • Patients for whom any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study.
  • Patients who are unlikely to comply with the study protocol.
  • Any severe acute or chronic medical or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and, in the judgment of the investigator, could make the patient inappropriate for entry into this study.
  • Treatment with an investigational drug or device within 30 days preceding the glaucoma surgery.
  • Any eye needing urgent glaucoma surgery i.e. within 5 days of the baseline visit (to allow time for patients to review the study documents).

Treatment and study plan

Yutiq 0.18 MG Drug Implant

Drug

a sustained-release steroid insert (Yutiq)

Primary outcomes

  1. 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

  2. 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

  3. Medications usage as measured by medical record abstraction

    Time frame: week 12

    Number of medications to control IOP in the study eye

  4. Medications usage by medical record abstraction

    Time frame: month 6

    Number of medications to control IOP in the study eye

  5. Medications usage by medical record abstraction

    Time frame: month 12

    Number of medications to control IOP in the study eye

  6. Medications usage by medical record abstraction

    Time frame: month 18

    Number of medications to control IOP in the study eye

  7. Medications usage by medical record abstraction

    Time frame: month 24

    Number of medications to control IOP in the study eye

  8. Medications usage by medical record abstraction

    Time frame: month 30

    Number of medications to control IOP in the study eye

  9. Medications usage by medical record abstraction

    Time frame: month 36

    Number of medications to control IOP in the study eye

  10. Days on Steroid therapy by medical record abstraction

    Time frame: week 12

    Total number of days of topical steroid therapy postoperatively

  11. Days on Steroid therapy by medical record abstraction

    Time frame: month 6

    Total number of days of topical steroid therapy postoperatively

  12. Days on Steroid therapy by medical record abstraction

    Time frame: month 12

    Total number of days of topical steroid therapy postoperatively

  13. Days on Steroid therapy by medical record abstraction

    Time frame: month 18

    Total number of days of topical steroid therapy postoperatively

  14. Days on Steroid therapy by medical record abstraction

    Time frame: month 24

    Total number of days of topical steroid therapy postoperatively

  15. Days on Steroid therapy by medical record abstraction

    Time frame: month 30

    Total number of days of topical steroid therapy postoperatively

  16. Days on Steroid therapy by medical record abstraction

    Time frame: month 36

    Total number of days of topical steroid therapy postoperatively

Sponsors and collaborators

Lead sponsor

Sanjay Asrani

Other

Registry information

Important dates

Study start
2021
Primary completion
2027
Study completion
2027
First posted
Jun 8, 2021
Registry last updated
Nov 10, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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