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.

Study Overview

• Status: Recruiting
• Conditions: Glaucoma
• Intervention / Treatment: Drug: Yutiq 0.18 MG Drug Implant

• Study Type: Interventional
• Enrollment (Estimated): 5
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Sarah Jones; Phone Number: 1-919-681-6584; Email: sarah.jones1@duke.edu

Study Locations

• United States
  • North Carolina
    • Durham, North Carolina, United States, 27710
      • Recruiting
      • Duke Eye Center
      • Contact: Sanjay Asrani, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. At least 18 years old at time of consent.
2. Patient being consented for either glaucoma tube implant surgery in pseudophakic eyes or being consented for cataract surgery with glaucoma tube implant surgery.
3. Diagnosis of any type of glaucoma except inflammation associated glaucomas such as with co-existing uveitis or neovascular glaucoma.
4. Negative urine pregnancy test at baseline for women of childbearing potential.
5. 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:

1. Allergy to corticosteroids or any component of Yutiq insert.
2. Patients with active or suspected ocular or periocular infections including most viral diseases such as herpes simplex, vaccinia, varicella, mycobacterial infections and fungal diseases.
3. History of systemic immunosuppressive therapy or the possible need thereof such as patients with rheumatoid arthritis, lupus or transplant (systemic or eye)
4. Previous history of tube erosion in the same or the other eye
5. Eyes receiving anti-VEGF therapy in the study eye
6. Media opacity precluding evaluation of retina and optic nerve in the study eye.
7. History of steroid induced glaucoma
8. Ocular surgery in the study eye within 3 months prior to enrollment.
9. Patients who have tested positive for human immune deficiency virus.
10. Pregnant or lactating females or females of child bearing age who are not willing to use contraception for the duration of the study.
11. Patients for whom any of the protocol procedures may pose a special risk not outweighed by the potential benefits of participating in the study.
12. Patients who are unlikely to comply with the study protocol.
13. 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.
14. Treatment with an investigational drug or device within 30 days preceding the glaucoma surgery.
15. 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).

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Yutiq; A sustained-release steroid insert (Yutiq) will 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.	Drug: Yutiq 0.18 MG Drug Implant; a sustained-release steroid insert (Yutiq)
No Intervention: Control; Non-study eye will not receive the Yutiq insert

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in IOP measured using Goldman applanation tonometry	IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert	week 12, month 6, month 12, month 18, month 24, month 30 , month 36
Change in IOP measured using tonopen/Icare	IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert	week 12, month 6, month 12, month 18, month 24, month 30 , month 36
Medications usage as measured by medical record abstraction	Number of medications to control IOP in the study eye	week 12
Medications usage by medical record abstraction	Number of medications to control IOP in the study eye	month 6
Medications usage by medical record abstraction	Number of medications to control IOP in the study eye	month 12
Medications usage by medical record abstraction	Number of medications to control IOP in the study eye	month 18
Medications usage by medical record abstraction	Number of medications to control IOP in the study eye	month 24
Medications usage by medical record abstraction	Number of medications to control IOP in the study eye	month 30
Medications usage by medical record abstraction	Number of medications to control IOP in the study eye	month 36
Days on Steroid therapy by medical record abstraction	Total number of days of topical steroid therapy postoperatively	week 12
Days on Steroid therapy by medical record abstraction	Total number of days of topical steroid therapy postoperatively	month 6
Days on Steroid therapy by medical record abstraction	Total number of days of topical steroid therapy postoperatively	month 12
Days on Steroid therapy by medical record abstraction	Total number of days of topical steroid therapy postoperatively	month 18
Days on Steroid therapy by medical record abstraction	Total number of days of topical steroid therapy postoperatively	month 24
Days on Steroid therapy by medical record abstraction	Total number of days of topical steroid therapy postoperatively	month 30
Days on Steroid therapy by medical record abstraction	Total number of days of topical steroid therapy postoperatively	month 36

Collaborators and Investigators

• Sponsor: Sanjay Asrani
• Investigators: Principal Investigator: Sanjay Asrani, MD, Duke Eye Center

Study record dates

Study Major Dates

• Study Start (Actual): July 20, 2021
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): December 1, 2024

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 2, 2021
• First Posted (Actual): June 8, 2021

Study Record Updates

• Last Update Posted (Actual): September 22, 2023
• Last Update Submitted That Met QC Criteria: September 21, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Ocular Hypertension; Glaucoma
• Other Study ID Numbers: Pro00106901

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No