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Yutiq Steroid Insert for Glaucoma

Phase < 1
Recruiting
Led By Sanjay Asrani, MD
Research Sponsored by Sanjay Asrani
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 12, month 6, month 12, month 18, month 24, month 30 , month 36
Awards & highlights

Study Summary

This trial will study the use of a sustained release steroid insert to help control intraocular pressure and reduce scarring in patients who have glaucoma surgery.

Who is the study for?
This trial is for adults over 18 with glaucoma, except those with inflammation-related types like uveitis. It's for patients planning to have glaucoma tube implant surgery or combined cataract and glaucoma surgery. Participants must not be pregnant, willing to follow the study plan, and able to give informed consent.Check my eligibility
What is being tested?
The study tests if a Yutiq steroid insert can safely control eye pressure and reduce scarring when implanted during glaucoma tube implant surgery. The goal is to see if there's a significant difference in eye pressure after 12 weeks compared to surgeries without Yutiq.See study design
What are the potential side effects?
Potential side effects of the Yutiq insert may include increased risk of infection, possible allergic reactions, and complications related to steroid use such as elevated eye pressure.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18 years old or older.
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I am scheduled for glaucoma tube implant surgery, with or without cataract surgery.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 12, month 6, month 12, month 18, month 24, month 30 , month 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 12, month 6, month 12, month 18, month 24, month 30 , month 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Change in IOP measured using Goldman applanation tonometry
Change in IOP measured using tonopen/Icare
Days on Steroid therapy by medical record abstraction
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Active Control
Group I: YutiqExperimental Treatment1 Intervention
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.
Group II: ControlActive Control1 Intervention
Non-study eye will not receive the Yutiq insert

Find a Location

Who is running the clinical trial?

Sanjay AsraniLead Sponsor
Sanjay Asrani, MDPrincipal InvestigatorDuke Eye Center
2 Previous Clinical Trials
77 Total Patients Enrolled
2 Trials studying Glaucoma
77 Patients Enrolled for Glaucoma

Media Library

Yutiq 0.18 MG Drug Implant Clinical Trial Eligibility Overview. Trial Name: NCT04918121 — Phase < 1
Glaucoma Research Study Groups: Yutiq, Control
Glaucoma Clinical Trial 2023: Yutiq 0.18 MG Drug Implant Highlights & Side Effects. Trial Name: NCT04918121 — Phase < 1
Yutiq 0.18 MG Drug Implant 2023 Treatment Timeline for Medical Study. Trial Name: NCT04918121 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is the capacity of this trial with regards to participants?

"Affirmative. Clinicaltrials.gov documents show that this research endeavor, which was published on July 20th 2021, is actively searching for participants. Around 5 individuals are needed from a single medical centre to participate in the trial."

Answered by AI

Are there still opportunities for enrollment in this research project?

"Affirmative. As per the data on clinicaltrials.gov, this research venture is enrolling subjects right now. It was first published on July 20th 2021 and updated most recently September 8th 2022. The team needs a total of 5 individuals from one medical site to take part in the study."

Answered by AI

What is the intended purpose of Yutiq 0.18 MG Drug Implant?

"Yutiq 0.18 MG Drug Implant can be administered to patients suffering from skin inflammation due to bacterial infection, otitis media and friction-induced wounds."

Answered by AI

Who else is applying?

What state do they live in?
South Carolina
What site did they apply to?
Duke Eye Center
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
3+
Recent research and studies
clinicaltrials.govStudy
A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
Sanjay Asrani 2021. "A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04918121.
All > Glaucoma High Point > Glaucoma
~1 spots leftby Dec 2024
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