Back to resultsA Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
Primary Purpose
Glaucoma
Status
Recruiting
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Yutiq 0.18 MG Drug Implant
Sponsored by
About this trial
This is an interventional treatment trial for Glaucoma
Eligibility Criteria
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).
Sites / Locations
- Duke Eye CenterRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Yutiq
Control
Arm Description
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.
Non-study eye will not receive the Yutiq insert
Outcomes
Primary Outcome Measures
Change in IOP measured using Goldman applanation tonometry
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert
Change in IOP measured using tonopen/Icare
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert
Medications usage as measured by medical record abstraction
Number of medications to control IOP in the study eye
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04918121
Brief Title
A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
Official Title
A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
Study Type
Interventional
2. Study Status
Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 20, 2021 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Sanjay Asrani
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Glaucoma
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
5 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Yutiq
Arm Type
Experimental
Arm Description
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.
Arm Title
Control
Arm Type
No Intervention
Arm Description
Non-study eye will not receive the Yutiq insert
Intervention Type
Drug
Intervention Name(s)
Yutiq 0.18 MG Drug Implant
Intervention Description
a sustained-release steroid insert (Yutiq)
Primary Outcome Measure Information:
Title
Change in IOP measured using Goldman applanation tonometry
Description
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert
Time Frame
week 12, month 6, month 12, month 18, month 24, month 30 , month 36
Title
Change in IOP measured using tonopen/Icare
Description
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert
Time Frame
week 12, month 6, month 12, month 18, month 24, month 30 , month 36
Title
Medications usage as measured by medical record abstraction
Description
Number of medications to control IOP in the study eye
Time Frame
week 12
Title
Medications usage by medical record abstraction
Description
Number of medications to control IOP in the study eye
Time Frame
month 6
Title
Medications usage by medical record abstraction
Description
Number of medications to control IOP in the study eye
Time Frame
month 12
Title
Medications usage by medical record abstraction
Description
Number of medications to control IOP in the study eye
Time Frame
month 18
Title
Medications usage by medical record abstraction
Description
Number of medications to control IOP in the study eye
Time Frame
month 24
Title
Medications usage by medical record abstraction
Description
Number of medications to control IOP in the study eye
Time Frame
month 30
Title
Medications usage by medical record abstraction
Description
Number of medications to control IOP in the study eye
Time Frame
month 36
Title
Days on Steroid therapy by medical record abstraction
Description
Total number of days of topical steroid therapy postoperatively
Time Frame
week 12
Title
Days on Steroid therapy by medical record abstraction
Description
Total number of days of topical steroid therapy postoperatively
Time Frame
month 6
Title
Days on Steroid therapy by medical record abstraction
Description
Total number of days of topical steroid therapy postoperatively
Time Frame
month 12
Title
Days on Steroid therapy by medical record abstraction
Description
Total number of days of topical steroid therapy postoperatively
Time Frame
month 18
Title
Days on Steroid therapy by medical record abstraction
Description
Total number of days of topical steroid therapy postoperatively
Time Frame
month 24
Title
Days on Steroid therapy by medical record abstraction
Description
Total number of days of topical steroid therapy postoperatively
Time Frame
month 30
Title
Days on Steroid therapy by medical record abstraction
Description
Total number of days of topical steroid therapy postoperatively
Time Frame
month 36
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sarah Jones
Phone
1-919-681-6584
Email
sarah.jones1@duke.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sanjay Asrani, MD
Organizational Affiliation
Duke Eye Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Duke Eye Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sanjay Asrani, MD
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
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