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出境医 / 临床实验 / A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery

A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery

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.

Condition or disease Intervention/treatment Phase
Glaucoma Drug: Yutiq 0.18 MG Drug Implant Early Phase 1

Study Design
Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 5 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
Actual Study Start Date : July 20, 2021
Estimated Primary Completion Date : December 2024
Estimated Study Completion Date : December 2024
Arms and Interventions
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
Outcome Measures
Primary Outcome Measures :
  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


Eligibility Criteria
Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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).
Contacts and Locations

Contacts
Layout table for location contacts
Contact: Sarah Jones 1-919-681-6584 sarah.jones1@duke.edu

Locations
Layout table for location information
United States, North Carolina
Duke Eye Center Recruiting
Durham, North Carolina, United States, 27710
Contact: Sanjay Asrani, MD         
Sponsors and Collaborators
Sanjay Asrani
Investigators
Layout table for investigator information
Principal Investigator: Sanjay Asrani, MD Duke Eye Center
Tracking Information
First Submitted Date  ICMJE June 2, 2021
First Posted Date  ICMJE June 8, 2021
Last Update Posted Date August 27, 2021
Actual Study Start Date  ICMJE July 20, 2021
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 2, 2021)
  • 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
  • Medications usage by medical record abstraction [ Time Frame: month 24 ]
    Number of medications to control IOP in the study eye
  • Medications usage by medical record abstraction [ Time Frame: month 30 ]
    Number of medications to control IOP in the study eye
  • Medications usage by medical record abstraction [ Time Frame: month 36 ]
    Number of medications to control IOP in the study eye
  • Days on Steroid therapy by medical record abstraction [ Time Frame: week 12 ]
    Total number of days of topical steroid therapy postoperatively
  • Days on Steroid therapy by medical record abstraction [ Time Frame: month 6 ]
    Total number of days of topical steroid therapy postoperatively
  • Days on Steroid therapy by medical record abstraction [ Time Frame: month 12 ]
    Total number of days of topical steroid therapy postoperatively
  • Days on Steroid therapy by medical record abstraction [ Time Frame: month 18 ]
    Total number of days of topical steroid therapy postoperatively
  • Days on Steroid therapy by medical record abstraction [ Time Frame: month 24 ]
    Total number of days of topical steroid therapy postoperatively
  • Days on Steroid therapy by medical record abstraction [ Time Frame: month 30 ]
    Total number of days of topical steroid therapy postoperatively
  • Days on Steroid therapy by medical record abstraction [ Time Frame: month 36 ]
    Total number of days of topical steroid therapy postoperatively
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
Official Title  ICMJE A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Early Phase 1
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Glaucoma
Intervention  ICMJE Drug: Yutiq 0.18 MG Drug Implant
a sustained-release steroid insert (Yutiq)
Study Arms  ICMJE
  • 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.
    Intervention: Drug: Yutiq 0.18 MG Drug Implant
  • No Intervention: Control
    Non-study eye will not receive the Yutiq insert
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: June 2, 2021) 		5
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2024
Estimated Primary Completion Date December 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sarah Jones 1-919-681-6584 sarah.jones1@duke.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04918121
Other Study ID Numbers  ICMJE Pro00106901
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Sanjay Asrani, Duke University
Study Sponsor  ICMJE Sanjay Asrani
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Sanjay Asrani, MD Duke Eye Center
PRS Account Duke University
Verification Date August 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP