Clinical trial NCT04918121: 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
Overall status: ACTIVE_NOT_RECRUITING
Phase: EARLY_PHASE1
Conditions: Glaucoma
Lead sponsor: Duke University
Sponsor class: OTHER
First posted: 2021-06-08
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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).

Primary outcomes:
measure: Change in IOP measured using Goldman applanation tonometry
timeFrame: week 12, month 6, month 12, month 18, month 24, month 30 , month 36
measure: Change in IOP measured using tonopen/Icare
timeFrame: week 12, month 6, month 12, month 18, month 24, month 30 , month 36
measure: Medications usage as measured by medical record abstraction
timeFrame: week 12
measure: Medications usage by medical record abstraction
timeFrame: month 6
measure: Medications usage by medical record abstraction
timeFrame: month 12
measure: Medications usage by medical record abstraction
timeFrame: month 18
measure: Medications usage by medical record abstraction
timeFrame: month 24
measure: Medications usage by medical record abstraction
timeFrame: month 30
measure: Medications usage by medical record abstraction
timeFrame: month 36
measure: Days on Steroid therapy by medical record abstraction
timeFrame: week 12
measure: Days on Steroid therapy by medical record abstraction
timeFrame: month 6
measure: Days on Steroid therapy by medical record abstraction
timeFrame: month 12
measure: Days on Steroid therapy by medical record abstraction
timeFrame: month 18
measure: Days on Steroid therapy by medical record abstraction
timeFrame: month 24
measure: Days on Steroid therapy by medical record abstraction
timeFrame: month 30
measure: Days on Steroid therapy by medical record abstraction
timeFrame: month 36
Secondary outcomes:
Other outcomes:
Locations:
city: Durham
country: United States
facility: Duke Eye Center
state: North Carolina
Study officials:
affiliation: Duke Eye Center
name: Sanjay Asrani, MD
role: PRINCIPAL_INVESTIGATOR
References: