Status:
ACTIVE_NOT_RECRUITING
A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
Lead Sponsor:
Sanjay Asrani
Conditions:
Glaucoma
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
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...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
July 20 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2027
Estimated Enrollment :
5 Patients enrolled
Trial Details
Trial ID
NCT04918121
Start Date
July 20 2021
End Date
June 1 2027
Last Update
November 7 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Duke Eye Center
Durham, North Carolina, United States, 27710