GlaucomaEarly Phase 1NCT04918121
A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
A Early Phase 1 study testing Yutiq 0.18 MG Drug Implant in people with Glaucoma, run by Sanjay Asrani at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Glaucoma
- What is being tested?
- Yutiq 0.18 MG Drug Implant
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 5 participants
- Where
- 1 siteUnited States
- Study dates
- 20 Jul 2021to Jun 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
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- 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).
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Glaucoma
- Being tested
- Yutiq 0.18 MG Drug Implant
- Medical subject headings
- Glaucoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yutiq 0.18 MG Drug ImplantDrug
a sustained-release steroid insert (Yutiq)
| Study group | Role | What they receive |
|---|---|---|
| Yutiq | Experimental | 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. Receives: Drug: Yutiq 0.18 MG Drug Implant |
| Control | No intervention | Non-study eye will not receive the Yutiq insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in IOP measured using Goldman applanation tonometry
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert
Measured: week 12, month 6, month 12, month 18, month 24, month 30 , month 36
Change in IOP measured using tonopen/Icare
IOP in study eyes compared to eyes undergoing the same surgery without the Yutiq insert
Measured: week 12, month 6, month 12, month 18, month 24, month 30 , month 36
Medications usage as measured by medical record abstraction
Number of medications to control IOP in the study eye
Measured: week 12
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Measured: month 6
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Measured: month 12
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Measured: month 18
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Measured: month 24
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Measured: month 30
Medications usage by medical record abstraction
Number of medications to control IOP in the study eye
Measured: month 36
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Measured: week 12
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Measured: month 6
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Measured: month 12
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Measured: month 18
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Measured: month 24
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Measured: month 30
Days on Steroid therapy by medical record abstraction
Total number of days of topical steroid therapy postoperatively
Measured: month 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jun 2021
- Study start20 Jul 2021
- Primary completionJun 2027 (estimated)
- Study completionJun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GlaucomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 5 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanjay Asrani
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Sanjay Asrani, Duke University
- Investigators
- Sanjay Asrani, MD, Principal investigator, Duke Eye Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04918121
- Sponsor's protocol ID
- Pro00106901
- Status last verified
- Nov 2025
- First submitted
- 2 Jun 2021
- Last updated
- 10 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of Yutiq Steroid Insert During Glaucoma Tube Implant Surgery
- ClinicalTrials.gov ID
- NCT04918121
- Acronym / sponsor ID
- Pro00106901
- Conditions
- Glaucoma
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 5 participants (estimated)
- Lead sponsor
- Sanjay AsraniUniversity, hospital or other
- Study start
- 20 Jul 2021 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jun 2027 (estimated)
- First posted
- 8 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Yutiq | Experimental | Drug: Yutiq 0.18 MG Drug ImplantA 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. |
| Control | No intervention | –Non-study eye will not receive the Yutiq insert |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (15 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yutiq 0.18 MG Drug Implanta sustained-release steroid insert (Yutiq) | Drug | Yutiq |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Nov 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sanjay Asrani, MD principal investigator
Duke Eye Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Yutiq 0.18 MG Drug Implant in people with Glaucoma, run by Sanjay Asrani at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 10 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in IOP measured using Goldman applanation tonometry (time frame: week 12, month 6, month 12, month 18, month 24, month 30 , month 36). The study lists 16 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Nov 2025.