Uveitis, PosteriorPhase 4NCT05322070
Fluocinolone Acetonide Intravitreal Implant 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis
A Phase 4 study testing Fluocinolone Acetonide Intravitreal Implant 0.18 mg in people with Uveitis, Posterior, run by Alimera Sciences at 23 sites in United States.
Trial summary
A study to evaluate the safety and efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Posterior
- What is being tested?
- Fluocinolone Acetonide Intravitreal Implant 0.18 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 125 participants
- Where
- 23 sitesUnited States
- Study dates
- 6 Jun 2022to Nov 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
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
- Male or female in good general health at least 18 years of age at time of consent.
- Presence of active, recurrent, unilateral or bilateral non-infectious uveitis affecting the posterior segment (intraocular inflammation) with a duration of at least 3 months from initial diagnosis, as determined by the Investigator. Intermediate or panuveitis will also be allowed if posterior segment involvement is part of the diagnosis.
- Posterior segment inflammation that has previously demonstrated a clinical response to ≥1 localized corticosteroid treatment (eg, topical steroid 2 to 4 times per day or intra- or peri-ocular injection).
- Presence of macular edema as measured by spectral-domain - optical coherence tomography (SD-OCT) (≥325 microns on Heidelberg SPECTRALIS and ≥315 microns on Zeiss CIRRUS).
- Best corrected visual acuity (BCVA) of the study eye 35-75 letters on the ETDRS chart (Snellen range 20/30 to 20/200).
- Not planning to undergo elective ocular surgery during the study.
- Able to understand, sign the Informed Consent Form (ICF).
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
Who cannot join
- History of macular edema due to diabetes, retinal vein occlusion (RVO), age-related macular degeneration (AMD), or any non-inflammatory cause.
- Intraocular inflammation with infectious etiology.
- Diagnosis of uncontrolled glaucoma or ocular hypertension at Screening, unless study eye is being treated with ≤2 intraocular pressure (IOP)-lowering medications and/or has been previously treated with an incisional surgical procedure OR glaucoma laser procedure resulting in stable IOP in the normal range (10 to 21 mmHg).
- Intraocular pressure >21 mmHg or concurrent therapy at Screening with >2 IOP-lowering pharmacologic agents in the study eye.
- Ocular malignancy in either eye, including choroidal melanoma.
- Previous viral retinitis.
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- Toxoplasmosis scar or scar related to previous viral retinitis in the study eye.
- Ocular and periocular infections such as diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella, mycobacterial infections of the eye, or fungal diseases of ocular structures.
- Hypersensitivity to any of the ingredients contained in YUTIQ®.
- Media opacity precluding evaluation of retina and vitreous (eg, vitreous hemorrhage).
- Any current retinal detachment or retinoschisis in insertion in the study eye.
- Chronic hypotony, defined as <6 mmHg for at least 1 month's duration, and documented on at least two separate visits.
- Ocular surgery within 12 weeks prior to Day 1.
- YAG laser capsulotomy within 30 days prior to Day 1.
- Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 36 months prior to Day 1.
- Prior intravitreal treatment with OZURDEX® within 12 weeks prior to Day 1.
- Prior intravitreal treatment with Triesence® or TRIVARIS™ (triamcinolone) within 12 weeks prior to Day 1.
- Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.
- Radiation to the head or neck within 2 years prior to Screening.
- Steroid allergy, particularly to fluocinolone.
- Any systemic condition that requires chronic systemic anti-inflammatory, steroid, or immunosuppressive therapy (subjects on a stable dose of oral prednisone <7.5 mg per day for a non-ocular indication may be included).
- Positive test for human immunodeficiency virus (HIV), tuberculosis, or syphilis in the past 2 years or during Screening.
- Any severe acute or chronic medical (eg, cancer diagnosis) or psychiatric condition that could increase the risk associated with study participation or could interfere with the interpretation of study results and make the subject inappropriate for study enrollment.
- Any other systemic or ocular condition which, in the judgment of the Investigator, could make the subject inappropriate for study enrollment.
- Treatment with an investigational drug or device within 30 days prior to Day 1.
- Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in the protocol from at least 14 days prior to Day 1 until the final study visit.
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
United States23 sites
Retina Consultants of Texas
Bellaire, Texas, 77401
Opthalmic Consultants of Boston
Boston, Massachusetts, 02114
Midwest Vision Research Foundation at Pepose Vision Institute
Chesterfield, Missouri, 63017
Retinal Vitreal Consultants Ltd.
Chicago, Illinois, 60616
Advanced Research
Coral Springs, Florida, 33067
Erie Retina Research, LLC
Erie, Pennsylvania, 16507
Retina Consultants
Fargo, North Dakota, 58104
Retina Consultants of Orange County
Fullerton, California, 92835
Macula and Retina Institute
Glendale, California, 91203
Foundation for Vision Research
Grand Rapids, Michigan, 49546
Cumberland Valley Retina Consultants
Hagerstown, Maryland, 21740
Retina Consultants of Texas
Katy, Texas, 77494
Retina Associates of Colorado
Lakewood, Colorado, 80228
Marietta Eye Clinic
Marietta, Georgia, 30060
Valley Retina Institute, PA
McAllen, Texas, 78503
Tennessee Retina
Nashville, Tennessee, 37203
Illinois Retina Associates, S.C.
Oak Park, Illinois, 60304
California Eye Specialists Medical Group
Pasadena, California, 91107
Retinal Consultants Medical Group
Sacramento, California, 95825
Medical Center Opthalmology Associates
San Antonio, Texas, 78240
Retina Vitreous Associates
Toledo, Ohio, 43623
Massachusets Eye Research and Surgery Institution
Waltham, Massachusetts, 02451
Retina Specialists of Tampa
Wesley Chapel, Florida, 33544
About this study
Official title: Phase 4 Study of YUTIQ® (Fluocinolone Acetonide Intravitreal Implant) 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis (Intraocular Inflammation Study)
A study to evaluate the safety and efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy.
Read the detailed description
This is a prospective, phase 4, open-label, uncontrolled, 2-year follow-up study to evaluate the safety and efficacy of YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy. Patients will receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye and will be followed for 24 months after treatment.
- Conditions
- Uveitis, Posterior
- Being tested
- Fluocinolone Acetonide Intravitreal Implant 0.18 mg
- Keywords
- Intraocular Inflammation, Fluocinolone Acetonide Intravitreal Implant
- Medical subject headings
- Uveitis, Posterior, Uveitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluocinolone Acetonide Intravitreal Implant 0.18 mgDrug
Also called YUTIQ 0.18 mg
YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye.
| Study group | Role | What they receive |
|---|---|---|
| Fluocinolone Acetonide 0.18 mg | Experimental | Fluocinolone Acetonide Intravitreal Implant 0.18 mg Receives: Drug: Fluocinolone Acetonide Intravitreal Implant 0.18 mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in BCVA
- Mean change from baseline in BCVA letter score in the study eye measured by EDTRS.
Measured: Month 6
Change in CST
- Mean change from baseline central subfield thickness (CST, also known as central foveal thickness) measured by SD-OCT in the study eye.
Measured: Month 6
Secondary outcomes (5)
Recurrence of non-infectious inflammation
- Time to recurrence of non-infectious inflammation in the study eye defined as an increase in CST.
Measured: Months 1, 3, 6, 12, 18, and 24
Presence of vascular leakage
- Presence of vascular leakage as measured by wide field fluorescein angiography.
Measured: Months 1, 3, 6, 12, 18, and 24.
Resolution of macular edema
- Proportion of subjects with resolution of macular edema (central subfield thickness CST) as measured by SD OCT.
Measured: Months 1, 3, 6, 12, 18, and 24
Change in BCVA letter score
- Mean change from baseline in BCVA letter score in the study eye measured by EDTRS.
Measured: Day 14 and at Months 1, 3, 12, 18, and 24
Change from baseline in CST
- Mean change from baseline in CST measured by SD-OCT in the study eye.
Measured: Months 1, 3, 12, 18, and 24
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2022
- Study start6 Jun 2022
- Primary completionNov 2025 (estimated)
- Study completionNov 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uveitis, PosteriorStudies 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
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 125 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alimera Sciences
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Responsible party
- Sponsor
- Investigators
- Antonio Cutino, Study chair, Alimera Sciences Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05322070
- Sponsor's protocol ID
- EYP-YUT-002
- Status last verified
- Aug 2024
- First submitted
- 2 Mar 2022
- Last updated
- 6 Aug 2024
- 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 6 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 4 Study of YUTIQ® (Fluocinolone Acetonide Intravitreal Implant) 0.18 mg in the Treatment of Chronic Non-Infectious Posterior Segment Uveitis (Intraocular Inflammation Study)
- ClinicalTrials.gov ID
- NCT05322070
- Acronym / sponsor ID
- EYP-YUT-002
- Conditions
- Uveitis, Posterior
- Keywords
- Intraocular Inflammation, Fluocinolone Acetonide Intravitreal Implant
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 125 participants (estimated)
- Lead sponsor
- Alimera SciencesIndustry (pharma, biotech, devices)
- Collaborators
- CBCC Global Research
- Study start
- 6 Jun 2022 (actual)
- Primary completion
- Nov 2025 (estimated)
- Study completion
- Nov 2025 (estimated)
- First posted
- 11 Apr 2022 (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.
A study to evaluate the safety and efficacy of YUTIQ® 0.18 mg intravitreal implant for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy.
Detailed description
This is a prospective, phase 4, open-label, uncontrolled, 2-year follow-up study to evaluate the safety and efficacy of YUTIQ® (fluocinolone acetonide intravitreal implant) 0.18 mg for the management of chronic non-infectious posterior segment uveitis (intraocular inflammation) that has responded to previous steroid therapy. Patients will receive YUTIQ® 0.18 mg as an intravitreal injection in the designated study eye and will be followed for 24 months after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Fluocinolone Acetonide 0.18 mg | Experimental | Drug: Fluocinolone Acetonide Intravitreal Implant 0.18 mgFluocinolone Acetonide Intravitreal Implant 0.18 mg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or female in good general health at least 18 years of age at time of consent.
- Presence of active, recurrent, unilateral or bilateral non-infectious uveitis affecting the posterior segment (intraocular inflammation) with a duration of at least 3 months from initial diagnosis, as determined by the Investigator. Intermediate or panuveitis will also be allowed if posterior segment involvement is part of the diagnosis.
- Posterior segment inflammation that has previously demonstrated a clinical response to ≥1 localized corticosteroid treatment (eg, topical steroid 2 to 4 times per day or intra- or peri-ocular injection).
- Presence of macular edema as measured by spectral-domain - optical coherence tomography (SD-OCT) (≥325 microns on Heidelberg SPECTRALIS and ≥315 microns on Zeiss CIRRUS).
- Best corrected visual acuity (BCVA) of the study eye 35-75 letters on the ETDRS chart (Snellen range 20/30 to 20/200).
Key exclusion criteria (26 listed)
- History of macular edema due to diabetes, retinal vein occlusion (RVO), age-related macular degeneration (AMD), or any non-inflammatory cause.
- Intraocular inflammation with infectious etiology.
- Diagnosis of uncontrolled glaucoma or ocular hypertension at Screening, unless study eye is being treated with ≤2 intraocular pressure (IOP)-lowering medications and/or has been previously treated with an incisional surgical procedure OR glaucoma laser procedure resulting in stable IOP in the normal range (10 to 21 mmHg).
- Intraocular pressure >21 mmHg or concurrent therapy at Screening with >2 IOP-lowering pharmacologic agents in the study eye.
- Ocular malignancy in either eye, including choroidal melanoma.
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 |
|---|---|---|
| Fluocinolone Acetonide Intravitreal Implant 0.18 mgAlso: YUTIQ 0.18 mgYUTIQ® 0.18 mg as an intravitreal injection in the designated study eye. | Drug | Fluocinolone Acetonide 0.18 mg |
Primary outcome
Change in BCVA
Time frame: Month 6
• Mean change from baseline in BCVA letter score in the study eye measured by EDTRS.
Change in CST
Time frame: Month 6
• Mean change from baseline central subfield thickness (CST, also known as central foveal thickness) measured by SD-OCT in the study eye.
5 secondary outcomes
Recurrence of non-infectious inflammation
Time frame: Months 1, 3, 6, 12, 18, and 24
Presence of vascular leakage
Time frame: Months 1, 3, 6, 12, 18, and 24.
Resolution of macular edema
Time frame: Months 1, 3, 6, 12, 18, and 24
Change in BCVA letter score
Time frame: Day 14 and at Months 1, 3, 12, 18, and 24
Change from baseline in CST
Time frame: Months 1, 3, 12, 18, and 24
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Aug 2024.
- 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.
Antonio Cutino study chair
Alimera Sciences Inc
23 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Fluocinolone Acetonide Intravitreal Implant 0.18 mg in people with Uveitis, Posterior, run by Alimera Sciences at 23 sites 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 8 inclusion and 26 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: status not confirmed, as of the sponsor's last update on 6 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 sites 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?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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 BCVA (time frame: Month 6). The study lists 2 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 6 Aug 2024.