UveitisPhase 3NCT05070728
Safety and Efficacy of an Injectable Fluocinolone Acetonide Intravitreal (FAI) Insert
A Phase 3 study testing FAI Insert in people with Uveitis and Uveitis, Posterior, run by EyePoint Pharmaceuticals, Inc. at 1 site in United States.
Trial summary
A study to evaluate the safety and efficacy of a fluocinolone acetonide intravitreal (FAI) insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Uveitis, Uveitis, Posterior, Uveitis, Intermediate
- What is being tested?
- FAI Insert
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Oct 2021to 12 Apr 2023
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 non-pregnant female at least 18 years of age at time of consent.
- One or both eyes had a history of recurrent non-infectious uveitis affecting the posterior segment of the eye (intermediate, posterior, or panuveitis) with or without anterior uveitis >1 year duration.
- During the 52 weeks prior to enrollment (Day 1), the subject must have received treatment for uveitis in the study eye with:
- Systemic corticosteroid or other systemic therapies for at least 12 consecutive or non-consecutive weeks, AND/OR
- at least 2 intra- or peri-ocular administrations of corticosteroid in the study eye, OR
- the study eye has experienced recurrence of uveitis at least 2 separate times requiring systemic, intra- or peri-ocular injection of corticosteroid.
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- At the time of enrollment (Day 1), the study eye has <10 anterior chamber cells/HPF (high power field) and a vitreous haze ≤ grade 2.
- Visual acuity of study eye ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
- Not planning to undergo elective ocular surgery during the study.
- Able to understand and 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
- Ocular Exclusion Criteria (for the study eye, unless indicated otherwise):
- History of posterior uveitis only that is not accompanied by vitritis or macular edema.
- History of iritis only associated with no vitreous cells, anterior chamber cells, or vitreous haze at Day 1.
- Uveitis with infectious etiology.
- Vitreous hemorrhage.
- Intraocular inflammation associated with a condition other than noninfectious uveitis (eg, intraocular lymphoma).
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- Uveitis limited to the anterior segment, ie, anterior uveitis only.
- Ocular malignancy in either eye, including choroidal melanoma.
- Previous viral retinitis.
- Toxoplasmosis scar or scar related to previous viral retinitis in the study eye.
- Current viral 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.
- Media opacity precluding evaluation of retina and vitreous.
- Peripheral retinal detachment in area of insertion.
- Diagnosis of any form of glaucoma or ocular hypertension at Screening, unless previously treated with an incisional surgery procedure that has resulted in stable intraocular pressure (IOP) in the normal range [10-21 millimeter of mercury (mmHg)].
- IOP >21 mmHg or concurrent therapy at Screening with any IOP lowering pharmacologic agent.
- Chronic hypotony (<6 mmHg).
- Ocular surgery within 12 weeks prior to Day 1.
- Capsulotomy within 30 days prior to Day 1.
- Prior intravitreal treatment with Retisert®, ILUVIEN®, or YUTIQ® (0.18 mg) within 156 weeks prior to Day 1.
- Prior intravitreal treatment with OZURDEX® or sub-choroidal injection with XIPERE™ within 24 weeks prior to Day 1.
- Prior intravitreal treatment with Triesence® or TRIVARIS™ within 12 weeks prior to Day 1.
- Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.
- All other Exclusion Criteria:
- Allergy to fluocinolone acetonide or any component of Yutiq 0.05 mg.
- Requirement for chronic systemic or inhaled corticosteroid therapy (>15mg prednisone daily) or chronic systemic immunosuppressive therapy.
- History of certain skin cancers (specifically, basal cell carcinoma and squamous cell carcinoma), any malignancy receiving treatment, or in remission less than 5 years prior to Day 1.
- Positive test for human immunodeficiency virus (HIV) or syphilis during Screening.
- Mycobacterial uveitis or chorioretinal changes of either eye which, in the opinion of the Investigator, result from infectious mycobacterial uveitis.
- Systemic infection within 30 days prior to Day 1.
- 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 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 52-week Visit.
- Unlikely to comply with the study protocol or who are likely to be lost to follow-up within 52 weeks.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 3, Multicenter, Prospective, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide (FA) Intravitreal 0.05 mg Insert (Yutiq 0.05 mg) in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
A study to evaluate the safety and efficacy of a fluocinolone acetonide intravitreal (FAI) insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye.
Read the detailed description
This was a phase 3, multicenter, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable FAI insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Subjects were randomized to receive either a sham injection or the FAI insert and were observed for 1 year following treatment.
- Conditions
- Uveitis, Uveitis, Posterior, Uveitis, Intermediate
- Being tested
- Sham Injector, FAI Insert
- Keywords
- EYP-2102, EyePoint, Uveitis
- Medical subject headings
- Uveitis, Uveitis, Posterior, Uveitis, Intermediate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sham InjectorDrug
Also called Sham Comparator
Intravitreal sham injection
FAI InsertDrug
Also called Active Drug
Yutiq 0.05 mg contains 0.05 mg FA and was designed to deliver FA into the vitreous humor for at least 24 weeks.
Yutiq 0.05 mg was administered to the study eye by injection through the pars plana using a pre-loaded applicator with a 25-gauge needle.
| Study group | Role | What they receive |
|---|---|---|
| Sham Comparator | Sham comparator | Intravitreal sham injection Receives: Drug: Sham Injector |
| FAI insert (0.05 mg fluocinolone acetonide) | Active comparator | Fluocinolone acetonide (FA) intravitreal 0.05 mg insert (Yutiq 0.05 mg). Receives: Drug: FAI Insert |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24
Recurrence was defined as:
- An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit; or
- A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit.
Measured: Week 24
Secondary outcomes (8)
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 52
Recurrence was defined as:
- An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or
- A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Measured: Week 52
Percentage of Subjects With Recurrence of Uveitis in the Fellow Eye at Weeks 24 and 52
Recurrence was defined as:
- An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or
- A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Measured: Weeks 24 and 52
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52
The BCVA was measured according to the standard procedure originally developed for Early Treatment Diabetic Retinopathy Study (ETDRS). The ETDRS letter score calculated when 20 or more letters were read correctly at 4.0 meters; the visual acuity letter score was equal to the total number of letters read correctly at 4.0 meters plus 30. The score ranges from 0 (worse) to 100 (best). Higher scores indicate positive outcome measure.
Measured: Weeks 24 and 52
Number of Recurrences of Uveitis Within 24 and 52 Weeks
Recurrence was defined as:
An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Measured: Weeks 24 and 52
Time to Recurrence of Uveitis Through Weeks 24 and 52
Recurrence was defined as:
An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
Measured: Weeks 24 and 52
Number of Adjunctive Treatments Required to Treat Recurrences of Uveitis at 24 and 52 Weeks
Recurrence was defined as:
An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit); or A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit (or the Week 52 visit).
In the event of a uveitis recurrence in either eye, peri-ocular or intraocular corticosteroid injections, or topical medications administered as first line local therapy.
Measured: Weeks 24 and 52
Percentage of Subjects With Recurrence of Iridocyclitis in the Study Eye Compared to Baseline at 24 and 52 Weeks
Iridocyclitis was defined as a >2-step increase in anterior chamber cells per high-power field (HPF) (1.6*using a 1-millimeter beam).
Measured: Weeks 24 and 52
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
The macular edema was measured by spectral-domain - optical coherence tomography (SD-OCT) imaging.
Measured: At Day 28 and Months 2, 3, 6 and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2021
- Study start13 Oct 2021
- Primary completion12 Apr 2023
- Study completion12 Apr 2023
Why it stopped: No longer pursuing indication
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for UveitisStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 12 participants (actual)
Sponsor and investigators
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05070728
- Sponsor's protocol ID
- EYP-2102-001
- Status last verified
- Nov 2024
- First submitted
- 27 Sep 2021
- Last updated
- 19 Dec 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Multicenter, Prospective, Randomized, Masked, Controlled, Safety and Efficacy Study of a Fluocinolone Acetonide (FA) Intravitreal 0.05 mg Insert (Yutiq 0.05 mg) in Subjects With Chronic Non-Infectious Uveitis Affecting the Posterior Segment of the Eye
- ClinicalTrials.gov ID
- NCT05070728
- Acronym / sponsor ID
- EYP-2102-001
- Conditions
- Uveitis, Uveitis, Posterior, Uveitis, Intermediate
- Keywords
- EYP-2102, EyePoint, Uveitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: No longer pursuing indication
- Enrolment
- 12 participants (actual)
- Lead sponsor
- EyePoint Pharmaceuticals, Inc.Industry (pharma, biotech, devices)
- Study start
- 13 Oct 2021 (actual)
- Primary completion
- 12 Apr 2023 (actual)
- Study completion
- 12 Apr 2023 (actual)
- First posted
- 7 Oct 2021 (actual)
- Results
- Posted 19 Dec 2024
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 a fluocinolone acetonide intravitreal (FAI) insert in the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye.
Detailed description
This was a phase 3, multicenter, randomized, masked, controlled study to evaluate the safety and efficacy of an injectable FAI insert for the management of subjects with chronic non-infectious uveitis affecting the posterior segment of the eye. Subjects were randomized to receive either a sham injection or the FAI insert and were observed for 1 year following treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Sham Comparator | Sham comparator | Drug: Sham InjectorIntravitreal sham injection |
| FAI insert (0.05 mg fluocinolone acetonide) | Active comparator | Drug: FAI InsertFluocinolone acetonide (FA) intravitreal 0.05 mg insert (Yutiq 0.05 mg). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Male or non-pregnant female at least 18 years of age at time of consent.
- One or both eyes had a history of recurrent non-infectious uveitis affecting the posterior segment of the eye (intermediate, posterior, or panuveitis) with or without anterior uveitis >1 year duration.
- During the 52 weeks prior to enrollment (Day 1), the subject must have received treatment for uveitis in the study eye with:
- At the time of enrollment (Day 1), the study eye has <10 anterior chamber cells/HPF (high power field) and a vitreous haze ≤ grade 2.
- Visual acuity of study eye ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart.
Key exclusion criteria (34 listed)
- History of posterior uveitis only that is not accompanied by vitritis or macular edema.
- History of iritis only associated with no vitreous cells, anterior chamber cells, or vitreous haze at Day 1.
- Uveitis with infectious etiology.
- Vitreous hemorrhage.
- Intraocular inflammation associated with a condition other than noninfectious uveitis (eg, intraocular lymphoma).
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 |
|---|---|---|
| Sham InjectorAlso: Sham ComparatorIntravitreal sham injection | Drug | Sham Comparator |
| FAI InsertAlso: Active DrugYutiq 0.05 mg contains 0.05 mg FA and was designed to deliver FA into the vitreous humor for at least 24 weeks. Yutiq 0.05 mg was administered to the study eye by injection through the pars plana using a pre-loaded applicator with a 25-gauge needle. | Drug | FAI insert (0.05 mg fluocinolone acetonide) |
Primary outcome
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24
Time frame: Week 24
Recurrence was defined as: * An increase in the vitreous haze of ≥2 steps compared to baseline or any visit time point prior to the Week 24 visit; or * A deterioration in visual acuity of at least 15 letters BCVA compared to baseline or any visit time point prior to the Week 24 visit.
8 secondary outcomes
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 52
Time frame: Week 52
Percentage of Subjects With Recurrence of Uveitis in the Fellow Eye at Weeks 24 and 52
Time frame: Weeks 24 and 52
Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52
Time frame: Weeks 24 and 52
Number of Recurrences of Uveitis Within 24 and 52 Weeks
Time frame: Weeks 24 and 52
Time to Recurrence of Uveitis Through Weeks 24 and 52
Time frame: Weeks 24 and 52
Number of Adjunctive Treatments Required to Treat Recurrences of Uveitis at 24 and 52 Weeks
Time frame: Weeks 24 and 52
Percentage of Subjects With Recurrence of Iridocyclitis in the Study Eye Compared to Baseline at 24 and 52 Weeks
Time frame: Weeks 24 and 52
Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12
Time frame: At Day 28 and Months 2, 3, 6 and 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Dec 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing FAI Insert in people with Uveitis and Uveitis, Posterior, run by EyePoint Pharmaceuticals, Inc. 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 11 inclusion and 34 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: stopped early, as of the sponsor's last update on 19 Dec 2024. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 19 Dec 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24 (time frame: Week 24). 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 19 Dec 2024.