A Phase 3 interventional study of Sham Injector and FAI Insert in Uveitis, Uveitis, Posterior and Uveitis, Intermediate, sponsored by EyePoint Pharmaceuticals, Inc.. Terminated at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-12-19.
Sponsored by EyePoint Pharmaceuticals, Inc. · Phase 3, Interventional, and Treatment
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.
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.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 12 is below the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →EyePoint Pharmaceuticals, Inc. is the lead sponsor of 19 studies on the registry; none are open to participants now.
Of its 11 completed or terminated interventional studies of FDA-regulated products, 8 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Key Inclusion Criteria:
During the 52 weeks prior to enrollment (Day 1), the subject must have received treatment for uveitis in the study eye with:
Key Exclusion Criteria:
Ocular Exclusion Criteria (for the study eye, unless indicated otherwise):
Peri-ocular or subtenon steroid treatment within 12 weeks prior to Day 1.
All other Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Intravitreal sham injection
Drug: Sham Injector
Fluocinolone acetonide (FA) intravitreal 0.05 mg insert (Yutiq 0.05 mg).
Drug: FAI Insert
Intravitreal sham injection
Also known as: Sham Comparator
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.
Also known as: Active Drug
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.
Time frame: Week 24
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).
Time frame: 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).
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
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.
Time frame: 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).
Time frame: 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).
Time frame: 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.
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
Iridocyclitis was defined as a \>2-step increase in anterior chamber cells per high-power field (HPF) (1.6\*using a 1-millimeter beam).
Time frame: 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.
Time frame: At Day 28 and Months 2, 3, 6 and 12
This Phase 3 prospective, controlled study was conducted in subjects with chronic non-infectious uveitis affecting the posterior segment of the eye at 8 sites in the United States between 13 October 2021 and 12 April 2023.
| Milestone | Fluocinolone Acetonide 0.05 mg | Sham Injection |
|---|---|---|
| Started | 6 | 6 |
| Completed | 6 | 0 |
| Not completed | 0 | 6 |
| Withdrew: Sponsor decided to stop study enrollment and terminate the study | 0 | 6 |
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.
| percentage of subjects | Fluocinolone Acetonide 0.05 mg | Sham Injection |
|---|---|---|
| Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24 | 0 (0 to 45.9) | — |
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).
| percentage of subjects | Fluocinolone Acetonide 0.05 mg | Sham Injection |
|---|---|---|
| Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 52 | 0 (0 to 45.9) | — |
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).
No measurements were reported for this outcome.
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.
| score on a scale | Fluocinolone Acetonide 0.05 mg | Sham Injection |
|---|---|---|
| Week 24 | 9.7 ± 4.93 | — |
| Weeks 52 | 16.8 ± 12.11 | — |
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).
| recurrences of uveitis | Fluocinolone Acetonide 0.05 mg | Sham Injection |
|---|---|---|
| Week 24 | 0 | — |
| Week 52 | 0 | — |
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).
No measurements were reported for this outcome.
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.
No measurements were reported for this outcome.
Iridocyclitis was defined as a \>2-step increase in anterior chamber cells per high-power field (HPF) (1.6\*using a 1-millimeter beam).
No measurements were reported for this outcome.
The macular edema was measured by spectral-domain - optical coherence tomography (SD-OCT) imaging.
| percentage of subjects | Fluocinolone Acetonide 0.05 mg | Sham Injection |
|---|---|---|
| Day 28 - Yes | 50.0 | 60.0 |
| Day 28 - No | 50.0 | 40.0 |
| Month 2 - Yes | 50.0 | 75.0 |
| Month 2 - No | 50.0 | 25.0 |
| Month 3 - Yes | 40.0 | 33.3 |
| Month 3 - No | 60.0 | 66.7 |
| Month 6 - Yes | 20.0 | — |
| Month 6 - No | 80.0 | — |
| Month 12 - Yes | 75.0 | — |
| Month 12 - No | 25.0 | — |
Collected over Treatment-emergent adverse events were collected from the study drug administration (Day 1) up to early termination of the study, approximately 52 weeks.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Fluocinolone Acetonide 0.05 mg - Study Eye | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Fluocinolone Acetonide 0.05 mg - Fellow Eye | 0/6 (0%) | 0/6 (0%) | 4/6 (66.7%) |
| Fluocinolone Acetonide 0.05 mg - Systemic | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Sham Injection- Study Eye | 0/6 (0%) | 1/6 (16.7%) | 2/6 (33.3%) |
| Sham Injection- Fellow Eye | 0/6 (0%) | 0/6 (0%) | 1/6 (16.7%) |
| Sham Injection- Systemic | 0/6 (0%) | 1/6 (16.7%) | 0/6 (0%) |
| Event | Fluocinolone Acetonide 0.05 mg - Study Eye | Fluocinolone Acetonide 0.05 mg - Fellow Eye | Fluocinolone Acetonide 0.05 mg - Systemic | Sham Injection- Study Eye | Sham Injection- Fellow Eye | Sham Injection- Systemic |
|---|---|---|---|---|---|---|
| Visual acuity reducedEye disorders | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 1/6 |
| Event | Fluocinolone Acetonide 0.05 mg - Study Eye | Fluocinolone Acetonide 0.05 mg - Fellow Eye | Fluocinolone Acetonide 0.05 mg - Systemic | Sham Injection- Study Eye | Sham Injection- Fellow Eye | Sham Injection- Systemic |
|---|---|---|---|---|---|---|
| Epiretinal membraneEye disorders | 1/6 | 0/6 | 0/6 | 0/6 | 0/6 | 0/6 |
| Optic atrophyEye disorders | 1/6 | 1/6 | 0/6 | 0/6 | 0/6 | 0/6 |
| Posterior capsule opacificationEye disorders | 1/6 | 1/6 | 0/6 | 0/6 | 0/6 | 0/6 |
| Vision blurredEye disorders | 1/6 | 1/6 | 0/6 | 1/6 | 0/6 | 0/6 |
| Vitreal cellsEye disorders | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 |
| Vitreous hazeEye disorders | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 |
| Intraocular pressure increasedInvestigations | 1/6 | 1/6 | 0/6 | 1/6 | 1/6 | 0/6 |
| Ear infectionInfections and infestations | 0/6 | 0/6 | 1/6 | 0/6 | 0/6 | 0/6 |
| Anterior chamber cellEye disorders | 0/6 | 1/6 | 0/6 | 0/6 | 0/6 | 0/6 |
| Hypotony of eyeEye disorders | 0/6 | 0/6 | 0/6 | 0/6 | 1/6 | 0/6 |
The Intent-To-Treat (ITT) analysis set included all subjects who were randomized.
| Age, Continuous(years) | Fluocinolone Acetonide 0.05 mg | Sham Injection | Total |
|---|---|---|---|
| Mean | 52.3 ± 12.48 | 51.7 ± 19.23 | 52.0 ± 15.46 |
| Sex: Female, Male(Participants) | Fluocinolone Acetonide 0.05 mg | Sham Injection | Total |
|---|---|---|---|
| Female | 3 | 4 | 7 |
| Male | 3 | 2 | 5 |
| Race/Ethnicity, Customized(Participants) | Fluocinolone Acetonide 0.05 mg | Sham Injection | Total |
|---|---|---|---|
| Black or African American | 2 | 1 | 3 |
| White | 3 | 5 | 8 |
| Missing | 1 | 0 | 1 |
| Race/Ethnicity, Customized(Participants) | Fluocinolone Acetonide 0.05 mg | Sham Injection | Total |
|---|---|---|---|
| Hispanic or Latino | 0 | 2 | 2 |
| Not Hispanic or Latino | 3 | 4 | 7 |
| Not Stated | 1 | 0 | 1 |
| Unknown | 2 | 0 | 2 |
PDFs hosted by the registry, ClinicalTrials.gov.
This study is terminated, as verified in Nov 2024. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
EyePoint Pharmaceuticals, Inc.