Uveitis, Uveitis, Intermediate, Uveitis, Posterior
Conditions
Keywords
EYP-2102, EyePoint, Uveitis
Brief 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.
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.
Interventions
DRUGSham Injector
Intravitreal sham injection
DRUGFAI Insert
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.
Sponsors
EyePoint Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Male or non-pregnant female at least 18 years of age at time of consent. 2. 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. 3. During the 52 weeks prior to enrollment (Day 1), the subject must have received treatment for uveitis in the study eye with: 1. Systemic corticosteroid or other systemic therapies for at least 12 consecutive or non-consecutive weeks, AND/OR 2. at least 2 intra- or peri-ocular administrations of corticosteroid in the study eye, OR 3. the study eye has experienced recurrence of uveitis at least 2 separate times requiring systemic, intra- or peri-ocular injection of corticosteroid. 4. 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. 5. Visual acuity of study eye ≥15 letters on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart. 6. Not planning to undergo elective ocular surgery during the study. 7. Able to understand and sign the Informed Consent Form (ICF). 8. Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures. Key
Exclusion criteria
Ocular
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24 | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Subjects With Recurrence of Uveitis in the Fellow Eye at Weeks 24 and 52 | 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). |
| Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52 | 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. |
| Number of Recurrences of Uveitis Within 24 and 52 Weeks | 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). |
| Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 52 | 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). |
| Number of Adjunctive Treatments Required to Treat Recurrences of Uveitis at 24 and 52 Weeks | 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). 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. |
| Percentage of Subjects With Recurrence of Iridocyclitis in the Study Eye Compared to Baseline at 24 and 52 Weeks | Weeks 24 and 52 | Iridocyclitis was defined as a \>2-step increase in anterior chamber cells per high-power field (HPF) (1.6\*using a 1-millimeter beam). |
| Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | 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 to Recurrence of Uveitis Through Weeks 24 and 52 | 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). |
Countries
United States
Participant flow
Recruitment details
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.
Pre-assignment details
This study consists of a screening period (up to 30 days) and treatment period (52 weeks). A total of 12 subjects were enrolled in the study.
Participants by arm
| Arm | Count |
|---|---|
| Fluocinolone Acetonide 0.05 mg Subjects received a single dose of intravitreal fluocinolone acetonide 0.05 mg on Day 1. | 6 |
| Sham Injection Subjects received a single intravitreal sham injection on Day 1. | 6 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Sponsor decided to stop study enrollment and terminate the study | 0 | 6 |
Baseline characteristics
| Characteristic | Fluocinolone Acetonide 0.05 mg | Sham Injection | Total |
|---|---|---|---|
| Age, Continuous | 52.3 years STANDARD_DEVIATION 12.48 | 51.7 years STANDARD_DEVIATION 19.23 | 52.0 years STANDARD_DEVIATION 15.46 |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 1 Participants | 3 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 3 Participants | 4 Participants | 7 Participants |
| Race/Ethnicity, Customized Not Stated | 1 Participants | 0 Participants | 1 Participants |
| Race/Ethnicity, Customized Unknown | 2 Participants | 0 Participants | 2 Participants |
| Race/Ethnicity, Customized White | 3 Participants | 5 Participants | 8 Participants |
| Sex: Female, Male Female | 3 Participants | 4 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk | EG004 affected / at risk | EG005 affected / at risk |
|---|---|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 | 0 / 6 |
| other Total, other adverse events | 4 / 6 | 4 / 6 | 1 / 6 | 2 / 6 | 1 / 6 | 0 / 6 |
| serious Total, serious adverse events | 0 / 6 | 0 / 6 | 0 / 6 | 1 / 6 | 0 / 6 | 1 / 6 |
Outcome results
Primary
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
Population: The ITT analysis set included all subjects who were randomized. Data was not collected for Sham injection group due to early termination of study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 24 | 0 percentage of subjects |
Secondary
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
Population: The ITT analysis set included all subjects who were randomized. Data was not collected for Sham injection group due to early termination of study.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Fluocinolone Acetonide 0.05 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52 | Week 24 | 9.7 score on a scale | Standard Deviation 4.93 |
| Fluocinolone Acetonide 0.05 mg | Mean Change From Baseline in Best Corrected Visual Acuity (BCVA) Letter Score in the Study Eye at Weeks 24 and 52 | Weeks 52 | 16.8 score on a scale | Standard Deviation 12.11 |
Secondary
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
Population: The ITT analysis set included all subjects who were randomized. Only subjects with recurrence of uveitis are reported. Data was not collected for Sham injection group due to early termination of study.
Secondary
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
Population: The ITT analysis set included all subjects who were randomized. Data was not collected for Sham injection group due to early termination of study.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluocinolone Acetonide 0.05 mg | Number of Recurrences of Uveitis Within 24 and 52 Weeks | Week 24 | 0 recurrences of uveitis |
| Fluocinolone Acetonide 0.05 mg | Number of Recurrences of Uveitis Within 24 and 52 Weeks | Week 52 | 0 recurrences of uveitis |
Secondary
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
Population: Data was not collected for this outcome measure due to early termination of study.
Secondary
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
Population: Data was not collected for this outcome measure due to early termination of study.
Secondary
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
Population: The ITT analysis set included all subjects who were randomized. Data was not collected for Sham injection group due to early termination of study.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Recurrence of Uveitis in the Study Eye at Week 52 | 0 percentage of subjects |
Secondary
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
Population: The ITT analysis set included all subjects who were randomized. Only subjects analyzed at specific timepoints are reported.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 6 - No | 80.0 percentage of subjects |
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 3 - Yes | 40.0 percentage of subjects |
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 3 - No | 60.0 percentage of subjects |
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 12 - Yes | 75.0 percentage of subjects |
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 12 - No | 25.0 percentage of subjects |
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 6 - Yes | 20.0 percentage of subjects |
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Day 28 - Yes | 50.0 percentage of subjects |
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Day 28 - No | 50.0 percentage of subjects |
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 2 - Yes | 50.0 percentage of subjects |
| Fluocinolone Acetonide 0.05 mg | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 2 - No | 50.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Day 28 - Yes | 60.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 2 - No | 25.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Day 28 - No | 40.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 3 - No | 66.7 percentage of subjects |
| Sham Injection | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 2 - Yes | 75.0 percentage of subjects |
| Sham Injection | Percentage of Subjects With Resolution of Macular Edema at Day 28 and Months 2, 3, 6 and 12 | Month 3 - Yes | 33.3 percentage of subjects |
Secondary
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
Population: The ITT analysis set included all subjects who were randomized. Only subjects with recurrence of uveitis are reported. Data was not collected for Sham injection group due to early termination of study.