Non-Infectious Uveitis
Conditions
Brief summary
This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the Mk II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.
Detailed description
This trial is a 12 month, Phase 3, multi-center, randomized, single-masked (subject), controlled study designed to evaluate the utilization and safety of the MK II inserter and the safety of the FAI insert, in subjects with non-infectious uveitis affecting the posterior segment of the eye.
Interventions
DRUGFAI Insert administered using the Mk II inserter
DRUGFAI Insert administered using the Mk I inserter
Sponsors
EyePoint Pharmaceuticals, Inc.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Male or non-pregnant female at least 18 years of age at time of consent 2. At least one eye has a history of non-infectious uveitis affecting the posterior segment 3. Subject has ability to understand and sign the Informed Consent Form 4. Subject is willing and able to comply with study requirements
Exclusion criteria
1. Allergy to fluocinolone acetonide or any component of the FAI insert 2. Ocular malignancy in either eye, including choroidal melanoma 3. Uveitis with infectious etiology 4. Current viral diseases of the cornea and conjunctiva including epithelial herpes simplex keratitis (dendritic keratitis), vaccinia, and varicella 5. Current mycobacterial infections of the eye or fungal diseases of ocular structures 6. Subjects who yield, during screening, a confirmed positive test for human immune deficiency virus (HIV) or syphilis 7. Systemic infection within 30 days prior to study Day 1 8. Peripheral retinal detachment in area of insertion 9. Elevated intraocular pressure (IOP) \> 21 mmHg, or chronic hypotony \< 6 mmHg 10. Concurrent therapy at screening with IOP-lowering pharmacologic agent in the study eye 11. Current diagnosis of any form of glaucoma or ocular hypertension in study eye at Screening, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmHg) 12. Known history of clinically significant IOP elevation in response to steroid treatment in either eye, unless study eye has been previously treated with an incisional surgery procedure that has resulted in stable IOP in the normal range (10-21 mmHg) 13. Ocular surgery or capsulotomy performed on the study eye within 30 days prior to study Day 1 14. Intravitreal treatment of study eye: with FAI insert within 36 months prior to study Day 1;with Retisert within 30 months prior to study Day 1; with Ozurdex within 90 days prior to study Day 1; or with Triesence or Trivaris within 30 days prior to study Day 1 15. Peri-ocular or subtenon steroid treatment of study eye within 30 days prior to study Day 1 16. Treatment with an investigational drug or device within 30 days prior to study Day 1, except the FAI insert within this protocol 17. Pregnant or nursing females; females of childbearing potential who are unwilling or unable to use an acceptable method of contraception as outlined in this protocol from at least 14 days prior to study Day 1 until the Month 12 Visit 18. Any condition which, in the judgment of the Investigator, could make the subject inappropriate for entry into this study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Day 7 | The primary utilization endpoint was defined as the proportion of intravitreal insertion procedures that were assessed by the investigator as satisfactory. A satisfactory procedure was defined as one receiving a score from the Investigator as either Very Easy, Easy, or Routine. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | Month 12 | To assess the safety of the FAI insert during 12 months following treatment reported as percentages. |
Countries
United States
Participant flow
Recruitment details
One subject was assigned to the Mk II; however, received treatment with the Mk I after attempted to use 2 different Mk II inserters without success and switched to the Mk I inserter. The data for this subject were included in the Mk II inserter treatment group for ITT population and in the Mk I inserter treatment group for the safety population
Pre-assignment details
Prior to analysis no Subjects were Excluded From the Utilization Analysis (i.e., completed Day 7). 1 MKI and 1 MKII eyes were lost to follow-up at Month 12.
Participants by arm
| Arm | Count |
|---|---|
| FAI Insert Administered Using the Mk II Inserter The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana.
FAI Insert administered using the Mk II inserter | 14 |
| FAI Insert Administered Using the Mk II Inserter The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana.
FAI Insert administered using the Mk II inserter | 27 |
| FAI Insert Administered Using the Mk I Inserter The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana.
FAI Insert administered using the Mk I inserter | 12 |
| FAI Insert Administered Using the Mk I Inserter The test article is the Fluocinolone Acetonide Intravitreal (FAI) insert, which contains 0.18 mg FA and delivers FA into the vitreous humor for 36 months, at a nominal rate of approximately 0.2 μg FA/day. The FAI insert will be administered to the study eye as an intravitreal injection through the pars plana.
FAI Insert administered using the Mk I inserter | 11 |
| Total | 64 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Lost to Follow-up | 1 | 1 |
Baseline characteristics
| Characteristic | FAI Insert Administered Using the Mk II Inserter | FAI Insert Administered Using the Mk I Inserter | Total |
|---|---|---|---|
| Age, Continuous | 51.3 Years STANDARD_DEVIATION 11.82 | 48.9 Years STANDARD_DEVIATION 11.19 | 50.4 Years STANDARD_DEVIATION 12.12 |
| Overall Eyes Evaluated | 27 Eyes | 11 Eyes | 38 Eyes |
| Race/Ethnicity, Customized Asian | 1 Eyes | 0 Eyes | 1 Eyes |
| Race/Ethnicity, Customized Black or African American | 5 Eyes | 3 Eyes | 8 Eyes |
| Race/Ethnicity, Customized White | 21 Eyes | 8 Eyes | 29 Eyes |
| Region of Enrollment United States | 27 Eyes | 11 Eyes | 38 Eyes |
| Sex: Female, Male Female | 18 Eyes | 7 Eyes | 25 Eyes |
| Sex: Female, Male Male | 9 Eyes | 4 Eyes | 13 Eyes |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 14 | 0 / 12 |
| other Total, other adverse events | 14 / 14 | 11 / 12 |
| serious Total, serious adverse events | 4 / 14 | 3 / 12 |
Outcome results
Primary
The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment.
The primary utilization endpoint was defined as the proportion of intravitreal insertion procedures that were assessed by the investigator as satisfactory. A satisfactory procedure was defined as one receiving a score from the Investigator as either Very Easy, Easy, or Routine.
Time frame: Day 7
Population: Intent-to-treat population - Assessment Categories
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Mk II Inserter | The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Very Easy | 10 Eyes |
| Mk II Inserter | The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Easy | 3 Eyes |
| Mk II Inserter | The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Routine | 5 Eyes |
| Mk II Inserter | The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Difficult | 7 Eyes |
| Mk II Inserter | The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Very Difficult | 2 Eyes |
| Mk I Inserter | The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Routine | 0 Eyes |
| Mk I Inserter | The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Very Easy | 3 Eyes |
| Mk I Inserter | The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Very Difficult | 2 Eyes |
| Mk I Inserter | The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Easy | 2 Eyes |
| Mk I Inserter | The Utilization of the Mk II Inserter From the Day of Treatment Through 7 Days Following Treatment. | Difficult | 4 Eyes |
Secondary
The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages.
To assess the safety of the FAI insert during 12 months following treatment reported as percentages.
Time frame: Month 12
Population: Overall Summary of Treatment-Emergent Ocular Adverse Events at Month 12 (Safety Population). Note 27/11 (ITT Population) and 26/12 (Safety Population).
| Arm | Measure | Group | Value (COUNT_OF_UNITS) |
|---|---|---|---|
| Mk II Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | Treatment-related TEAE | 10 Eyes |
| Mk II Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | TEAE leading to FAI insert removal | 0 Eyes |
| Mk II Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | Serious TEAE | 1 Eyes |
| Mk II Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | TEAE leading to study discontinuation | 0 Eyes |
| Mk II Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | Treatment-related serious TEAE | 0 Eyes |
| Mk II Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | AE leading to death | 0 Eyes |
| Mk II Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | TEAE | 12 Eyes |
| Mk I Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | AE leading to death | 0 Eyes |
| Mk I Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | TEAE | 7 Eyes |
| Mk I Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | Serious TEAE | 1 Eyes |
| Mk I Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | Treatment-related TEAE | 4 Eyes |
| Mk I Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | Treatment-related serious TEAE | 0 Eyes |
| Mk I Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | TEAE leading to FAI insert removal | 1 Eyes |
| Mk I Inserter | The Safety of the FAI Insert During 12 Months Following Treatment Reported as Percentages. | TEAE leading to study discontinuation | 0 Eyes |