Intermediate Uveitis, Posterior Uveitis
Conditions
Brief summary
This study will evaluate the safety and efficacy of an intravitreal implant of dexamethasone for the treatment of non-infectious intermediate or posterior uveitis.
Interventions
DRUGDexamethasone
Dexamethasone 350 µg; injection drug delivery system at Day 0
DRUGdexamethasone
Dexamethasone 700 µg injection drug delivery system at Day 0
DRUGSham injection
Sham injection at Day 0
Sponsors
Allergan
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years or older with a diagnosis of chronic intermediate uveitis in at least one eye
Exclusion criteria
* Uncontrolled systemic disease * Any active ocular infections
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero | Week 8 | Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe). |
Other
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA) | Week 8 | Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved. |
| Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score | Week 8 | Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality). |
Countries
Australia, Austria, Brazil, Canada, Czechia, France, Germany, Greece, India, Israel, Poland, Portugal, South Africa, South Korea, Spain, Switzerland, United Kingdom, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Dexamethasone 350 µg Dexamethasone 350 µg | 76 |
| Dexamethasone 700 µg Dexamethasone 700 µg | 77 |
| Sham Sham | 76 |
| Total | 229 |
Baseline characteristics
| Characteristic | Dexamethasone 350 µg | Dexamethasone 700 µg | Sham | Total |
|---|---|---|---|---|
| Age, Customized <45 years | 39 Participants | 43 Participants | 41 Participants | 123 Participants |
| Age, Customized >65 years | 5 Participants | 6 Participants | 8 Participants | 19 Participants |
| Age, Customized Between 45 and 65 years | 32 Participants | 28 Participants | 27 Participants | 87 Participants |
| Sex: Female, Male Female | 48 Participants | 46 Participants | 51 Participants | 145 Participants |
| Sex: Female, Male Male | 28 Participants | 31 Participants | 25 Participants | 84 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — | — / — |
| other Total, other adverse events | 58 / 74 | 61 / 76 | 51 / 75 |
| serious Total, serious adverse events | 6 / 74 | 7 / 76 | 5 / 75 |
Outcome results
Primary
Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero
Percentage of patients with Vitreous Haze Score of Zero at Week 8. Score is based on standardized scale of 0 to +4 where 0 equals no inflammation and +4 equals optic nerve head not visible (severe).
Time frame: Week 8
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone 350 µg | Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero | 35.5 Percentage of Patients |
| Dexamethasone 700 µg | Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero | 46.8 Percentage of Patients |
| Sham | Percentage of Patients With Vitreous Haze (Ocular Inflammation) Score of Zero | 11.8 Percentage of Patients |
Other Pre-specified
Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score
Percentage of patients with at least a 10-Point Improvement in the NEI-VFQ-25 over-all composite score at Week 8 from Baseline. The NEI-VFQ-25 consists of 25 vision-targeted questions plus one general health question resulting in a score of 0-100 (100 represents best functionality).
Time frame: Week 8
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone 350 µg | Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score | 40.8 Percentage of Patients |
| Dexamethasone 700 µg | Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score | 50.7 Percentage of Patients |
| Sham | Percentage of Patients With at Least a 10-Point Improvement in the National Eye Institute Visual Functioning Questionnaire-25 (NEI-VFQ-25)Score | 15.9 Percentage of Patients |
Other Pre-specified
Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA)
Percentage of Patients with at least a 15-letter improvement in BCVA at Week 8 from Baseline. BCVA is measured using an eye chart and is reported as the number of letters read correctly (ranging from 0 to 100 letters). The lower the number of letters read correctly on the eye chart, the worse the vision (or visual acuity). The higher the number of letters read correctly, the better the vision (or visual acuity). An improvement in the number of letters read means that the vision has improved.
Time frame: Week 8
Population: Intent to Treat
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Dexamethasone 350 µg | Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA) | 39.5 Percentage of Patients |
| Dexamethasone 700 µg | Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA) | 42.9 Percentage of Patients |
| Sham | Percentage of Patients With at Least a 15-Letter Improvement in Best Corrected Visual Acuity (BCVA) | 6.6 Percentage of Patients |