Non-infectious Intermediate Uveitis, Non-infectious Posterior Uveitis, Non-infectious Panuveitis
Conditions
Keywords
Non-infectious uveitis, Panuveitis, Visual acuity, Vitreous Haze, Inflammation of the uvea, inflammation of the middle, pigmented vascular structures of the eye, iris, ciliary body, choroid plexus
Brief summary
This was a multi-center, randomized, active-controlled, open-label study. Approximately 24 patients with active, non-infectious intermediate-, posterior-, or panuveitis requiring systemic immunosuppressive therapy were enrolled. Safety, efficacy, and PK assessments occurred at scheduled visits over a 12-week period. Low-molecular-weight non-steroidal immunosuppressive medications were allowed up to the baseline day as long as the dose had not changed in the 3 weeks prior to baseline, except for corticosteroid doses for which might have changed. Patients responding to treatment were offered up to 6 months of extended treatment. Assessments for safety included laboratory safety tests, ECGs, physical exams, ocular exams, vital signs and the monitoring of adverse events. Study participation varied from a minimum of 3 months to a maximum of 9 months.
Detailed description
Approximately 24 patients with active non-infectious uveitis, in at least one eye, requiring intensification of systemic immunosuppressive therapy were enrolled and randomized to receive intravitreal LFG316 or conventional therapy (investigator's discretion). Only one eye (the study eye) were treated with LFG316 and the other eye (fellow eye) were treated at the investigator's discretion.Throughout the study, the fellow eye might have been treated as needed; except that certain systemic medications were prohibited. There was 1 screening and 8 scheduled visits over 85 days for a total of 9 site visits for all patients. At Day 85, patients receiving LFG316 treatment who met the criteria for a 'responder', were offered an additional 6 months of LFG316 treatment on a PRN basis. Additional 3 scheduled visits were attended by LFG316-responder patients during the extension period. However, patients could have unscheduled visits as needed and as determined by the investigator. Safety evaluation and ocular assessments were performed throughout the study duration. Patients in the treatment extension phase, who experienced a flare post their last dose and required treatment, might have received a dose of LFG316. These patients were assessed for a response at their next PRN visit as scheduled by the investigator. Visit frequency was determined by the investigator. If they continued to respond to LFG316 therapy, they might have remained in the PRN treatment arm. They might have received up to 7 additional doses of LFG316 in the PRN period. Throughout the trial LFG316 were not administered more frequently than monthly. Patients in the extension phase, who discontinued treatment prematurely were asked to return approximately 1 month after their last dose. Low molecular weight non-steroidal immunosuppressive medications were allowed up to the baseline day as long as the dose had not changed in the 3 weeks prior to baseline, except for corticosteroid doses which might have changed.
Interventions
DRUGLFG316
LFG316 administered intravitreally (IVT)
DRUGConventional Therapy
Conventional Therapy administered in accordance with its prescribing info.
Sponsors
Novartis Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: * Male or female patients 18 years or older * Active NIU, in at least one eye, as defined below, in patients requiring intensification of systemic immunosuppressive therapy; * Vitreous haze at least 1+ on the scale of Nussenblatt et al 1985,or * Chorioretinal lesions due to uveitis (chorioretinal lesions due to infectious uveitis excluded) * Patients with a flare and at the time of the enrollment on systemic corticosteroid or non-steroidal immunosuppressants had their therapy tapered or stopped, respectively, at the time of intravitreal LFG316 administration. Visual acuity (ETDRS method) of 20 letters (20/400 Snellen equivalent) or better in the study eye. * For female patients, must not be pregnant or lactating and must, unless post-menopausal, use effective contraception. * Ability to provide informed consent and comply with the protocol. Key
Exclusion criteria
* Uveitis so severe that, in the investigator's judgment, it was too risky to test an experimental drug * Any biologic immunosuppressive agent given via intravitreal, intravenous or subcutaneous route within 4-12 months depending on the agent. * History of infectious uveitis or endophthalmitis in either eye. * History of retinal detachment * Any intraocular surgery, intravitreal injection, periocular injection, or laser photocoagulation to the study eye within 90 days prior to dosing. * In the study eye, cataract expected to interfere with study conduct or require surgery during the study. * Forms of uveitis that may have spontaneously resolved
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Day 85 (end of study) | Response rate as defined by: 1. An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR 2. An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR 3. An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR 4. Absence of chorioretinal lesions as determined by the investigator |
| Number of Participants With Remission in Study Eye - Treatment Period | Day 85 (end of study) | Remission (complete response) was defined as any patient who had: * a vitreous haze score of 0 or 0.5 (scale of 0 to 4) in the study eye, AND * an anterior chamber cell score of 0 (scale of 0 to 4), AND * no chorioretinal lesions in the study eye, AND * was off all immune modulatory therapy (systemic, corticosteroids and topical), AND * without any worsening of uveitis during the trial. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 85 (end of study) | Macular edema is a sign of uveitis. |
| Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | Chorioretinal lesions is a sign of uveitis. |
| Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | Vitreous haze score (based on funduscopic exam): 0, 0.5/Trace, 1+, 2+, 3+, 4+ Vitreous haze score (scale of 0 to 4) with a score of 4 being the most hazed. |
| Number of Participants With or Without Anti-LFG316 Antibodies | Throughout the study (treatment and extension period), up to day 271 | Blood will be collected at each visit for the profiling of serum drug concentrations. The summary of immunogenicity (IG) by visit . The immunogenicity data (presence/absence of anti-LFG316 antibodies \[anti-drug antibodies\]). NO: No immunogenicity; YES: Positive immunogenicity. |
| Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 2, 15, 29, 43, 57 and, 85 (end of the study) | Percent change from baseline (using each patient's pre-dose value as baseline) in total C5 concentrations. |
| Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | anterior chamber cells score (ACCS) with the scores being 0 (≤ 1 cell), 0.5 (1 to 5 aqueous cells), 1 (6 to 15 aqueous cells), 2 (16 to 25 aqueous cells), 3 (26 to 50 aqueous cells), 4 (\>50 aqueous cells). |
| Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study) | Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions. ETDRS best-corrected visual acuity was obtained in each eye separately under certified ETDRS conditions. This assessment was to be performed prior to pupil dilation. The number of letters read correctly (for each eye) was recorded. BCVA is based on the number of letters read correctly. |
Countries
United Kingdom, United States
Participant flow
Pre-assignment details
Approximately 24 patients were planned to be enrolled. A total of 25 patients were randomized (18 patients in LFG316 group and 7 patients in conventional therapy group).
Participants by arm
| Arm | Count |
|---|---|
| LFG316 LFG316 administered intravitreally | 18 |
| Conventional Therapy Conventional treatment was selected by the investigator | 7 |
| Total | 25 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Treatment Extension Period | Administrative problems | 1 | 0 |
| Treatment Period | Adverse Event | 2 | 0 |
Baseline characteristics
| Characteristic | Conventional Therapy | Total | LFG316 |
|---|---|---|---|
| Age, Continuous | 39.1 Years STANDARD_DEVIATION 14.89 | 43.6 Years STANDARD_DEVIATION 14.81 | 45.3 Years STANDARD_DEVIATION 14.84 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 7 Participants | 23 Participants | 16 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race/Ethnicity, Customized Black | 1 Participants | 2 Participants | 1 Participants |
| Race/Ethnicity, Customized Caucasian | 6 Participants | 23 Participants | 17 Participants |
| Sex: Female, Male Female | 4 Participants | 11 Participants | 7 Participants |
| Sex: Female, Male Male | 3 Participants | 14 Participants | 11 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 18 | 0 / 7 |
| other Total, other adverse events | 11 / 18 | 5 / 7 |
| serious Total, serious adverse events | 1 / 18 | 0 / 7 |
Outcome results
Primary
Number of Participants With Remission in Study Eye - Treatment Period
Remission (complete response) was defined as any patient who had: * a vitreous haze score of 0 or 0.5 (scale of 0 to 4) in the study eye, AND * an anterior chamber cell score of 0 (scale of 0 to 4), AND * no chorioretinal lesions in the study eye, AND * was off all immune modulatory therapy (systemic, corticosteroids and topical), AND * without any worsening of uveitis during the trial.
Time frame: Day 85 (end of study)
Population: Efficacy 1 analysis set
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| LFG316 | Number of Participants With Remission in Study Eye - Treatment Period | 2 Participants |
| Conventional Therapy | Number of Participants With Remission in Study Eye - Treatment Period | 0 Participants |
Primary
Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye
Response rate as defined by: 1. An improvement of 2 or more steps in vitreous haze (scale of 0 to 4), relative to baseline OR 2. An improvement of 10 or more letters in visual acuity (VA), relative to baseline OR 3. An improvement of 2 or more steps in anterior chamber cells (ACC) score (scale of 0 to 4), relative to baseline OR 4. Absence of chorioretinal lesions as determined by the investigator
Time frame: Day 85 (end of study)
Population: Efficacy 1 analysis set: All patients in the safety analysis set who received any study treatment (LFG316 or conventional treatment) with evaluable efficacy data for at least one efficacy endpoint(s) (ocular assessments) and with no major protocol deviations that had an impact on efficacy data.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| LFG316 | Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Improvement of ACC score ≥2 steps (N=7, 1) | 0 Participants |
| LFG316 | Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Improvement of VA ≥ 10 letters (N=15,6) | 0 Participants |
| LFG316 | Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Resolution of chorioretinal lesions (N= 3, 0) | 0 Participants |
| LFG316 | Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Improvement of vitreous haze ≥2 steps (N=15,6) | 3 Participants |
| Conventional Therapy | Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Improvement of VA ≥ 10 letters (N=15,6) | 1 Participants |
| Conventional Therapy | Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Improvement of vitreous haze ≥2 steps (N=15,6) | 3 Participants |
| Conventional Therapy | Number of Participants With Response Rate for the Individual Response Criteria - in the Study Eye | Improvement of ACC score ≥2 steps (N=7, 1) | 0 Participants |
Secondary
Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period
Visual acuity was measured using Early Treatment Diabetic Retinopathy Study (ETDRS) eye charts under ETDRS conditions. ETDRS best-corrected visual acuity was obtained in each eye separately under certified ETDRS conditions. This assessment was to be performed prior to pupil dilation. The number of letters read correctly (for each eye) was recorded. BCVA is based on the number of letters read correctly.
Time frame: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Population: Efficacy 1 analysis set
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LFG316 | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 15 | 68.8 letters | Standard Deviation 18.53 |
| LFG316 | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 43 | 65.5 letters | Standard Deviation 24.45 |
| LFG316 | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 8 | 80.5 letters | Standard Deviation 11.69 |
| LFG316 | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 57 | 72.6 letters | Standard Deviation 14.79 |
| LFG316 | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 29 | 70.3 letters | Standard Deviation 19.39 |
| LFG316 | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 85 | 72.1 letters | Standard Deviation 15.53 |
| LFG316 | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 2 | 72.5 letters | Standard Deviation 19.36 |
| Conventional Therapy | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 85 | 76.7 letters | Standard Deviation 10.25 |
| Conventional Therapy | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 2 | 76.1 letters | Standard Deviation 0.7 |
| Conventional Therapy | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 8 | 79.0 letters | Standard Deviation 79 |
| Conventional Therapy | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 15 | 78.9 letters | Standard Deviation 9.1 |
| Conventional Therapy | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 29 | 79.6 letters | Standard Deviation 9.47 |
| Conventional Therapy | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 43 | 77.3 letters | Standard Deviation 9.07 |
| Conventional Therapy | Mean Best Corrected Visual Acuity (BCVA) in Study Eye - Treatment Period | Day 57 | 80.1 letters | Standard Deviation 10.35 |
Secondary
Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period
Percent change from baseline (using each patient's pre-dose value as baseline) in total C5 concentrations.
Time frame: Day 2, 15, 29, 43, 57 and, 85 (end of the study)
Population: Pharmacodynamic (PD) analysis set: All patients in the safety analysis set with EVALUABLE pharmacodynamics (PD) data (Total C5) and with no major protocol deviations that had an impact on PD data were included in the PD analysis set.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| LFG316 | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 15 | 8.21 Percent change in C5 | Standard Deviation 15.3 |
| LFG316 | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 43 | 8.38 Percent change in C5 | Standard Deviation 13.4 |
| LFG316 | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 2 | 6.80 Percent change in C5 | Standard Deviation 14.5 |
| LFG316 | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 29 | 10.6 Percent change in C5 | Standard Deviation 17.4 |
| LFG316 | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 85 | 3.21 Percent change in C5 | Standard Deviation 22.1 |
| LFG316 | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 57 | 6.73 Percent change in C5 | Standard Deviation 12 |
| Conventional Therapy | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 85 | 1.28 Percent change in C5 | Standard Deviation 31.3 |
| Conventional Therapy | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 2 | 1.02 Percent change in C5 | Standard Deviation 5.69 |
| Conventional Therapy | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 15 | -1.27 Percent change in C5 | Standard Deviation 19.7 |
| Conventional Therapy | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 29 | -8.33 Percent change in C5 | Standard Deviation 17.5 |
| Conventional Therapy | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 43 | 6.46 Percent change in C5 | Standard Deviation 18.6 |
| Conventional Therapy | Mean Percent Change in Total C5 Concentrations in Serum - Treatment Period | Day 57 | 5.98 Percent change in C5 | Standard Deviation 40.9 |
Secondary
Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period
anterior chamber cells score (ACCS) with the scores being 0 (≤ 1 cell), 0.5 (1 to 5 aqueous cells), 1 (6 to 15 aqueous cells), 2 (16 to 25 aqueous cells), 3 (26 to 50 aqueous cells), 4 (\>50 aqueous cells).
Time frame: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Population: Efficacy 1 analysis set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 1; 6-15 cells | 1 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 2; 16-25 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 1; 6-15 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 3; 26-50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 0.5; 1-5 cells | 1 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 4; >50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 2; 16-25 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 0; <1 cell | 5 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 2; 16-25 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 0.5; 1-5 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 3; 26-50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 1; 6-15 cells | 1 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 0; <1 cell | 2 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 2; 16-25 cells | 1 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 4; >50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 3; 26-50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 3; 26-50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 4; >50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 0.5; 1-5 cells | 4 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 0; <1 cell | 5 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 1; 6-15 cells | 1 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 2; 16-25 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 1; 6-15 cells | 2 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 4; >50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 2; 16-25 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 3; 26-50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 3; 26-50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 0.5; 1-5 cells | 4 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 4; >50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 4; >50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 0; <1 cell | 4 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 0; <1 cell | 2 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 0.5; 1-5 cells | 5 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 0; <1 cell | 2 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 1; 6-15 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 0; <1 cell | 3 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 2; 16-25 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 0.5; 1-5 cells | 5 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 3; 26-50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 0.5; 1-5 cells | 4 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 4; >50 cells | 0 Participants |
| LFG316 | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 1; 6-15 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 4; >50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 1; 6-15 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 0; <1 cell | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 0.5; 1-5 cells | 1 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 1; 6-15 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 2; 16-25 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 3; 26-50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 2 | 4; >50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 0; <1 cell | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 0.5; 1-5 cells | 1 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 1; 6-15 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 2; 16-25 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 3; 26-50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 0; <1 cell | 1 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 0.5; 1-5 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 2; 16-25 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 3; 26-50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 15 | 4; >50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 0; <1 cell | 1 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 0.5; 1-5 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 1; 6-15 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 2; 16-25 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 3; 26-50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 29 | 4; >50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 0; <1 cell | 1 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 0.5; 1-5 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 1; 6-15 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 2; 16-25 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 3; 26-50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 43 | 4; >50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 0; <1 cell | 1 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 0.5; 1-5 cells | 1 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 1; 6-15 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 2; 16-25 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 3; 26-50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 57 | 4; >50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 0; <1 cell | 3 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 0.5; 1-5 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 1; 6-15 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 2; 16-25 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 85 | 3; 26-50 cells | 0 Participants |
| Conventional Therapy | Number of Participants With Anterior Chamber Cells Score in Study Eye - Treatment Period | Day 8 | 4; >50 cells | 0 Participants |
Secondary
Number of Participants With or Without Anti-LFG316 Antibodies
Blood will be collected at each visit for the profiling of serum drug concentrations. The summary of immunogenicity (IG) by visit . The immunogenicity data (presence/absence of anti-LFG316 antibodies \[anti-drug antibodies\]). NO: No immunogenicity; YES: Positive immunogenicity.
Time frame: Throughout the study (treatment and extension period), up to day 271
Population: Pharmacokinetic analysis set: All patients in the safety analysis set with evaluable PK data and with no protocol deviations affecting PK data.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | Day 1 | participants with anti-LFG316 antibodies | 3 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | Day 1 | participants without anti-LFG316 antibodies | 12 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | Day 29 | participants with anti-LFG316 antibodies | 3 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | Day 29 | participants without anti-LFG316 antibodies | 10 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | Day 85 (end of study) | participants with anti-LFG316 antibodies | 2 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | Day 85 (end of study) | participants without anti-LFG316 antibodies | 9 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | Day 169 | participants with anti-LFG316 antibodies | 1 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | Day 169 | participants without anti-LFG316 antibodies | 1 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | Day 253 | participants with anti-LFG316 antibodies | 0 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | Day 253 | participants without anti-LFG316 antibodies | 1 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | End of extension period | participants with anti-LFG316 antibodies | 1 Participants |
| LFG316 | Number of Participants With or Without Anti-LFG316 Antibodies | End of extension period | participants without anti-LFG316 antibodies | 0 Participants |
Secondary
Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period
Vitreous haze score (based on funduscopic exam): 0, 0.5/Trace, 1+, 2+, 3+, 4+ Vitreous haze score (scale of 0 to 4) with a score of 4 being the most hazed.
Time frame: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Population: Efficacy 1 analysis set
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 3+ | 1 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 2+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 4+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 3+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 4+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 4+ | 1 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 0.5/Trace | 2 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 0 | 6 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 0 | 2 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 0.5/Trace | 1 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 2+ | 3 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 1+ | 6 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 0 | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 2+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 0.5/Trace | 3 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 3+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 2+ | 1 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 4+ | 1 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 1+ | 6 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 0 | 5 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 0.5/Trace | 1 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 0.5/Trace | 5 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 2+ | 3 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 1+ | 4 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 0 | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 2+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 3+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 3+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 1+ | 4 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 4+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 4+ | 2 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 0 | 2 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 3+ | 2 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 0.5/Trace | 6 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 0 | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 1+ | 3 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 2+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 0.5/Trace | 4 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 3+ | 1 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 1+ | 10 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 4+ | 0 Participants |
| LFG316 | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 1+ | 10 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 0.5/Trace | 3 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 0 | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 0.5/Trace | 1 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 1+ | 4 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 2+ | 1 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 3+ | 1 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 2 | 4+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 0 | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 0.5/Trace | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 1+ | 1 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 2+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 3+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 8 | 4+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 0 | 1 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 0.5/Trace | 1 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 1+ | 4 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 2+ | 1 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 3+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 15 | 4+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 0 | 3 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 0.5/Trace | 1 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 1+ | 3 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 2+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 3+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 29 | 4+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 0 | 2 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 1+ | 1 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 2+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 3+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 43 | 4+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 0 | 2 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 0.5/Trace | 2 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 1+ | 3 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 2+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 3+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 57 | 4+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 0 | 1 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 0.5/Trace | 3 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 1+ | 2 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 2+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 3+ | 0 Participants |
| Conventional Therapy | Number of Participants With Vitreous Haze Score in Study Eye - Treatment Period | Day 85 (end of study) | 4+ | 0 Participants |
Secondary
Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period
Chorioretinal lesions is a sign of uveitis.
Time frame: Day 2, 8, 15, 29, 43, 57 and, 85 (end of the study)
Population: Efficacy 1 analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LFG316 | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 15 | 4 Participants |
| LFG316 | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 43 | 4 Participants |
| LFG316 | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 8 | 2 Participants |
| LFG316 | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 57 | 5 Participants |
| LFG316 | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 29 | 5 Participants |
| LFG316 | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 85 (end of study) | 4 Participants |
| LFG316 | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 2 | 3 Participants |
| Conventional Therapy | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 85 (end of study) | 1 Participants |
| Conventional Therapy | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 2 | 0 Participants |
| Conventional Therapy | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 8 | 0 Participants |
| Conventional Therapy | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 15 | 0 Participants |
| Conventional Therapy | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 29 | 0 Participants |
| Conventional Therapy | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 43 | 0 Participants |
| Conventional Therapy | Number of Patients With Chorioretinal Lesions in Study Eye - Treatment Period | Day 57 | 1 Participants |
Secondary
Number of Patients With Macular Edema in Study Eye - Treatment Period
Macular edema is a sign of uveitis.
Time frame: Day 85 (end of study)
Population: Efficacy 1 analysis set
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| LFG316 | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 57 | 2 Participants |
| LFG316 | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 2 | 2 Participants |
| LFG316 | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 8 | 1 Participants |
| LFG316 | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 15 | 3 Participants |
| LFG316 | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 29 | 2 Participants |
| LFG316 | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 43 | 2 Participants |
| LFG316 | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 85 (end of study) | 2 Participants |
| Conventional Therapy | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 57 | 0 Participants |
| Conventional Therapy | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 29 | 0 Participants |
| Conventional Therapy | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 2 | 1 Participants |
| Conventional Therapy | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 85 (end of study) | 0 Participants |
| Conventional Therapy | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 8 | 1 Participants |
| Conventional Therapy | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 43 | 0 Participants |
| Conventional Therapy | Number of Patients With Macular Edema in Study Eye - Treatment Period | Day 15 | 0 Participants |