Uveitis
Conditions
Keywords
Panuveitis, Intermediate Uveitis, Uveitis
Brief summary
Background: Uveitis is an inflammation of the eye that can cause vision loss. It is treated with medications and sometimes surgery. However, in many people, treatment does not always prevent loss of vision. A new medication, ustekinumab, reduces inflammation in patients with other inflammatory diseases. Therefore, it might be helpful in treatment of uveitis. Objective: To see if ustekinumab is safe and can help people with uveitis. Eligibility: People ages 18 and older with uveitis Design: Participants will be screened with: Medical and eye disease history Physical exam Eye exam: The pupil is dilated with eye drops. A machine scans the back of the eye. Pictures are taken of the inside of the eye. Blood and urine tests Tuberculosis test Participants will have 6 clinic visits over 28 weeks. Visits lasts 2-3 hours and include: * Medical and eye disease history * Physical and eye exams * Blood and urine tests * Fluorescein angiography: A needle guides a thin plastic tube into an arm vein. A dye is injected into the tube. The dye travels through the veins up to the blood vessels in the eyes. A camera takes pictures of the dye as it flows through the blood vessels in the eyes. * Cohort 1 - Ustekinumab injections at Weeks 0, 4, and 8: The injection is under the skin of the upper arm, leg, or abdomen. Participants will have their uveitis monitored and receive standard uveitis care during the study. * Cohort 2 - Ustekinumab injections via intravenous (IV) injection at first visit, followed by a single 90 mg injection of ustekinumab under the skin of the upper arm, leg or abdomen. For the IV injection a needle will be used to guide a thin plastic tube (catheter) into one of the arm veins. The needle will be removed, leaving only the catheter in the vein.
Detailed description
Objective: Uveitis refers to intraocular inflammatory diseases that are an important cause of visual loss. Standard systemic immunosuppressive medications for uveitis can cause significant adverse effects and many patients continue to experience disease flare-ups. Ustekinumab is a human IL-12 and -23 antagonist. The involvement of IL-12 and IL-23 in the pathophysiology of uveitis and other autoimmune diseases known to be associated with uveitis suggests that ustekinumab could be a potential treatment for uveitis. The study objective is to investigate the safety, tolerability and potential efficacy of ustekinumab as a possible treatment for active intermediate uveitis, posterior uveitis or panuveitis. Study Population: The first cohort will consist of five participants with active intermediate uveitis, posterior uveitis or panuveitis who meet the inclusion criteria. The second cohort will include up to four participants with active intermediate uveitis, posterior uveitis or panuveitis who meet the inclusion criteria. Up to eleven participants may be enrolled, as up to two participants may be accrued in the second cohort to account for participants who withdraw from the study prior to Week 16. Design: This is a prospective, non-randomized, uncontrolled, two-arm pilot study to evaluate of ustekinumab as a possible treatment for active intermediate uveitis, posterior uveitis or panuveitis. Five participants in the first cohort will receive a 90 mg subcutaneous (SC) injection of ustekinumab at baseline and a second and third injection at Week 4 and 8 for a total of 3 injections. For the second cohort, up to four participants will receive an initial high, weight-based dose of ustekinumab via intravenous (IV) injection (up to 55 kg, 260 mg (2 vials); greater than 55 kg to 85 kg, 390 mg (3 vials); greater than 85 kg, 520 mg (4 vials)), followed by a single 90 mg subcutaneous injection at Week 8. In participants who demonstrate allergic reaction to the first dose, the second dose can also be administered as IV infusion with pre-infusion desensitization instead of a subcutaneous injection as it allows better control on the rate of drug administration. Participants will continue in the study for a total of 28 weeks and will be able to receive standard of care after the first 16 weeks. Outcome Measures: For each cohort, the primary outcome is the number of participants who experience treatment response by Week 16. Secondary outcomes for each cohort include changes in visual acuity, the number of participants who experience a recurrence, the number of days to recurrence, presence or extent of macular edema, the amount of retino-vascular leakage, changes in retinal thickening, the length of time to quiescence and the ability to taper concomitant immunosuppressive medications. Safety outcomes for each cohort include the number and severity of systemic and ocular toxicities and adverse events, the proportion of participants who experience vision loss of greater than or equal to 15 letters as measured by Electronic Visual Acuity (EVA) and the number of participants who experience a substantial rise in elevated intraocular pressure (IOP).
Interventions
DRUGUstekinumab
Subcutaneous Injection
Sponsors
National Eye Institute (NEI)
Study design
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
-INCLUSION CRITERIA: 1. Participant has the ability to understand and sign the informed consent document. 2. Participant is 18 years of age or older. 3. Participant has negative purified protein derivative (PPD) or quantiferon testing done within three months prior to enrollment or had latent tuberculosis (TB) but has completed prophylactic anti-TB treatment. 4. Participant has active intermediate uveitis, posterior uveitis or panuveitis in at least one eye requiring systemic therapy. Active disease is defined as: * +1 or more vitreous haze (according to Standardization of Uveitis Nomenclature (SUN) criteria) AND/OR * Active chorioretinitis or leakage on Fluorescein angiography (FA)(that is in more than one quadrant) that requires treatment. 5. Participant has visual acuity in at least one eye of 20/400 or better. 6. Participant is willing and able to comply with the study procedures. 7. Female participants of childbearing potential must not be pregnant or breast-feeding, have a negative pregnancy test at screening and must be willing to undergo pregnancy testing throughout the study. 8. Both female participants of childbearing potential and male participants able to father a child must have (or have a partner who has) had a hysterectomy or vasectomy, be completely abstinent from intercourse or must agree to practice two effective methods of contraception throughout the course of the study and for six weeks after the last investigational product injection. Acceptable methods of contraception for this study include: * hormonal contraception (i.e., birth control pills, injected hormones, dermal patch or vaginal ring), * intrauterine device, * barrier methods (diaphragm, condom) with spermicide, or * surgical sterilization (tubal ligation).
Exclusion criteria
1. Participant has a significant active infection (an infection requiring treatment as determined by the medical team), including active tuberculosis or human immunodeficiency virus (HIV). 2. Participant received a live vaccination within the past six weeks. 3. Participant is expected to receive a live vaccination at any time during the study. 4. Participant received the Bacillus Calmette-Guerin (BCG) vaccine within the past year. 5. Participant is expected to receive the BCG vaccine at any time during the study or up to one year after discontinuing ustekinumab. 6. Participant has a history of cancer (other than a non-melanoma skin cancer) diagnosed within the past five years. 7. Participant has received intraocular (or periocular) steroid or anti-vascular endothelial growth factor (VEGF) injections within the last six weeks. 8. Participant received rituximab within the last six months or another biologic agent (e.g., infliximab, daclizumab, adalimumab) within the last two months. 9. Participant has received alkylating agents (e.g., cyclophosphamide, chlorambucil) within the last nine months. 10. Participant has a known hypersensitivity to ustekinumab or any of its components.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Experiencing a Treatment Response by Week 16 | Baseline to Week 16 | The primary outcome is the number of participants in each cohort who experience a treatment response by Week 16. Treatment response is defined as experiencing all of the following for both/eligible eyes: no active inflammatory chorioretinal lesion and/or absent or decreased retinal vascular leakage; ≤ 0.5+ anterior chamber (AC) cells; ≤ 0.5+ vitreous haze. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 4, Week 8, Week 12, Week 16, Week 28 | Presence or extent of macular edema as determined by optical coherence tomography (OCT) in the left eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28). The number of participants that did and did not have macular edema present is presented. |
| Length of Time to Quiescence in the Right Eye | Baseline to Week 16 | Mean length of time to first experience of quiescence in the right eye. Quiescence refers to absence of active disease defined as not having the following conditions: +1 or more vitreous haze; and/or active chorioretinitis or leakage on fluorescein angiogram (FA) (that is more than one quadrant) that requires treatment. |
| Length of Time to Quiescence in the Left Eye | Baseline to Week 16 | Mean length of time to first experience of quiescence in the left eye. Quiescence refers to absence of active disease defined as not having the following conditions: +1 or more vitreous haze; and/or active chorioretinitis or leakage on fluorescein angiogram (FA) (that is more than one quadrant) that requires treatment. |
| Ability to Taper Concomitant Immunosuppressive Medications | Baseline to Week 28 | The number of participants able to taper concomitant immunosuppressive medications. |
| Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Baseline to Week 4, Week 8, Week 12, Week 16, Week 28 | Mean change in visual acuity in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline as measured by electronic visual acuity (EVA). |
| Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Baseline to Week 4, Week 8, Week 12, Week 16, Week 28 | Mean change in visual acuity in the left eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline as measured by electronic visual acuity (EVA). |
| Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Baseline to Week 4, Week 8, Week 12, Week 16, Week 28 | Median change in visual acuity in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline as measured by electronic visual acuity (EVA). |
| Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Baseline to Week 4, Week 8, Week 12, Week 16, Week 28 | Median change in visual acuity in the left eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline as measured by electronic visual acuity (EVA). |
| Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits | Week 4, Week 8, Week 12, Week 16 | Number of participants in each cohort who experience a recurrence of uveitis at each follow-up visit (Week 4, Week 8, Week 12, and Week 16). Recurrence of uveitis is defined as the presence of one of the following in at least one eye: 1) new active inflammatory chorioretinal lesion and/or retinal vascular leakage; 2) a 2+ increase in anterior chamber (AC) cells relative to Baseline; 3) a 2-step increase in vitreous haze (VH) relative to Baseline; 4) worsening of best-corrected visual acuity (BCVA) by ≥ 15 letters relative to Baseline. |
| Mean Number of Days Until First Recurrence | Baseline to Week 16 | Mean number of days following the baseline injection until first recurrence (of the participants who recur). Recurrence of uveitis is defined as the presence of one of the following in at least one eye: 1) new active inflammatory chorioretinal lesion and/or retinal vascular leakage; 2) a 2+ increase in anterior chamber (AC) cells relative to Baseline; 3) a 2-step increase in vitreous haze (VH) relative to Baseline; 4) worsening of best-corrected visual acuity (BCVA) by ≥ 15 letters relative to Baseline. |
| Median Number of Days Until First Recurrence | Baseline to Week 16 | Median number of days following the baseline injection until first recurrence (of the participants who recur). Recurrence of uveitis is defined as the presence of one of the following in at least one eye: 1) new active inflammatory chorioretinal lesion and/or retinal vascular leakage; 2) a 2+ increase in anterior chamber (AC) cells relative to Baseline; 3) a 2-step increase in vitreous haze (VH) relative to Baseline; 4) worsening of best-corrected visual acuity (BCVA) by ≥ 15 letters relative to Baseline. |
| Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 4, Week 8, Week 12, Week 16, Week 28 | Presence or extent of macular edema as determined by optical coherence tomography (OCT) in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28). The number of participants that did and did not have macular edema present is presented. |
| Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4, Week 8, Week 12, Week 16, Week 28 | Presence or extent of macular edema as determined by fluorescein angiogram (FA) in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28). The number of participants that did and did not have macular edema present is presented. |
| Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4, Week 8, Week 12, Week 16, Week 28 | Presence or extent of macular edema as determined by fluorescein angiogram (FA) in the left eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28). The number of participants that did and did not have macular edema present is presented. |
| Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4, Week 8, Week 12, Week 16, Week 28 | Amount of retino-vascular leakage as measured by fluorescein angiogram (FA) in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28). The number of participants experiencing presence and new/increased lesions, presence and decreased lesions, presence and no new/increased or decreased lesions, and absence of lesions are presented. |
| Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4, Week 8, Week 12, Week 16, Week 28 | Amount of retino-vascular leakage as measured by fluorescein angiogram (FA) in the left eye at all follow-up visits (Week 4, week 8, Week 12, Week 16, and Week 28). The number of participants experiencing presence and new/increased lesions, presence and decreased lesions, presence and no new/increased or decreased lesions, and absence of lesions are presented. |
| Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Baseline to Week 4, Week 8, Week 12, Week 16, Week 28 | Mean change in central retinal thickness as measured by optical coherence tomography (OCT) in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline. |
| Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Baseline to Week 4, Week 8, Week 12, Week 16, Week 28 | Mean change in central retinal thickness as measured by optical coherence tomography (OCT) in the left eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Number and Severity of Systemic and Ocular Toxicities and Adverse Events | Baseline to Week 28 | Number and severity of systemic and ocular toxicities and adverse events for participants in both cohorts. Severity of each event is classified as mild, moderate, or severe. Natural progression of disease adverse events are not included. |
| Number of Participants Experiencing a Clinically Significant Increase in Elevated Intraocular Pressure (IOP) at Any Follow-up Visit | Week 4, Week 8, Week 12, Week 16, Week 28 | Number of participants experiencing a clinically significant increase in elevated intraocular pressure (IOP) at any follow-up visit in either eye. An increase in IOP ≥10 mmHg as compared with baseline is considered a clinically significant increase. |
| Proportion of Participants With ≥15 Letter Loss at Any Follow-up Visit. | Week 4, Week 8, Week 12, Week 16, Week 28 | Proportion of participants with ≥15 letter loss in best-corrected visual acuity (BCVA) from baseline at any follow-up visit in either eye. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Cohort 1 (Subcutaneous Only) Subcutaneous injections of Ustekinumab at baseline.
Ustekinumab: Subcutaneous Injection | 5 |
| Cohort 2 (IV and Subcutaneous) Initial IV infusion of ustekinumab at baseline followed by one subcutaneous injection at Week 8. In participants who demonstrate an allergic reaction to the baseline IV infusion, the second dose at Week 8 can also be administered as an IV infusion instead of a subcutaneous injection.
Ustekinumab: Subcutaneous Injection
Ustekinumab: Intravenous Infusion | 3 |
| Total | 8 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Insufficient Therapeutic Response | 1 | 0 |
| Overall Study | Lost to Follow-up | 0 | 1 |
Baseline characteristics
| Characteristic | Cohort 1 (Subcutaneous Only) | Cohort 2 (IV and Subcutaneous) | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 5 Participants | 3 Participants | 8 Participants |
| Age, Continuous | 51 years STANDARD_DEVIATION 9 | 48 years STANDARD_DEVIATION 9 | 50 years STANDARD_DEVIATION 9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 1 Participants | 0 Participants | 1 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 4 Participants | 3 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 3 Participants | 0 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) White | 1 Participants | 3 Participants | 4 Participants |
| Sex: Female, Male Female | 2 Participants | 1 Participants | 3 Participants |
| Sex: Female, Male Male | 3 Participants | 2 Participants | 5 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 5 | 0 / 3 |
| other Total, other adverse events | 4 / 5 | 3 / 3 |
| serious Total, serious adverse events | 0 / 5 | 0 / 3 |
Outcome results
Primary
Number of Participants Experiencing a Treatment Response by Week 16
The primary outcome is the number of participants in each cohort who experience a treatment response by Week 16. Treatment response is defined as experiencing all of the following for both/eligible eyes: no active inflammatory chorioretinal lesion and/or absent or decreased retinal vascular leakage; ≤ 0.5+ anterior chamber (AC) cells; ≤ 0.5+ vitreous haze.
Time frame: Baseline to Week 16
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (Subcutaneous Only) | Number of Participants Experiencing a Treatment Response by Week 16 | 4 Participants |
| Cohort 2 (IV and Subcutaneous) | Number of Participants Experiencing a Treatment Response by Week 16 | 2 Participants |
Secondary
Ability to Taper Concomitant Immunosuppressive Medications
The number of participants able to taper concomitant immunosuppressive medications.
Time frame: Baseline to Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in Cohort 1 is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (Subcutaneous Only) | Ability to Taper Concomitant Immunosuppressive Medications | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Ability to Taper Concomitant Immunosuppressive Medications | 0 Participants |
Secondary
Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits
Amount of retino-vascular leakage as measured by fluorescein angiogram (FA) in the left eye at all follow-up visits (Week 4, week 8, Week 12, Week 16, and Week 28). The number of participants experiencing presence and new/increased lesions, presence and decreased lesions, presence and no new/increased or decreased lesions, and absence of lesions are presented.
Time frame: Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4 | Presence and Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4 | Presence and No New/Increased or Decreased Lesions | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4 | Absence of Lesions | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Presence and Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Absence of Lesions | 4 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Presence and Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Absence of Lesions | 4 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Presence and New/Increased Lesions | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Presence and Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Absence of Lesions | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Presence and Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Absence of Lesions | 4 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Presence and Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Presence and No New/Increased or Decreased Lesions | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4 | Presence and Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Absence of Lesions | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Absence of Lesions | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4 | Absence of Lesions | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Absence of Lesions | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Presence and Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Presence and Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Absence of Lesions | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Presence and Decreased Lesions | 0 Participants |
Secondary
Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits
Amount of retino-vascular leakage as measured by fluorescein angiogram (FA) in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28). The number of participants experiencing presence and new/increased lesions, presence and decreased lesions, presence and no new/increased or decreased lesions, and absence of lesions are presented.
Time frame: Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4 | Presence and No New/Increased or Decreased Lesions | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Presence and New/Increased Lesions | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Presence and Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Absence of Lesions | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Presence and Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Absence of Lesions | 4 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4 | Presence and Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4 | Absence of Lesions | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Presence and Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Absence of Lesions | 4 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Presence and Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Absence of Lesions | 4 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Presence and No New/Increased or Decreased Lesions | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Absence of Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4 | Presence and Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Presence and No New/Increased or Decreased Lesions | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Presence and Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4 | Absence of Lesions | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Presence and No New/Increased or Decreased Lesions | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Absence of Lesions | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Absence of Lesions | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Presence and New/Increased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Presence and Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Presence and Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Presence and No New/Increased or Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Presence and Decreased Lesions | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Absence of Lesions | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Amount of Retino-vascular Leakage as Measured by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Presence and New/Increased Lesions | 0 Participants |
Secondary
Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline
Mean change in central retinal thickness as measured by optical coherence tomography (OCT) in the left eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline.
Time frame: Baseline to Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Week 8 | 17 micrometers | Standard Deviation 34 |
| Cohort 1 (Subcutaneous Only) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Week 16 | -2 micrometers | Standard Deviation 31 |
| Cohort 1 (Subcutaneous Only) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Week 12 | 54 micrometers | Standard Deviation 87 |
| Cohort 1 (Subcutaneous Only) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Week 28 | -1 micrometers | Standard Deviation 24 |
| Cohort 1 (Subcutaneous Only) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Week 4 | -13 micrometers | Standard Deviation 26 |
| Cohort 2 (IV and Subcutaneous) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Week 28 | 19 micrometers | Standard Deviation 6 |
| Cohort 2 (IV and Subcutaneous) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Week 4 | 1 micrometers | Standard Deviation 1 |
| Cohort 2 (IV and Subcutaneous) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Week 8 | -1 micrometers | Standard Deviation 6 |
| Cohort 2 (IV and Subcutaneous) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Week 12 | 2 micrometers | Standard Deviation 4 |
| Cohort 2 (IV and Subcutaneous) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits Compared to Baseline | Week 16 | 8 micrometers | Standard Deviation 6 |
Secondary
Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline
Mean change in central retinal thickness as measured by optical coherence tomography (OCT) in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline.
Time frame: Baseline to Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Week 8 | -49 micrometers | Standard Deviation 95 |
| Cohort 1 (Subcutaneous Only) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Week 16 | -28 micrometers | Standard Deviation 16 |
| Cohort 1 (Subcutaneous Only) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Week 12 | -11 micrometers | Standard Deviation 13 |
| Cohort 1 (Subcutaneous Only) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Week 28 | -9 micrometers | Standard Deviation 40 |
| Cohort 1 (Subcutaneous Only) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Week 4 | 8 micrometers | Standard Deviation 14 |
| Cohort 2 (IV and Subcutaneous) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Week 28 | -2 micrometers | Standard Deviation 11 |
| Cohort 2 (IV and Subcutaneous) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Week 4 | -2 micrometers | Standard Deviation 4 |
| Cohort 2 (IV and Subcutaneous) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Week 8 | -6 micrometers | Standard Deviation 12 |
| Cohort 2 (IV and Subcutaneous) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Week 12 | 6 micrometers | Standard Deviation 1 |
| Cohort 2 (IV and Subcutaneous) | Changes in Central Retinal Thickness as Measured by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits Compared to Baseline | Week 16 | -7 micrometers | Standard Deviation 16 |
Secondary
Length of Time to Quiescence in the Left Eye
Mean length of time to first experience of quiescence in the left eye. Quiescence refers to absence of active disease defined as not having the following conditions: +1 or more vitreous haze; and/or active chorioretinitis or leakage on fluorescein angiogram (FA) (that is more than one quadrant) that requires treatment.
Time frame: Baseline to Week 16
Population: All enrolled participants who received at least one dose of Ustekinumab, completed the Week 16 visit, and experienced quiescence. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16. An additional participant in Cohort 1 is excluded due to not experiencing quiescence.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Length of Time to Quiescence in the Left Eye | 38 days | Standard Deviation 16 |
| Cohort 2 (IV and Subcutaneous) | Length of Time to Quiescence in the Left Eye | 38 days | Standard Deviation 8 |
Secondary
Length of Time to Quiescence in the Right Eye
Mean length of time to first experience of quiescence in the right eye. Quiescence refers to absence of active disease defined as not having the following conditions: +1 or more vitreous haze; and/or active chorioretinitis or leakage on fluorescein angiogram (FA) (that is more than one quadrant) that requires treatment.
Time frame: Baseline to Week 16
Population: All enrolled participants who received at least one dose of Ustekinumab, completed the Week 16 visit, and experienced quiescence. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16. An additional participant in Cohort 1 is excluded due to not experiencing quiescence.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Length of Time to Quiescence in the Right Eye | 24 days | Standard Deviation 8 |
| Cohort 2 (IV and Subcutaneous) | Length of Time to Quiescence in the Right Eye | 38 days | Standard Deviation 8 |
Secondary
Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline
Mean change in visual acuity in the left eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline as measured by electronic visual acuity (EVA).
Time frame: Baseline to Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16. At Week 28, one additional participant in Cohort 2 is excluded from the analysis due to missing visual acuity data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 8 | 4 letters read | Standard Deviation 5 |
| Cohort 1 (Subcutaneous Only) | Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 16 | 0 letters read | Standard Deviation 13 |
| Cohort 1 (Subcutaneous Only) | Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 12 | 4 letters read | Standard Deviation 6 |
| Cohort 1 (Subcutaneous Only) | Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 28 | 6 letters read | Standard Deviation 10 |
| Cohort 1 (Subcutaneous Only) | Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 4 | -2 letters read | Standard Deviation 7 |
| Cohort 2 (IV and Subcutaneous) | Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 28 | -5 letters read | — |
| Cohort 2 (IV and Subcutaneous) | Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 4 | 1 letters read | Standard Deviation 4 |
| Cohort 2 (IV and Subcutaneous) | Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 8 | 1 letters read | Standard Deviation 2 |
| Cohort 2 (IV and Subcutaneous) | Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 12 | 1 letters read | Standard Deviation 2 |
| Cohort 2 (IV and Subcutaneous) | Mean Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 16 | 0 letters read | Standard Deviation 0 |
Secondary
Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline
Mean change in visual acuity in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline as measured by electronic visual acuity (EVA).
Time frame: Baseline to Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16. At Week 28, one additional participant in Cohort 2 is excluded from the analysis due to missing visual acuity data.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 12 | 2 letters read | Standard Deviation 4 |
| Cohort 1 (Subcutaneous Only) | Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 16 | 1 letters read | Standard Deviation 8 |
| Cohort 1 (Subcutaneous Only) | Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 8 | 1 letters read | Standard Deviation 3 |
| Cohort 1 (Subcutaneous Only) | Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 28 | -2 letters read | Standard Deviation 7 |
| Cohort 1 (Subcutaneous Only) | Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 4 | -1 letters read | Standard Deviation 3 |
| Cohort 2 (IV and Subcutaneous) | Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 28 | -1 letters read | — |
| Cohort 2 (IV and Subcutaneous) | Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 4 | -1 letters read | Standard Deviation 1 |
| Cohort 2 (IV and Subcutaneous) | Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 8 | 1 letters read | Standard Deviation 4 |
| Cohort 2 (IV and Subcutaneous) | Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 12 | 0 letters read | Standard Deviation 3 |
| Cohort 2 (IV and Subcutaneous) | Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 16 | 0 letters read | Standard Deviation 1 |
Secondary
Mean Number of Days Until First Recurrence
Mean number of days following the baseline injection until first recurrence (of the participants who recur). Recurrence of uveitis is defined as the presence of one of the following in at least one eye: 1) new active inflammatory chorioretinal lesion and/or retinal vascular leakage; 2) a 2+ increase in anterior chamber (AC) cells relative to Baseline; 3) a 2-step increase in vitreous haze (VH) relative to Baseline; 4) worsening of best-corrected visual acuity (BCVA) by ≥ 15 letters relative to Baseline.
Time frame: Baseline to Week 16
Population: All enrolled participants who received at least one dose of Ustekinumab, completed the Week 16 visit, and experienced recurrence of uveitis. As only one participant experienced recurrence of uveitis, only one participant from Cohort 1 is included in the analysis.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Cohort 1 (Subcutaneous Only) | Mean Number of Days Until First Recurrence | 118 days |
Secondary
Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline
Median change in visual acuity in the left eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline as measured by electronic visual acuity (EVA).
Time frame: Baseline to Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16. At Week 28, one additional participant in Cohort 2 is excluded from the analysis due to missing visual acuity data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 8 | 2 letters read |
| Cohort 1 (Subcutaneous Only) | Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 16 | 1 letters read |
| Cohort 1 (Subcutaneous Only) | Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 12 | 3 letters read |
| Cohort 1 (Subcutaneous Only) | Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 28 | 3 letters read |
| Cohort 1 (Subcutaneous Only) | Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 4 | -2 letters read |
| Cohort 2 (IV and Subcutaneous) | Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 28 | -5 letters read |
| Cohort 2 (IV and Subcutaneous) | Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 4 | 1 letters read |
| Cohort 2 (IV and Subcutaneous) | Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 8 | 1 letters read |
| Cohort 2 (IV and Subcutaneous) | Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 12 | 1 letters read |
| Cohort 2 (IV and Subcutaneous) | Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline | Week 16 | 0 letters read |
Secondary
Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline
Median change in visual acuity in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28) compared to baseline as measured by electronic visual acuity (EVA).
Time frame: Baseline to Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16. At Week 28, one additional participant in Cohort 2 is excluded from the analysis due to missing visual acuity data.
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 4 | -1 letters read |
| Cohort 1 (Subcutaneous Only) | Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 16 | 4 letters read |
| Cohort 1 (Subcutaneous Only) | Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 8 | 2 letters read |
| Cohort 1 (Subcutaneous Only) | Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 28 | 1 letters read |
| Cohort 1 (Subcutaneous Only) | Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 12 | 3 letters read |
| Cohort 2 (IV and Subcutaneous) | Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 28 | -1 letters read |
| Cohort 2 (IV and Subcutaneous) | Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 8 | 1 letters read |
| Cohort 2 (IV and Subcutaneous) | Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 12 | 0 letters read |
| Cohort 2 (IV and Subcutaneous) | Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 16 | 0 letters read |
| Cohort 2 (IV and Subcutaneous) | Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Week 4 | -1 letters read |
Secondary
Median Number of Days Until First Recurrence
Median number of days following the baseline injection until first recurrence (of the participants who recur). Recurrence of uveitis is defined as the presence of one of the following in at least one eye: 1) new active inflammatory chorioretinal lesion and/or retinal vascular leakage; 2) a 2+ increase in anterior chamber (AC) cells relative to Baseline; 3) a 2-step increase in vitreous haze (VH) relative to Baseline; 4) worsening of best-corrected visual acuity (BCVA) by ≥ 15 letters relative to Baseline.
Time frame: Baseline to Week 16
Population: All enrolled participants who received at least one dose of Ustekinumab, completed the Week 16 visit, and experienced recurrence of uveitis. As only one participant experienced recurrence of uveitis, only one participant from Cohort 1 is included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Cohort 1 (Subcutaneous Only) | Median Number of Days Until First Recurrence | 118 days |
Secondary
Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits
Number of participants in each cohort who experience a recurrence of uveitis at each follow-up visit (Week 4, Week 8, Week 12, and Week 16). Recurrence of uveitis is defined as the presence of one of the following in at least one eye: 1) new active inflammatory chorioretinal lesion and/or retinal vascular leakage; 2) a 2+ increase in anterior chamber (AC) cells relative to Baseline; 3) a 2-step increase in vitreous haze (VH) relative to Baseline; 4) worsening of best-corrected visual acuity (BCVA) by ≥ 15 letters relative to Baseline.
Time frame: Week 4, Week 8, Week 12, Week 16
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits | Week 8 | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits | Week 4 | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits | Week 12 | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits | Week 16 | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits | Week 16 | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits | Week 8 | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits | Week 12 | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits | Week 4 | 0 Participants |
Secondary
Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits
Presence or extent of macular edema as determined by fluorescein angiogram (FA) in the left eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28). The number of participants that did and did not have macular edema present is presented.
Time frame: Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16. No participants in Cohort 2 were analyzed at Week 4 as neither had FA performed at that visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Present | 2 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Not Present | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Present | 4 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4 | Not Present | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Not Present | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 4 | Present | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Not Present | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Not Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 8 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 12 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Present | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 16 | Not Present | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Left Eye at All Follow-up Visits | Week 28 | Present | 2 Participants |
Secondary
Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits
Presence or extent of macular edema as determined by fluorescein angiogram (FA) in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28). The number of participants that did and did not have macular edema present is presented.
Time frame: Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16. No participants in Cohort 2 were analyzed at Week 4 as neither had FA performed at that visit.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Present | 4 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Not Present | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4 | Not Present | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Not Present | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 4 | Present | 2 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Not Present | 0 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Not Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Not Present | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 8 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 12 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 16 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Fluorescein Angiogram (FA) in the Right Eye at All Follow-up Visits | Week 28 | Present | 1 Participants |
Secondary
Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits
Presence or extent of macular edema as determined by optical coherence tomography (OCT) in the left eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28). The number of participants that did and did not have macular edema present is presented.
Time frame: Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 28 | Present | 2 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 4 | Not Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 8 | Not Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 16 | Present | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 28 | Not Present | 2 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 8 | Present | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 12 | Present | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 12 | Not Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 16 | Not Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 4 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 12 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 4 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 8 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 4 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 8 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 16 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 12 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 28 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 16 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Left Eye at All Follow-up Visits | Week 28 | Not Present | 2 Participants |
Secondary
Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits
Presence or extent of macular edema as determined by optical coherence tomography (OCT) in the right eye at all follow-up visits (Week 4, Week 8, Week 12, Week 16, and Week 28). The number of participants that did and did not have macular edema present is presented.
Time frame: Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 4 | Present | 2 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 4 | Not Present | 2 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 8 | Present | 2 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 8 | Not Present | 2 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 12 | Present | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 12 | Not Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 16 | Present | 1 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 16 | Not Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 28 | Present | 3 Participants |
| Cohort 1 (Subcutaneous Only) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 28 | Not Present | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 16 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 4 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 12 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 4 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 28 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 8 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 16 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 8 | Not Present | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 28 | Present | 0 Participants |
| Cohort 2 (IV and Subcutaneous) | Presence or Extent of Macular Edema as Determined by Optical Coherence Tomography (OCT) in the Right Eye at All Follow-up Visits | Week 12 | Present | 0 Participants |
Other Pre-specified
Number and Severity of Systemic and Ocular Toxicities and Adverse Events
Number and severity of systemic and ocular toxicities and adverse events for participants in both cohorts. Severity of each event is classified as mild, moderate, or severe. Natural progression of disease adverse events are not included.
Time frame: Baseline to Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Cohort 1 (Subcutaneous Only) | Number and Severity of Systemic and Ocular Toxicities and Adverse Events | Mild | 10 adverse events |
| Cohort 1 (Subcutaneous Only) | Number and Severity of Systemic and Ocular Toxicities and Adverse Events | Moderate | 3 adverse events |
| Cohort 1 (Subcutaneous Only) | Number and Severity of Systemic and Ocular Toxicities and Adverse Events | Severe | 0 adverse events |
| Cohort 2 (IV and Subcutaneous) | Number and Severity of Systemic and Ocular Toxicities and Adverse Events | Mild | 7 adverse events |
| Cohort 2 (IV and Subcutaneous) | Number and Severity of Systemic and Ocular Toxicities and Adverse Events | Moderate | 3 adverse events |
| Cohort 2 (IV and Subcutaneous) | Number and Severity of Systemic and Ocular Toxicities and Adverse Events | Severe | 0 adverse events |
Other Pre-specified
Number of Participants Experiencing a Clinically Significant Increase in Elevated Intraocular Pressure (IOP) at Any Follow-up Visit
Number of participants experiencing a clinically significant increase in elevated intraocular pressure (IOP) at any follow-up visit in either eye. An increase in IOP ≥10 mmHg as compared with baseline is considered a clinically significant increase.
Time frame: Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (Subcutaneous Only) | Number of Participants Experiencing a Clinically Significant Increase in Elevated Intraocular Pressure (IOP) at Any Follow-up Visit | 2 Participants |
| Cohort 2 (IV and Subcutaneous) | Number of Participants Experiencing a Clinically Significant Increase in Elevated Intraocular Pressure (IOP) at Any Follow-up Visit | 0 Participants |
Other Pre-specified
Proportion of Participants With ≥15 Letter Loss at Any Follow-up Visit.
Proportion of participants with ≥15 letter loss in best-corrected visual acuity (BCVA) from baseline at any follow-up visit in either eye.
Time frame: Week 4, Week 8, Week 12, Week 16, Week 28
Population: All enrolled participants who received at least one dose of Ustekinumab and completed the Week 16 visit. One participant in each cohort is excluded from the analysis as a result of discontinuing the study prior to Week 16.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Cohort 1 (Subcutaneous Only) | Proportion of Participants With ≥15 Letter Loss at Any Follow-up Visit. | 1 Participants |
| Cohort 2 (IV and Subcutaneous) | Proportion of Participants With ≥15 Letter Loss at Any Follow-up Visit. | 0 Participants |