Trial Outcomes & Findings for Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis (STAR Study) (NCT NCT02911116)

Last Updated: 2021-03-26

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

8 participants

Primary outcome timeframe

Baseline to Week 16

Results posted on

2021-03-26

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1 (Subcutaneous Only) Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	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
Overall Study STARTED	5	3
Overall Study COMPLETED	4	2
Overall Study NOT COMPLETED	1	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Cohort 1 (Subcutaneous Only) Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	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
Overall Study Insufficient Therapeutic Response	1	0
Overall Study Lost to Follow-up	0	1

Baseline Characteristics

Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis (STAR Study)

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Baseline to Week 16

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
Number of Participants Experiencing a Treatment Response by Week 16	4 Participants	2 Participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
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	-1 letters read Standard Deviation 1
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	1 letters read Standard Deviation 4
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	0 letters read Standard Deviation 3
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	0 letters read Standard Deviation 1
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	-1 letters read Standard Deviation NA Only one participant was analyzed for Cohort 2 at Week 28, so the standard deviation could not be calculated.

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
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	1 letters read Standard Deviation 4
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	1 letters read Standard Deviation 2
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	1 letters read Standard Deviation 2
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	0 letters read Standard Deviation 0
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	-5 letters read Standard Deviation NA Only one participant was analyzed for Cohort 2 at Week 28, so the standard deviation could not be calculated.

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline Week 28	1 letters read Interval -12.0 to 4.0	-1 letters read Interval -1.0 to -1.0
Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline Week 4	-1 letters read Interval -4.0 to 2.0	-1 letters read Interval -1.0 to 0.0
Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline Week 8	2 letters read Interval -3.0 to 3.0	1 letters read Interval -2.0 to 3.0
Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline Week 12	3 letters read Interval -2.0 to 5.0	0 letters read Interval -2.0 to 2.0
Median Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline Week 16	4 letters read Interval -10.0 to 7.0	0 letters read Interval -1.0 to 1.0

SECONDARY outcome

Timeframe: 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).

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline Week 4	-2 letters read Interval -9.0 to 5.0	1 letters read Interval -2.0 to 4.0
Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline Week 8	2 letters read Interval -1.0 to 11.0	1 letters read Interval -1.0 to 2.0
Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline Week 12	3 letters read Interval -3.0 to 12.0	1 letters read Interval -1.0 to 2.0
Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline Week 16	1 letters read Interval -16.0 to 15.0	0 letters read Interval 0.0 to 0.0
Median Change in Visual Acuity in the Left Eye at All Follow-up Visits Compared to Baseline Week 28	3 letters read Interval -3.0 to 20.0	-5 letters read Interval -5.0 to -5.0

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits Week 4	0 Participants	0 Participants
Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits Week 8	0 Participants	0 Participants
Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits Week 12	0 Participants	0 Participants
Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits Week 16	1 Participants	0 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=1 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	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
Mean Number of Days Until First Recurrence	118 days Standard Deviation NA There was only participant analyzed for Cohort 1, so the standard deviation could not be calculated.	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=1 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	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
Median Number of Days Until First Recurrence	118 days Interval 118.0 to 118.0	—

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
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	—
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	—
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants
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	1 Participants
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	1 Participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
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	—
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	—
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	0 Participants
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	2 Participants
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	0 Participants
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	2 Participants
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	1 Participants
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	1 Participants
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	2 Participants
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	0 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
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	0 Participants
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	0 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	0 Participants
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	1 Participants
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	1 Participants
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	0 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	1 Participants
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	1 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
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	0 Participants
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	0 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	0 Participants
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	1 Participants
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	1 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	2 Participants
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	0 Participants
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	0 Participants
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	0 Participants
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	2 Participants

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
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	-2 micrometers Standard Deviation 4
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	-6 micrometers Standard Deviation 12
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	6 micrometers Standard Deviation 1
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	-7 micrometers Standard Deviation 16
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	-2 micrometers Standard Deviation 11

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
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	1 micrometers Standard Deviation 1
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	-1 micrometers Standard Deviation 6
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	2 micrometers Standard Deviation 4
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	8 micrometers Standard Deviation 6
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	19 micrometers Standard Deviation 6

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=3 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
Length of Time to Quiescence in the Right Eye	24 days Standard Deviation 8	38 days Standard Deviation 8

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=3 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
Length of Time to Quiescence in the Left Eye	38 days Standard Deviation 16	38 days Standard Deviation 8

SECONDARY outcome

Timeframe: 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.

The number of participants able to taper concomitant immunosuppressive medications.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
Ability to Taper Concomitant Immunosuppressive Medications	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
Number of Participants Experiencing a Clinically Significant Increase in Elevated Intraocular Pressure (IOP) at Any Follow-up Visit	2 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
Proportion of Participants With ≥15 Letter Loss at Any Follow-up Visit.	1 Participants	0 Participants

OTHER_PRE_SPECIFIED outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Cohort 1 (Subcutaneous Only) n=4 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=2 Participants 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
Number and Severity of Systemic and Ocular Toxicities and Adverse Events Mild	10 adverse events	7 adverse events
Number and Severity of Systemic and Ocular Toxicities and Adverse Events Moderate	3 adverse events	3 adverse events
Number and Severity of Systemic and Ocular Toxicities and Adverse Events Severe	0 adverse events	0 adverse events

Adverse Events

Cohort 1 (Subcutaneous Only)

Serious events: 0 serious events

Other events: 4 other events

Deaths: 0 deaths

Cohort 2 (IV and Subcutaneous)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	Cohort 1 (Subcutaneous Only) n=5 participants at risk Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=3 participants at risk 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
Cardiac disorders Tachycardia	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Eye disorders conjunctivitis allergic	0.00% 0/5 • 28 weeks	33.3% 1/3 • Number of events 1 • 28 weeks
Eye disorders Keratitis	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Gastrointestinal disorders Diarrhoea	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Gastrointestinal disorders Dyspepsia	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
General disorders Adverse drug reaction	0.00% 0/5 • 28 weeks	33.3% 1/3 • Number of events 1 • 28 weeks
General disorders Fatigue	0.00% 0/5 • 28 weeks	33.3% 1/3 • Number of events 1 • 28 weeks
General disorders Pyrexia	0.00% 0/5 • 28 weeks	33.3% 1/3 • Number of events 1 • 28 weeks
Infections and infestations Upper respiratory tract infection	40.0% 2/5 • Number of events 2 • 28 weeks	0.00% 0/3 • 28 weeks
Infections and infestations Urinary tract infection	0.00% 0/5 • 28 weeks	33.3% 1/3 • Number of events 1 • 28 weeks
Injury, poisoning and procedural complications Fall	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Injury, poisoning and procedural complications Upper limb fracture	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Investigations Blood pressure increased	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Investigations Neutrophil count decreased	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Investigations Vitamin D decreased	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Investigations White blood cell count decreased	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Musculoskeletal and connective tissue disorders Myalgia	0.00% 0/5 • 28 weeks	66.7% 2/3 • Number of events 2 • 28 weeks
Nervous system disorders Neuropathy peripheral	0.00% 0/5 • 28 weeks	33.3% 1/3 • Number of events 1 • 28 weeks
Nervous system disorders Paraesthesia	0.00% 0/5 • 28 weeks	33.3% 1/3 • Number of events 1 • 28 weeks
Psychiatric disorders Depression	0.00% 0/5 • 28 weeks	33.3% 1/3 • Number of events 1 • 28 weeks
Skin and subcutaneous tissue disorders Acne	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Surgical and medical procedures Polypectomy	0.00% 0/5 • 28 weeks	33.3% 1/3 • Number of events 1 • 28 weeks
Vascular disorders Phlebitis	0.00% 0/5 • 28 weeks	33.3% 1/3 • Number of events 1 • 28 weeks
Eye disorders Visual acuity reduced	40.0% 2/5 • Number of events 2 • 28 weeks	0.00% 0/3 • 28 weeks
Eye disorders Vitreous floaters	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Eye disorders Ocular hyperaemia	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Eye disorders Subretinal fluid	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks
Eye disorders Cystoid macular oedema	20.0% 1/5 • Number of events 2 • 28 weeks	0.00% 0/3 • 28 weeks
Eye disorders Iris adhesions	20.0% 1/5 • Number of events 1 • 28 weeks	0.00% 0/3 • 28 weeks

Additional Information

H. Nida Sen, MD, MHSc, Principal Investigator, NEI

National Institutes of Health

Phone: 301-402-3254

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1 (Subcutaneous Only) n=5 Participants Subcutaneous injections of Ustekinumab at baseline. Ustekinumab: Subcutaneous Injection	Cohort 2 (IV and Subcutaneous) n=3 Participants 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	Total n=8 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	3 Participants n=7 Participants	8 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Continuous	51 years STANDARD_DEVIATION 9 • n=5 Participants	48 years STANDARD_DEVIATION 9 • n=7 Participants	50 years STANDARD_DEVIATION 9 • n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants	1 Participants n=7 Participants	3 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants	2 Participants n=7 Participants	5 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	3 Participants n=5 Participants	0 Participants n=7 Participants	3 Participants n=5 Participants
Race (NIH/OMB) White	1 Participants n=5 Participants	3 Participants n=7 Participants	4 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants