Trial · NCT02911116
Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis (STAR Study)
NCT02911116, Phase 2, Completed, National Eye Institute (NEI); results first posted 2021-03-26
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis (STAR Study). Trials, record NCT02911116. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02911116
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Ustekinumab (STELARA) for the Treatment of Active Sight-Threatening Uveitis (STAR Study)
- NCT number
- NCT02911116
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 8 participants, actual
- Lead sponsor
- National Eye Institute (NEI)
- Conditions
- Uveitis
- Interventions
- Ustekinumab, Ustekinumab
- First posted
- 2016-09-22
- Last updated
- 2021-03-26
- Results first posted
- 2021-03-26
Source ClinicalTrials.gov
Registered outcomes22
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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). |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
| Secondary | 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. |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 registered outcomesOutcomes22
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Experiencing a Treatment Response by Week 16 | Baseline to Week 16 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 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. | letters read | MEAN |
| SECONDARY | 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 | 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. | letters read | MEAN |
| SECONDARY | 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 | 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. | letters read | MEDIAN |
| SECONDARY | 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 | 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. | letters read | MEDIAN |
| SECONDARY | Number of Participants Who Experience a Recurrence of Uveitis at All Follow-up Visits | Week 4, Week 8, Week 12, Week 16 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Number of Days Until First Recurrence | Baseline to Week 16 | 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. | days | MEAN |
| SECONDARY | Median Number of Days Until First Recurrence | Baseline to Week 16 | 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. | days | MEDIAN |
| SECONDARY | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | 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 | 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. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 22Source ClinicalTrials.gov
See all 22 outcomesResults by group244
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Experiencing a Treatment Response by Week 16 | Cohort 1 (Subcutaneous Only) | 4 | Participants | ||
| Number of Participants Experiencing a Treatment Response by Week 16 | Cohort 2 (IV and Subcutaneous) | 2 | Participants | ||
| Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Cohort 1 (Subcutaneous Only) | Week 4 | -1 | Standard Deviation 3 | letters read |
| Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Cohort 2 (IV and Subcutaneous) | Week 4 | -1 | Standard Deviation 1 | letters read |
| Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Cohort 1 (Subcutaneous Only) | Week 8 | 1 | Standard Deviation 3 | letters read |
| Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Cohort 2 (IV and Subcutaneous) | Week 8 | 1 | Standard Deviation 4 | letters read |
| Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Cohort 1 (Subcutaneous Only) | Week 12 | 2 | Standard Deviation 4 | letters read |
| Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Cohort 2 (IV and Subcutaneous) | Week 12 | 0 | Standard Deviation 3 | letters read |
| Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Cohort 1 (Subcutaneous Only) | Week 16 | 1 | Standard Deviation 8 | letters read |
| Mean Change in Visual Acuity in the Right Eye at All Follow-up Visits Compared to Baseline | Cohort 2 (IV and Subcutaneous) | Week 16 | 0 | Standard Deviation 1 | letters read |
1 to 10 of 244Source ClinicalTrials.gov
See all 244 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Cohort 1 (Subcutaneous Only) | 5 | |
| Overall Study | STARTED | Cohort 2 (IV and Subcutaneous) | 3 | |
| Overall Study | COMPLETED | Cohort 1 (Subcutaneous Only) | 4 | |
| Overall Study | COMPLETED | Cohort 2 (IV and Subcutaneous) | 2 | |
| Overall Study | NOT COMPLETED | Cohort 1 (Subcutaneous Only) | 1 | |
| Overall Study | NOT COMPLETED | Cohort 2 (IV and Subcutaneous) | 1 |
Source ClinicalTrials.gov
Adverse events58
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Tachycardia | Cardiac disorders | Cohort 1 (Subcutaneous Only) | 1 | 5 | 1 |
| other | Tachycardia | Cardiac disorders | Cohort 2 (IV and Subcutaneous) | 0 | 3 | 0 |
| other | conjunctivitis allergic | Eye disorders | Cohort 1 (Subcutaneous Only) | 0 | 5 | 0 |
| other | conjunctivitis allergic | Eye disorders | Cohort 2 (IV and Subcutaneous) | 1 | 3 | 1 |
| other | Keratitis | Eye disorders | Cohort 1 (Subcutaneous Only) | 1 | 5 | 1 |
| other | Keratitis | Eye disorders | Cohort 2 (IV and Subcutaneous) | 0 | 3 | 0 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 1 (Subcutaneous Only) | 1 | 5 | 1 |
| other | Diarrhoea | Gastrointestinal disorders | Cohort 2 (IV and Subcutaneous) | 0 | 3 | 0 |
| other | Dyspepsia | Gastrointestinal disorders | Cohort 1 (Subcutaneous Only) | 1 | 5 | 1 |
| other | Dyspepsia | Gastrointestinal disorders | Cohort 2 (IV and Subcutaneous) | 0 | 3 | 0 |
1 to 10 of 58Source ClinicalTrials.gov
See all 58 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Cohort 1 (Subcutaneous Only) | 0 | 5 |
| Total, all-cause mortality | Cohort 2 (IV and Subcutaneous) | 0 | 3 |
| Total, other adverse events | Cohort 1 (Subcutaneous Only) | 4 | 5 |
| Total, other adverse events | Cohort 2 (IV and Subcutaneous) | 3 | 3 |
| Total, serious adverse events | Cohort 1 (Subcutaneous Only) | 0 | 5 |
| Total, serious adverse events | Cohort 2 (IV and Subcutaneous) | 0 | 3 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Cohort 1 (Subcutaneous Only) vs Cohort 2 (IV and Subcutaneous): Proportion of Participants With ≥15 Letter Loss at Any Follow-up Visit. | Trial comparisons |
| Cohort 1 (Subcutaneous Only) vs Cohort 2 (IV and Subcutaneous): Ability to Taper Concomitant Immunosuppressive Medications | Trial comparisons |
| Cohort 1 (Subcutaneous Only) vs Cohort 2 (IV and Subcutaneous): Number of Participants Experiencing a Treatment Response by Week 16 | Trial comparisons |
| Cohort 1 (Subcutaneous Only) vs Cohort 2 (IV and Subcutaneous): Number of Participants Experiencing a Clinically Significant Increase in Elevated Intraocular Pressure (IOP) at Any Follow-up Visit | Trial comparisons |
| Cohort 1 (Subcutaneous Only) vs Cohort 2 (IV and Subcutaneous): deaths from any cause | Trial comparisons |
| Cohort 1 (Subcutaneous Only) vs Cohort 2 (IV and Subcutaneous): serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02911116
GET https://conductscience.org/api/trials/v1/NCT02911116/registered?page=2