Registered outcomes15

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

1 to 15 of 15

List	Outcome	Time frame	Description
Primary	Corticosteroid-sparing Treatment Success Within the First 6 Months After Randomization	6 months	Corticosteroid-sparing success is defined as achieving inactive uveitis for two consecutive visits \>= 28 days apart while on \<= 7.5 mg/day of corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging. Steroid dose and uveitis activity from visit months 6,8,10 and 12 were included in the analysis. Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. Results were reported at 6 months (primary outcome) and 12 months (secondary outcome).
Secondary	Corticosteroid-sparing Treatment Success Within the First 12 Months After Randomization	12 months	Corticosteroid-sparing success is defined as achieving inactive uveitis for two consecutive visits \>= 28 days apart while on \<= 7.5 mg/day of corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging. Steroid dose and uveitis activity from visit months 6,8,10 and 12 were included in the analysis. Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid sparing between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. Results were reported at 6 months (primary outcome) and 12 months (secondary outcome).
Secondary	Corticosteroid Discontinuation Success by 6 Months	6 months	Corticosteroid discontinuation success is defined as achieving inactive uveitis for two consecutive visits \>= 28 days apart after discontinuing corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging. Steroid dose and uveitis activity from visit months 6,8,10 and 12 were included in the analysis. Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid discontinuation between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. Results were reported at 6 months and 12 months.
Secondary	Corticosteroid Discontinuation Success by 12 Months	12 months	Corticosteroid discontinuation success is defined as achieving inactive uveitis for two consecutive visits \>= 28 days apart after discontinuing corticosteroids. Uveitis status (active vs inactive) is determined by the study ophthalmologist after reviewing the eye exam and imaging. Steroid dose and uveitis activity from visit months 6,8,10 and 12 were included in the analysis. Generalized estimating equations were used to fit logistic regression models to compare the cumulative proportion of corticosteroid discontinuation between the two treatment groups over time while accounting for correlation between replicate measurements on the same individual with an unstructured covariance matrix. Results were reported at 6 months and 12 months.
Secondary	Corticosteroid Exposure Over 12 Months	12 months	Corticosteroid dose was collected at baseline and months 1,2,3,4,5,6,8,10, and 12. Mean corticosteroid dose per day was estimated with a negative binomial model at 12 months.
Secondary	Best Corrected Visual Acuity Change at 12 Months	12 months	Mean change in best-corrected visual acuity from baseline to 12 months. Participants' visual acuity was measured by certified examiners with best refractive correction in place. Participants were challenged with reading letters on lines of the standard ETDRS eye chart (5 letters per line). Lines became smaller as participants progressed from the top to the bottom of the chart. Participants read down the chart until no more meaningful readings could be made and were scored by how many letters could be correctly identified. More letters read is associated with higher visual acuity (85 letters is 20/20 vision). Visual acuity data was collected at baseline and months 1,2,3,4,5,6,8,10, and 12 and estimated at 12 months with a mixed model.
Secondary	Macular Edema Over 12 Months of Follow up	12 months	Macular edema is defined as central retinal thickness greater than or equal to 300 micrometers as measured by a masked grader's review of OCT images. Greater retinal thickness is associated with poorer vision. Outcome measure is the odds ratio comparing macular edema at 12 months to baseline macular edema. Macular edema was measured at baseline and months 3, 6, and 12. The odds ratio at 12 months was estimated with a mixed model.
Secondary	Incidence of Infections at 12 Months	12 months	Incidence of infections over 12 months of follow-up. Participants were asked about occurrences since the previous visit of infections requiring antibiotic or antiviral treatment. Data was collected at months 1,2,3,4,5,6,8,10, and 12. The rate of infections at 12 months was estimated with a negative binomial model.
Secondary	Elevated Levels of AST or ALT (Hepatoxicity) by 12 Months.	12 months	Cumulative percent of participants having elevated levels of aspartate aminotransferase (AST) or alanine transaminase (ALT) greater than twice the upper level of normal by 12 months. Elevated levels of AST and ALT may indicate decline in liver function. Lab values of AST and ALT were measured at baseline and months 1,2,3,4,5,6,8,10, and 12 and the cumulative percent of participants with elevated lab values by 12 months was estimated by Kaplan Meier methods.
Secondary	Elevated Creatine (Nephrotoxicity) by 12 Months	12 months	Cumulative percent of participants having elevated creatine values (creatine greater than 30% above baseline or creatine \> 1.5 mg/dL) by 12 months. Increases in creatine levels may indicate decreased kidney function. Lab values of creatine were measured at baseline and months 1,2,3,4,5,6,8,10, and 12 and the cumulative percent of participants with elevated creatine at 12 months was estimated by Kaplan Meier methods.
Secondary	EQ-5D (Health Utility)	12 months	The EQ-5D (EuroQol Group - 5 Dimension questionnaire) is a participant reported validated questionnaire that measures the patient's health status in five dimensions of health: mobility, self-care, usual activities, pain and discomfort, and anxiety and depression. The range of questionnaire index scores is -0.59 to 1 where score of 1 indicates best possible health. The outcome measure is the odds of having EQ-5D score of 1 (perfect health) at 12 months compared to the odds of having EQ-5d score = 1 at the baseline visit. Participants completed the EQ-5D questionnaire at baseline and months 3, 6 and 12. General estimating equations with a log link were used to assess the odds ratio at 12 months.
Secondary	General Health-related Quality of Life -Physical Component (SF-36)	12 months	Standard Form 36 item (SF-36) questionnaire is a validated participant reported measure of health related-quality of life. The physical component summary (PCS) is a score derived from the SF-36 that reflects a person's physical well-being. Range of scores is 0 to 100. Higher scores indicated better physical health. The minimally important clinical difference is 3-5 points. Outcome measure is the change in physical health score from baseline to 12 months. Participants completed the questionnaire at baseline and months 3, 6, and 12. The mean change from baseline at 12 months was estimated with a mixed model.
Secondary	Quality of Life Mental Health Component Standard Form 36 Item (SF-36)	12 months	Standard Form 36 item (SF-36) questionnaire is a validated participant reported measure of health related-quality of life. The mental health component summary (MCS) is a score derived from the SF-36 that reflects a person's mental health and well-being. Range of scores is 0 to 100. Higher scores indicate better mental health. The minimally important clinical difference is 3-5 points. Outcome measure is the change in mental health score from baseline to 12 months. Participants completed the questionnaire at baseline and months 3, 6, and 12. The change from baseline at 12 months was estimated with a mixed model.
Secondary	Vision-related Quality of Life	12 months	Vision-related quality of life was measured by the vision targeted subscale (excluding general health) from the National Eye Institute Visual Functioning Questionnaire 25 item (VFQ-25). The VFQ-25 is a validated, participant reported measure of the aspects of visual functioning that are most important for persons who have chronic eye diseases. Higher scores indicate better vision. Scores range from 0 to 100. Meaningful difference is 4-6 points. Participants completed the VFQ-25 at baseline and months 3, 6 and 12. The outcome is the change in VFQ-25 from baseline to 12 months estimated with a mixed model.
Secondary	Cataract Surgery at 12 Months	12 months	Cumulative percent of uveitis eyes having cataract surgery by 12 months. Whether the patient had cataract surgery in the prior time period was determined at baseline and months 1,2,3,4,5,6,8,10,12 and the cumulative percent of eyes having cataract surgery by12 months was estimated by Kaplan-Meier methods.

Source ClinicalTrials.govtrials-2026-11-12-0.5.0

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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

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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.

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