Registered outcomes11

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

1 to 11 of 11

List	Outcome	Time frame	Description
Primary	Change in grade of pain on an 11-point pain intensity numerical rating scale (NRS).	At the primary end point (week 16) and at the end of follow-up period (week 52) or at time of rescue	The proportion of subjects demonstrating improvement (mean change from BL) by 5 points in pain, graded on an 11-point pain intensity numerical rating scale (NRS).
Primary	Change in degree of inflammation, based on the standardized scleritis grading scale.	At the primary end point (week 16) and at the end of follow-up period (week 52) or at time of rescue	The proportion of subjects demonstrating improvement (mean change from BL) in inflammation (equal to or less than +0.5), based on the standardized scleritis grading scale.
Secondary	Best corrected visual acuity outcome	At week 16 (primary end point) and week 52 (end of follow-up) after therapy	Mean change from Baseline (BL) in BCVA by ≥ 10 letters or 2 lines using the ETDRS method and at week 16 and week 52 after therapy or at time of rescue.
Secondary	Vascular leakage outcome	At week 16 (primary end point) and week 52 (end of follow-up) after therapy	Changes in degree of leakage on fluorescein angiogram (as assessed by centralized reading center) of the optic nerve and/or retinal vasculature from Baseline (BL) through week 16 and week 52.
Secondary	Retinal thickness outcome	At week 16 (primary end point) and week 52 (end of follow-up) after therapy	Changes in retinal thickness as demonstrated by spectral-domain optical coherence tomography (OCT), as assessed by the centralized reading center, for subjects with macular edema from Baseline (BL) through week 16 and week 52.
Secondary	Scleral thickness outcome	At week 16 (primary end point) and week 52 (end of follow-up) after therapy	Changes in scleral thickness as demonstrated by spectral-domain optical coherence tomography (OCT), as assessed by the centralized reading center, from Baseline (BL) through week 16 and week 52.
Secondary	Dosage of systemic corticosteroids outcome	At week 16 (primary end point) and week 52 (end of follow-up) after therapy	Changes in the dosage of systemic corticosteroids from Baseline (BL) through week 16 and week 52.
Secondary	Response to therapy with/without systemic corticosteroids	At week 16 (primary end point) and week 52 (end of follow-up) after therapy	Proportion of subjects successfully weaned off of steroids by the primary end point.
Secondary	Changes in steroids dosage during study	At week 16 (primary end point) and week 52 (end of follow-up) after therapy	Mean change in the dose of steroids from BL to primary end point and from BL to week 52.
Other	Incidence and severity of ocular adverse events (AEs)	At Baseline (BL) and monthly visits after screening	The incidence and severity of ocular adverse events (AEs), as identified by eye examination (including BCVA testing), slit lamp biomicroscopy, optical coherence tomography OCT (anterior and posterior), anterior segment photography, fundus photography (FP) and fluorescein angiography (FA).
Other	Incidence and severity of other AEs	At Baseline (BL) and monthly visits after screening	The incidence and severity of other AEs, as identified by physical examinations, changes in vital signs, weight, clinical laboratory abnormalities, Electrocardiography (ECG) findings and subject reporting.

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

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.

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