ZILRETTA in Subjects With Shoulder Osteoarthritis

Inclusion criteria

• ✓. Written informed consent has been obtained prior to initiating any study-specific procedures.
• ✓. Willingness and ability to comply with the study procedures and visit schedules and ability to follow verbal and written instructions, including eDiary questionnaire completion requirements.
• ✓. Participants 50 to 80 years of age, inclusive, on the day of consent.
• ✓. Body mass index (BMI) does not prohibit proper identification of bony landmarks and/or otherwise prohibit the ability to properly inject into the shoulder joint per Principal Investigator's (PI's) judgment.
• ✓. Participants with shoulder pain and glenohumeral arthritis with or without rotator cuff pathology (eg, rotator cuff inflammation, partial rotator cuff tear \[non-to-mild superior subluxation of the humeral head on X-ray\] may be included). Participants with positive Neer and Hawkins-Kennedy tests on index shoulder exam should be excluded. Participants who have complete or irreparable rotator cuff tear should not be included.
• ✓. Grade 1, 2, or 3 OA in the index glenohumeral joint based on the Samilson-Prieto classification system as confirmed by X-ray (axillary view and true anterior-posterior view) taken at, or within 6 months of, the Screening Visit and read by the central reader.
• ✓. Average daily mean pain score ≥4.0 and ≤9.0 in index shoulder (0-10 numeric rating scale \[NRS\]) using the average daily ratings for at least 4 out of the 7 days prior to Baseline/Day 1.
• ✓. Average Shoulder Pain and Disability Index (SPADI) pain score ≥4.0 and ≤9.0 in index shoulder during the Screening and Pretreatment Phase (average score) as calculated and reported in the electronic Clinical Outcomes Assessment (eCOA).

Exclusion criteria