Immunosuppresants comparison for UVEITIS

Phase 3

Completed

• Conditions: Health Condition 1: null- Non Infectious Uveitis

• Registration Number: CTRI/2017/09/009699
• Lead Sponsor: Proctor Foundation University of California

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2018-08-31
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 130

Inclusion Criteria

1) Historical non-infectious intermediate, anterior and intermediate, posterior or panuveitis in at least one eye

2) Active inflammation within the last 180 days, defined by the presence of any of the following (in at least one eye) according to SUN criteria:

a) >= 2+ anterior chamber cells

b) >= 2+ vitreous haze

c) active retinal or choroidal lesions

3) Active inflammation at enrollment, defined by the presence of any of the following (in at least one eye) according to SUN criteria:

a) >=1+ anterior chamber cells and/or

b) >=1+ vitreous haze and/or

c) active retinal/choroidal lesions

Exclusion Criteria

1) Any infectious cause of uveitis

2) Prior immunosuppressive therapy other than corticosteroids in the past 12 months

3) Prior intolerability or safety issues with methotrexate or mycophenolate mofetil

4) Prior failure to control ocular or other inflammation using methotrexate or mycophenolate mofetil

5) Prior biologic therapy at any time

6) Media opacity (such as cataract and/or corneal scar) and/or extensive posterior synechiae such that examination of the posterior segment is not possible in both eyes

7) Chronic hypotony (IOP < 5 mm Hg for > 3 months) in both eyes

8) Periocular or intravitreal corticosteroid injection in the past 4 weeks

9) Fluocinolone acetonide implant in either eye in < 3 years

10) Intraocular surgery in < 30 days, or planning on getting surgery within the next 6 months

11) Best spectacle-corrected visual acuity (BSCVA) of hand motions or worse in better eye

< 16 years of age at enrollment

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Treatment Success of <br/ ><br>Controlled ocular inflammation (â?¤ 0.5+ anterior chamber cells, â?¤ 0.5+ vitreous haze, no active retinal/choroidal lesions in both eyes) with 7.5 mg/day of oral prednisone and â?¤ 2 drops/day of topical 1% prednisolone acetateTimepoint: 6 months

Secondary Outcome Measures

Name	Time	Method
Change in visual acuity Macular edema <br/ ><br>Time to control of inflammation <br/ ><br>Changes in quality of life Adverse event rateTimepoint: 6 months