Clinical Trial: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301

Study Status: Recruiting
Recruit Status: Recruiting
Study Type: Observational

Official Title: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis

Brief Summary: The purpose of this study is to characterize the continued clinical benefit(s) regarding safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide injectable suspension, for the treatment of macular edema associated with non-infectious uveitis. This study will be a non-interventional extension of the Parent study, CLS1001-301.

Detailed Summary:

This is a non-interventional extension study of up to 6 months for subjects completing the Parent study. The Parent study is a Phase 3, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.

The study design of the Extension study includes 4 clinic visits over a maximum of 24 weeks. Subject eligibility will be established at Visit 1 during the crossover day from the Parent study to the extension study (Day 0). Follow-up visits will be conducted every 6 weeks up to 24 weeks (Visit 4). At Visit 4, subjects will have a final evaluation conducted 24 weeks following study entry (48 weeks from Parent study randomization).

Sponsor: Clearside Biomedical, Inc.

Current Primary Outcome: Time to additional therapy for uveitis [ Time Frame: 6 months following exit from Parent study ]

Original Primary Outcome: Same as current

Current Secondary Outcome:

• Number of participants with treatment emergent adverse events and serious adverse events grouped by organ system, relatedness to study treatment and severity [ Time Frame: 6 months following exit from Parent study ]
  Grouped by organ system, relatedness to study treatment and severity
• Mean change from baseline in central subfield thickness [ Time Frame: 6 months following exit from Parent study ]
  Based on spectral domain optical coherence tomography
• Mean change from baseline in best corrected visual acuity [ Time Frame: 6 months following exit from Parent study ]
  Based on ETDRS

Original Secondary Outcome: Same as current

Information By: Clearside Biomedical, Inc.

Dates:
Date Received: October 31, 2016
Date Started: December 2016
Date Completion: September 2017
Last Updated: March 27, 2017
Last Verified: March 2017