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

Uveitis Clinical Trial

Official title:

MAGNOLIA: 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02952001
• Other study ID #: CLS1001-303
• Status: Completed
• Start date: December 13, 2017
• Est. completion date: May 22, 2018

Study information

• Verified date: May 2021
• Source: Clearside Biomedical, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

This study is a non-interventional, observational extension of the Parent study, CLS1001-301 (NCT02595398). 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.

Description:

This is a non-interventional, observation extension study of up to 6 months for subjects completing the Parent study, CLS1001-301 (NCT02595398). 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 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). This study was initiated prior to the completion of the parent study, therefore treatment assignment was masked prior to study entry.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: May 22, 2018
• Est. primary completion date: May 22, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Enrolled in the Parent study, CLS1001-301, through Visit 8/Month 6
• Willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits

Exclusion Criteria:

• Received additional therapy for the treatment of uveitis or prohibited medication
• Require additional therapy for the treatment of uveitis or prohibited medication at the time of the Crossover visit

Related Conditions & MeSH terms

• Panuveitis
• Uveitis
• Uveitis, Anterior
• Uveitis, Intermediate
• Uveitis, Posterior

Intervention

Drug:
• 4 mg CLS-TA Suprachoriodal Injection
This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.
• Sham procedure
This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.

Locations

Country	Name	City	State
India	Sankara Eye Hospital	Coimbatore	Tamil Nadu
India	Sri Sankaradeva Nethralaya	Guwahati	Assam
India	Disha Eye Hospitals Pvt. Ltd.	Kolkata
India	King George's Medical University	Lucknow	Uttar Pradesh
India	JSS Hospital	Mysore	Karnataka
India	Dr Rajendra Prasad Centre for Ophthalmic Sciences	New Delhi
United States	Valley Eye Physicians and Surgeons, PC	Ayer	Massachusetts
United States	Texas Retina Associates	Dallas	Texas
United States	Bergstrom Eye Research	Fargo	North Dakota
United States	Retina Group of Florida	Fort Lauderdale	Florida
United States	Marietta Eye Clinic	Marietta	Georgia
United States	Northern California Retina Vitreous Associates Medical Group, Inc.	Mountain View	California
United States	Retinal Consultants of Arizona	Phoenix	Arizona
United States	University of Pittsburgh Medical Center Eye Center	Pittsburgh	Pennsylvania
United States	Oregon Health & Science University Casey Eye Institute	Portland	Oregon
United States	Retina Consultants of Houston	The Woodlands	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Clearside Biomedical, Inc.

Countries where clinical trial is conducted

United States,  India, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time to Additional Therapy for Uveitis	This time to event outcome was calculated as the number of days between the date of initiation of additional therapy for uveitis and the date of first treatment in the Parent study CLS1001-301 (NCT02595398).	6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year
Secondary	Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events	Number of participants with treatment emergent adverse events and serious adverse events reported during the extension study.	6 months following exit from Parent study
Secondary	Mean Change From Baseline in Central Subfield Thickness	Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.	6 months following exit from Parent study
Secondary	Mean Change From Baseline in Best Corrected Visual Acuity	Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.	6 months following exit from Parent study