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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02952001
Other study ID # CLS1001-303
Secondary ID
Status Completed
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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