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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02595398
Other study ID # CLS1001-301
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
Start date November 17, 2015
Est. completion date January 18, 2018

Study information

Verified date May 2021
Source Clearside Biomedical, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.


Description:

This is a Phase 3, randomized, masked, sham-controlled, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham injection procedure in the treatment of subjects with macular edema associated with non-infectious uveitis. Qualified subjects will be randomized to receive two suprachoroidal injections of CLS-TA administered to the study eye or two sham injection procedures administered to the study eye approximately 12 weeks apart (Visit 2 and Visit 5). Follow-up visits will be conducted monthly up to 24 weeks (Visit 8).


Recruitment information / eligibility

Status Completed
Enrollment 160
Est. completion date January 18, 2018
Est. primary completion date January 18, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: - Diagnosis of non-infectious uveitis (pan, anterior, intermediate and posterior) - Diagnosis of macular edema associated with non-infectious uveitis (retinal thickness = 300 microns) - Visual Acuity score of = 5 letters read (20/800 Snellen equivalent) and = 70 letters read (20/40 Snellen equivalent), in the study eye Exclusion Criteria: - Any active ocular disease or infection in the study eye other than uveitis - Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; subjects are not excluded if IOP = 22 mmHg with no more than 2 IOP lowering medications. - Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study - Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.

Study Design


Intervention

Drug:
4mg CLS-TA Suprachoriodal Injection
CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Sham Procedure
Sham procedure administered at 2 timepoints

Locations

Country Name City State
India M&J Western Regional Institute of Ophthalmology Ahmedabad Gujarat
India Sankara Nethralaya Chennai Tamil Nadu
India Sankara Eye Hospital Coimbatore Tamil Nadu
India Sri Sankaradeva Nethralaya Guwahati Assam
India L V Prasad Eye Hospital Hyderabad Andhra Pradesh
India Calcutta Medical Research Institute Kolkata
India Disha Eye Hospital Kolkata
India King George's Medical University Lucknow Uttar Pradesh
India Sanjay Gandhi Postgraduate Institute of Medical Sciences Lucknow Uttar Pradesh
India TN Medical College and BYL Nair Hospital Mumbai Maharashtra
India JSS Hospital Mysore Karnataka
India Dr Rajendra Prasad Centre for Ophthalmic Sciences New Delhi
India Dr. Shroff's Charity Eye Hospital New Delhi
India Icare Eye Hospital & PG Institute Noida Uttar Pradesh
India PBMA's H V Desai Eye Hospital Pune Maharashtra
India Regional Institute of Ophthalmology Thiruvananthapuram Kerala
Israel Soroka Medical Center Beer Sheva
Israel Bnai Zion Medical Center Haifa
Israel Rambam Health Corp Haifa
Israel Hadassah-Hebrew University Medical Center Jerusalem
Israel Rabin Medical Center Petah Tikva
Israel Sheba Medical Center Ramat Gan
Israel Kaplan Medical Center Rehovot
Israel Tel-Aviv Sourasky Medical Center Tel Aviv
United States Emory Eye Center Emory University Atlanta Georgia
United States University of Colorado Aurora Colorado
United States Austin Retina Associates Austin Texas
United States Valley Eye Physicians and Surgeons, PC Ayer Massachusetts
United States California Retina Consultants Bakersfield California
United States Elman Retina Group, PA Baltimore Maryland
United States Vitreoretinal Associates of Washington Bellevue Washington
United States Charlotte Eye Ear Nose and Throat Associates, PA Belmont North Carolina
United States Retina-Vitreous Associates Medical Group Beverly Hills California
United States Ophthalmic Consultants of Boston Boston Massachusetts
United States The Retina Group of Washington Chevy Chase Maryland
United States Northwestern University Chicago Illinois
United States University of Illinois at Chicago Chicago Illinois
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 Colorado Retina Associates Golden Colorado
United States Innovative Clinical Research Greenville South Carolina
United States Retina Consultants of Houston Houston Texas
United States Discover Vision Centers Independence Missouri
United States Midwest Eye Retina Practicing at Midwest Eye Institute Indianapolis Indiana
United States Center for Retina and Macular Disease Lakeland Florida
United States USC Eye Institute Los Angeles California
United States Marietta Eye Clinic Marietta Georgia
United States Northern California Retina Vitreous Associates Medical Group, Inc. Mountain View California
United States Weill Cornell Medical College New York New York
United States Virginia Eye Consultants Norfolk Virginia
United States Illinois Retina Associates, S.C. Oak Park Illinois
United States Metropolitan Eye Research & Surgery Institute Palisades Park New Jersey
United States Mid Atlantic Retina Philadelphia Pennsylvania
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 Foresight Studies, LLC San Antonio Texas
United States Orange County Retina Medical Group Santa Ana California
United States Retina Consultants PLLC Slingerlands New York
United States Retina Consultants of Houston The Woodlands Texas
United States Retina Centers, PC Tucson Arizona
United States Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution Waltham Massachusetts
United States Wake Forest Baptist Health Eye Center Winston-Salem North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Clearside Biomedical, Inc.

Countries where clinical trial is conducted

United States,  India,  Israel, 

Outcome

Type Measure Description Time frame Safety issue
Primary Number of Subjects Demonstrating = 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks 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 electronic Visual Acuity (eVA). An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement. Baseline, 24 weeks
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. Only images that were gradable by the central reading center were included in the analysis. Baseline, 24 weeks
Secondary Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) Number of subjects with treatment-emergent adverse events (TEAEs) and serious adverse events (SAEs) reported between the first dose of study drug and study exit. Baseline to 24 weeks
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