Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis

Uveitis Clinical Trial

— PEACHTREE  

Official title:

A Phase 3, Randomized, Masked, Controlled Clinical Trial to Study the Safety and Efficacy of Triamcinolone Acetonide Injectable Suspension (CLS-TA) for the Treatment of Subjects With Macular Edema Associated With Non-infectious Uveitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02595398
• Other study ID #: CLS1001-301
• Status: Completed
• Phase: Phase 3
• 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
• 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.

Related Conditions & MeSH terms

• Macular Edema
• Panuveitis
• Uveitis
• Uveitis, Anterior
• Uveitis, Intermediate
• Uveitis, Posterior

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