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

Phase 3

Completed

• Conditions: Uveitis; Uveitis, Posterior; Uveitis, Anterior; Uveitis, Intermediate; Panuveitis
• Interventions: Drug: Sham Procedure; Drug: 4mg CLS-TA Suprachoriodal Injection

• Registration Number: NCT02595398
• Lead Sponsor: Clearside Biomedical, Inc.

Brief 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.

Detailed 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).

Study Timeline

• Study First Submitted: 2015-10-28
• Study First Submitted QC: 2015-11-02
• Study First Posted: 2015-11-03
• Study Start: 2015-11-17
• Primary Completion: 2018-01-18
• Study Completion: 2018-01-18
• Disposition First Submitted: 2018-09-13
• Disposition First Submitted QC: 2018-09-13
• Disposition First Posted: 2018-09-18
• Results First Submitted: 2021-04-02
• Results First Submitted QC: 2021-04-02
• Results First Posted: 2021-04-28
• Status Verified: 2021-05
• Last Update Submitted: 2021-05-04
• Last Update Posted: 2021-05-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 160

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Sham Procedure	Sham Procedure	Matching suprachoroidal syringe with sham procedure
4mg CLS-TA Suprachoriodal Injection	4mg CLS-TA Suprachoriodal Injection	Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA

Primary Outcome Measures

Name	Time	Method
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks	Baseline, 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.

Secondary Outcome Measures

Name	Time	Method
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)	Baseline to 24 weeks	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.
Mean Change From Baseline in Central Subfield Thickness	Baseline, 24 weeks	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.

Trial Locations

Locations (63)

Emory Eye Center Emory University; 🇺🇸 Atlanta, Georgia, United States

University of Illinois at Chicago; 🇺🇸 Chicago, Illinois, United States

Elman Retina Group, PA; 🇺🇸 Baltimore, Maryland, United States

Retina Group of Florida; 🇺🇸 Fort Lauderdale, Florida, United States

Retinal Consultants of Arizona; 🇺🇸 Phoenix, Arizona, United States

Marietta Eye Clinic; 🇺🇸 Marietta, Georgia, United States

Retina Consultants PLLC; 🇺🇸 Slingerlands, New York, United States

Colorado Retina Associates; 🇺🇸 Golden, Colorado, United States

Ophthalmic Consultants of Boston; 🇺🇸 Boston, Massachusetts, United States

University of Pittsburgh Medical Center Eye Center; 🇺🇸 Pittsburgh, Pennsylvania, United States

Vitreoretinal Associates of Washington; 🇺🇸 Bellevue, Washington, United States

Center for Retina and Macular Disease; 🇺🇸 Lakeland, Florida, United States

Retina-Vitreous Associates Medical Group; 🇺🇸 Beverly Hills, California, United States

Northwestern University; 🇺🇸 Chicago, Illinois, United States

Retina Consultants of Houston; 🇺🇸 The Woodlands, Texas, United States

Sankara Nethralaya; 🇮🇳 Chennai, Tamil Nadu, India

Weill Cornell Medical College; 🇺🇸 New York, New York, United States

Dr. Shroff's Charity Eye Hospital; 🇮🇳 New Delhi, India

Sheba Medical Center; 🇮🇱 Ramat Gan, Israel

Oregon Health & Science University Casey Eye Institute; 🇺🇸 Portland, Oregon, United States

King George's Medical University; 🇮🇳 Lucknow, Uttar Pradesh, India

Sankara Eye Hospital; 🇮🇳 Coimbatore, Tamil Nadu, India

Retina Centers, PC; 🇺🇸 Tucson, Arizona, United States

California Retina Consultants; 🇺🇸 Bakersfield, California, United States

USC Eye Institute; 🇺🇸 Los Angeles, California, United States

Northern California Retina Vitreous Associates Medical Group, Inc.; 🇺🇸 Mountain View, California, United States

Orange County Retina Medical Group; 🇺🇸 Santa Ana, California, United States

Midwest Eye Retina Practicing at Midwest Eye Institute; 🇺🇸 Indianapolis, Indiana, United States

The Retina Group of Washington; 🇺🇸 Chevy Chase, Maryland, United States

Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution; 🇺🇸 Waltham, Massachusetts, United States

Discover Vision Centers; 🇺🇸 Independence, Missouri, United States

Bergstrom Eye Research; 🇺🇸 Fargo, North Dakota, United States

Innovative Clinical Research; 🇺🇸 Greenville, South Carolina, United States

Austin Retina Associates; 🇺🇸 Austin, Texas, United States

Texas Retina Associates; 🇺🇸 Dallas, Texas, United States

Foresight Studies, LLC; 🇺🇸 San Antonio, Texas, United States

Virginia Eye Consultants; 🇺🇸 Norfolk, Virginia, United States

Regional Institute of Ophthalmology; 🇮🇳 Thiruvananthapuram, Kerala, India

Mid Atlantic Retina; 🇺🇸 Philadelphia, Pennsylvania, United States

Charlotte Eye Ear Nose and Throat Associates, PA; 🇺🇸 Belmont, North Carolina, United States

University of Colorado; 🇺🇸 Aurora, Colorado, United States

Wake Forest Baptist Health Eye Center; 🇺🇸 Winston-Salem, North Carolina, United States

L V Prasad Eye Hospital; 🇮🇳 Hyderabad, Andhra Pradesh, India

Metropolitan Eye Research & Surgery Institute; 🇺🇸 Palisades Park, New Jersey, United States

Sri Sankaradeva Nethralaya; 🇮🇳 Guwahati, Assam, India

JSS Hospital; 🇮🇳 Mysore, Karnataka, India

Kaplan Medical Center; 🇮🇱 Rehovot, Israel

Icare Eye Hospital & PG Institute; 🇮🇳 Noida, Uttar Pradesh, India

Rambam Health Corp; 🇮🇱 Haifa, Israel

Hadassah-Hebrew University Medical Center; 🇮🇱 Jerusalem, Israel

TN Medical College and BYL Nair Hospital; 🇮🇳 Mumbai, Maharashtra, India

PBMA's H V Desai Eye Hospital; 🇮🇳 Pune, Maharashtra, India

Calcutta Medical Research Institute; 🇮🇳 Kolkata, India

Disha Eye Hospital; 🇮🇳 Kolkata, India

Dr Rajendra Prasad Centre for Ophthalmic Sciences; 🇮🇳 New Delhi, India

Soroka Medical Center; 🇮🇱 Beer Sheva, Israel

Bnai Zion Medical Center; 🇮🇱 Haifa, Israel

Rabin Medical Center; 🇮🇱 Petah Tikva, Israel

Tel-Aviv Sourasky Medical Center; 🇮🇱 Tel Aviv, Israel

Illinois Retina Associates, S.C.; 🇺🇸 Oak Park, Illinois, United States

M&J Western Regional Institute of Ophthalmology; 🇮🇳 Ahmedabad, Gujarat, India

Sanjay Gandhi Postgraduate Institute of Medical Sciences; 🇮🇳 Lucknow, Uttar Pradesh, India

Valley Eye Physicians and Surgeons, PC; 🇺🇸 Ayer, Massachusetts, United States