- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02595398
Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis (PEACHTREE)
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
Study Overview
Status
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
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Kolkata, India, 700027
- Calcutta Medical Research Institute
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Kolkata, India
- Disha Eye Hospital
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New Delhi, India, 110029
- Dr Rajendra Prasad Centre for Ophthalmic Sciences
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New Delhi, India
- Dr. Shroff's Charity Eye Hospital
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Andhra Pradesh
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Hyderabad, Andhra Pradesh, India
- L V Prasad Eye Hospital
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Assam
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Guwahati, Assam, India
- Sri Sankaradeva Nethralaya
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Gujarat
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Ahmedabad, Gujarat, India
- M&J Western Regional Institute of Ophthalmology
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Karnataka
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Mysore, Karnataka, India
- JSS Hospital
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Kerala
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Thiruvananthapuram, Kerala, India
- Regional Institute of Ophthalmology
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Maharashtra
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Mumbai, Maharashtra, India
- TN Medical College and BYL Nair Hospital
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Pune, Maharashtra, India
- PBMA's H V Desai Eye Hospital
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Tamil Nadu
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Chennai, Tamil Nadu, India
- Sankara Nethralaya
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Coimbatore, Tamil Nadu, India
- Sankara Eye Hospital
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Uttar Pradesh
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Lucknow, Uttar Pradesh, India
- King George's Medical University
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Lucknow, Uttar Pradesh, India
- Sanjay Gandhi Postgraduate Institute of Medical Sciences
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Noida, Uttar Pradesh, India
- Icare Eye Hospital & PG Institute
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Beer Sheva, Israel, 85025
- Soroka Medical Center
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Haifa, Israel, 3104802
- Bnai Zion Medical Center
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Haifa, Israel, 3109601
- Rambam Health Corp
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Jerusalem, Israel, 91120
- Hadassah-Hebrew University Medical Center
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Petah Tikva, Israel, 4941492
- Rabin Medical Center
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Ramat Gan, Israel, 52621
- Sheba Medical Center
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Rehovot, Israel, 76100
- Kaplan Medical Center
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Tel Aviv, Israel, 64239
- Tel-Aviv Sourasky Medical Center
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Arizona
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Phoenix, Arizona, United States, 85014
- Retinal Consultants of Arizona
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Tucson, Arizona, United States, 85704
- Retina Centers, PC
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California
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Bakersfield, California, United States, 93309
- California Retina Consultants
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Beverly Hills, California, United States, 90211
- Retina-Vitreous Associates Medical Group
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Los Angeles, California, United States, 90033
- USC Eye Institute
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Mountain View, California, United States, 94040
- Northern California Retina Vitreous Associates Medical Group, Inc.
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Santa Ana, California, United States, 92705
- Orange County Retina Medical Group
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Colorado
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Aurora, Colorado, United States, 80045
- University of Colorado
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Golden, Colorado, United States, 80401
- Colorado Retina Associates
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Florida
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Fort Lauderdale, Florida, United States, 33308
- Retina Group of Florida
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Lakeland, Florida, United States, 33805
- Center for Retina and Macular Disease
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Georgia
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Atlanta, Georgia, United States, 30322
- Emory Eye Center Emory University
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Marietta, Georgia, United States, 30060
- Marietta Eye Clinic
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Illinois
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Chicago, Illinois, United States, 60612
- University of Illinois at Chicago
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Chicago, Illinois, United States, 60611
- Northwestern University
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Oak Park, Illinois, United States, 60304
- Illinois Retina Associates, S.C.
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Indiana
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Indianapolis, Indiana, United States, 46290
- Midwest Eye Retina Practicing at Midwest Eye Institute
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Maryland
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Baltimore, Maryland, United States, 21237
- Elman Retina Group, PA
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Chevy Chase, Maryland, United States, 20815
- The Retina Group of Washington
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Massachusetts
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Ayer, Massachusetts, United States, 01432
- Valley Eye Physicians and Surgeons, PC
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Boston, Massachusetts, United States, 02114
- Ophthalmic Consultants of Boston
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Waltham, Massachusetts, United States, 01741
- Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution
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Missouri
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Independence, Missouri, United States, 64055
- Discover Vision Centers
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New Jersey
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Palisades Park, New Jersey, United States, 07650
- Metropolitan Eye Research & Surgery Institute
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New York
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New York, New York, United States, 10021
- Weill Cornell Medical College
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Slingerlands, New York, United States, 12159
- Retina Consultants PLLC
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North Carolina
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Belmont, North Carolina, United States, 28012
- Charlotte Eye Ear Nose and Throat Associates, PA
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Winston-Salem, North Carolina, United States, 27103
- Wake Forest Baptist Health Eye Center
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North Dakota
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Fargo, North Dakota, United States, 58103
- Bergstrom Eye Research
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Oregon
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Portland, Oregon, United States, 97239
- Oregon Health & Science University Casey Eye Institute
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Pennsylvania
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Philadelphia, Pennsylvania, United States, 19107
- Mid Atlantic Retina
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Pittsburgh, Pennsylvania, United States, 15213
- University of Pittsburgh Medical Center Eye Center
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South Carolina
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Greenville, South Carolina, United States, 29605
- Innovative Clinical Research
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Texas
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Austin, Texas, United States, 78705
- Austin Retina Associates
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Dallas, Texas, United States, 75231
- Texas Retina Associates
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Houston, Texas, United States, 77030
- Retina Consultants of Houston
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San Antonio, Texas, United States, 78233
- Foresight Studies, LLC
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The Woodlands, Texas, United States, 77384
- Retina Consultants of Houston
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Virginia
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Norfolk, Virginia, United States, 23502
- Virginia Eye Consultants
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Washington
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Bellevue, Washington, United States, 98004
- Vitreoretinal Associates of Washington
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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 Plan
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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EXPERIMENTAL: 4mg CLS-TA Suprachoriodal Injection
Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
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CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Other Names:
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SHAM_COMPARATOR: Sham Procedure
Matching suprachoroidal syringe with sham procedure
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Sham procedure administered at 2 timepoints
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
Time Frame: Baseline, 24 weeks
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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.
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Baseline, 24 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Mean Change From Baseline in Central Subfield Thickness
Time Frame: Baseline, 24 weeks
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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.
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Baseline, 24 weeks
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Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Time Frame: Baseline to 24 weeks
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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.
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Baseline to 24 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: Thomas Cuilla, MD, MBA, Clearside Biomedical, Inc.
Publications and helpful links
General Publications
- Yeh S, Henry CR, Kapik B, Ciulla TA. Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies. Ophthalmol Ther. 2022 Nov 18. doi: 10.1007/s40123-022-00603-x. Online ahead of print.
- Bhattacharyya S, Hariprasad SM, Albini TA, Dutta SK, John D, Padula WV, Harrison D, Joseph G. Suprachoroidal Injection of Triamcinolone Acetonide Injectable Suspension for the Treatment of Macular Edema Associated With Uveitis in the United States: A Cost-Effectiveness Analysis. Value Health. 2022 Oct;25(10):1705-1716. doi: 10.1016/j.jval.2022.07.008. Epub 2022 Aug 31.
- Singer MA, Merrill P, Yeh S, Hall C, Kapik B, Ciulla TA. Suprachoroidal triamcinolone acetonide versus rescue therapies for the treatment of uveitic macular oedema: A post hoc analysis of PEACHTREE. Clin Exp Ophthalmol. 2022 Jan;50(1):23-30. doi: 10.1111/ceo.14024. Epub 2021 Dec 27.
- Price KW, Albini TA, Yeh S. Suprachoroidal Injection of Triamcinolone- Review of a Novel Treatment for Macular Edema Caused by Noninfectious Uveitis. US Ophthalmic Rev. 2020 Fall;13(2):76-79. doi: 10.17925/usor.2020.13.2.76. Epub 2020 Dec 23.
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ESTIMATE)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Eye Diseases
- Retinal Degeneration
- Retinal Diseases
- Uveal Diseases
- Choroid Diseases
- Macular Degeneration
- Choroiditis
- Macular Edema
- Uveitis
- Uveitis, Posterior
- Panuveitis
- Uveitis, Intermediate
- Pars Planitis
- Uveitis, Anterior
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Anti-Inflammatory Agents
- Immunosuppressive Agents
- Immunologic Factors
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Triamcinolone
- Triamcinolone Acetonide
- Triamcinolone hexacetonide
- Triamcinolone diacetate
Other Study ID Numbers
- CLS1001-301
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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