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
1 other identifier
interventional
160
3 countries
64
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Nov 2015
64 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 28, 2015
CompletedFirst Posted
Study publicly available on registry
November 3, 2015
CompletedStudy Start
First participant enrolled
November 17, 2015
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 18, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
January 18, 2018
CompletedResults Posted
Study results publicly available
April 28, 2021
CompletedMay 28, 2021
May 1, 2021
2.2 years
October 28, 2015
April 2, 2021
May 4, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (2)
Mean Change From Baseline in Central Subfield Thickness
Baseline, 24 weeks
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Baseline to 24 weeks
Study Arms (2)
4mg CLS-TA Suprachoriodal Injection
EXPERIMENTALSuprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
Sham Procedure
SHAM COMPARATORMatching suprachoroidal syringe with sham procedure
Interventions
CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Sham procedure administered at 2 timepoints
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (64)
Retinal Consultants of Arizona
Phoenix, Arizona, 85014, United States
Retina Centers, PC
Tucson, Arizona, 85704, United States
California Retina Consultants
Bakersfield, California, 93309, United States
Retina-Vitreous Associates Medical Group
Beverly Hills, California, 90211, United States
USC Eye Institute
Los Angeles, California, 90033, United States
Northern California Retina Vitreous Associates Medical Group, Inc.
Mountain View, California, 94040, United States
Orange County Retina Medical Group
Santa Ana, California, 92705, United States
University of Colorado
Aurora, Colorado, 80045, United States
Colorado Retina Associates
Golden, Colorado, 80401, United States
Retina Group of Florida
Fort Lauderdale, Florida, 33308, United States
Center for Retina and Macular Disease
Lakeland, Florida, 33805, United States
Emory Eye Center Emory University
Atlanta, Georgia, 30322, United States
Marietta Eye Clinic
Marietta, Georgia, 30060, United States
Northwestern University
Chicago, Illinois, 60611, United States
University of Illinois at Chicago
Chicago, Illinois, 60612, United States
Illinois Retina Associates, S.C.
Oak Park, Illinois, 60304, United States
Midwest Eye Retina Practicing at Midwest Eye Institute
Indianapolis, Indiana, 46290, United States
Elman Retina Group, PA
Baltimore, Maryland, 21237, United States
The Retina Group of Washington
Chevy Chase, Maryland, 20815, United States
Valley Eye Physicians and Surgeons, PC
Ayer, Massachusetts, 01432, United States
Ophthalmic Consultants of Boston
Boston, Massachusetts, 02114, United States
Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution
Waltham, Massachusetts, 01741, United States
Discover Vision Centers
Independence, Missouri, 64055, United States
Metropolitan Eye Research & Surgery Institute
Palisades Park, New Jersey, 07650, United States
Weill Cornell Medical College
New York, New York, 10021, United States
Retina Consultants PLLC
Slingerlands, New York, 12159, United States
Charlotte Eye Ear Nose and Throat Associates, PA
Belmont, North Carolina, 28012, United States
Wake Forest Baptist Health Eye Center
Winston-Salem, North Carolina, 27103, United States
Bergstrom Eye Research
Fargo, North Dakota, 58103, United States
Oregon Health & Science University Casey Eye Institute
Portland, Oregon, 97239, United States
Mid Atlantic Retina
Philadelphia, Pennsylvania, 19107, United States
University of Pittsburgh Medical Center Eye Center
Pittsburgh, Pennsylvania, 15213, United States
Innovative Clinical Research
Greenville, South Carolina, 29605, United States
Austin Retina Associates
Austin, Texas, 78705, United States
Texas Retina Associates
Dallas, Texas, 75231, United States
Retina Consultants of Houston
Houston, Texas, 77030, United States
Foresight Studies, LLC
San Antonio, Texas, 78233, United States
Retina Consultants of Houston
The Woodlands, Texas, 77384, United States
Virginia Eye Consultants
Norfolk, Virginia, 23502, United States
Vitreoretinal Associates of Washington
Bellevue, Washington, 98004, United States
L V Prasad Eye Hospital
Hyderabad, Andhra Pradesh, India
Sri Sankaradeva Nethralaya
Guwahati, Assam, India
M&J Western Regional Institute of Ophthalmology
Ahmedabad, Gujarat, India
JSS Hospital
Mysore, Karnataka, India
Regional Institute of Ophthalmology
Thiruvananthapuram, Kerala, India
TN Medical College and BYL Nair Hospital
Mumbai, Maharashtra, India
PBMA's H V Desai Eye Hospital
Pune, Maharashtra, India
Sankara Nethralaya
Chennai, Tamil Nadu, India
Sankara Eye Hospital
Coimbatore, Tamil Nadu, India
King George's Medical University
Lucknow, Uttar Pradesh, India
Sanjay Gandhi Postgraduate Institute of Medical Sciences
Lucknow, Uttar Pradesh, India
Icare Eye Hospital & PG Institute
Noida, Uttar Pradesh, India
Calcutta Medical Research Institute
Kolkata, 700027, India
Disha Eye Hospital
Kolkata, India
Dr Rajendra Prasad Centre for Ophthalmic Sciences
New Delhi, 110029, India
Dr. Shroff's Charity Eye Hospital
New Delhi, India
Soroka Medical Center
Beersheba, 85025, Israel
Bnai Zion Medical Center
Haifa, 3104802, Israel
Rambam Health Corp
Haifa, 3109601, Israel
Hadassah-Hebrew University Medical Center
Jerusalem, 91120, Israel
Rabin Medical Center
Petah Tikva, 4941492, Israel
Sheba Medical Center
Ramat Gan, 52621, Israel
Kaplan Medical Center
Rehovot, 76100, Israel
Tel-Aviv Sourasky Medical Center
Tel Aviv, 64239, Israel
Related Publications (5)
Yeh S, Ciulla T. Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety. Am J Manag Care. 2023 Feb;29(2 Suppl):S19-S28. doi: 10.37765/ajmc.2023.89324.
PMID: 36787524DERIVEDYeh 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. 2023 Feb;12(1):577-591. doi: 10.1007/s40123-022-00603-x. Epub 2022 Nov 18.
PMID: 36399237DERIVEDBhattacharyya 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.
PMID: 36055922DERIVEDSinger 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.
PMID: 34741564DERIVEDPrice 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.
PMID: 34322164DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Thomas Ciulla, MD MBA
- Organization
- Clearside Biomedical, Inc.
Study Officials
- STUDY DIRECTOR
Thomas Cuilla, MD, MBA
Clearside Biomedical, Inc.
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 28, 2015
First Posted
November 3, 2015
Study Start
November 17, 2015
Primary Completion
January 18, 2018
Study Completion
January 18, 2018
Last Updated
May 28, 2021
Results First Posted
April 28, 2021
Record last verified: 2021-05
Data Sharing
- IPD Sharing
- Will not share