Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis (PEACHTREE)
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|ClinicalTrials.gov Identifier: NCT02595398|
Recruitment Status : Completed
First Posted : November 3, 2015
Results First Posted : April 28, 2021
Last Update Posted : May 28, 2021
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|Condition or disease||Intervention/treatment||Phase|
|Uveitis Uveitis, Posterior Uveitis, Anterior Uveitis, Intermediate Panuveitis||Drug: 4mg CLS-TA Suprachoriodal Injection Drug: Sham Procedure||Phase 3|
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 :||Interventional (Clinical Trial)|
|Actual Enrollment :||160 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|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|
|Actual Study Start Date :||November 17, 2015|
|Actual Primary Completion Date :||January 18, 2018|
|Actual Study Completion Date :||January 18, 2018|
Experimental: 4mg CLS-TA Suprachoriodal Injection
Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
Drug: 4mg CLS-TA Suprachoriodal Injection
CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Other Name: Triamcinolone Acetonide
Sham Comparator: Sham Procedure
Matching suprachoroidal syringe with sham procedure
Drug: Sham Procedure
Sham procedure administered at 2 timepoints
Other Name: suprachoroidal sham
- Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks [ Time Frame: 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.
- Mean Change From Baseline in Central Subfield Thickness [ Time Frame: 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.
- Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [ Time Frame: 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.
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|Ages Eligible for Study:||18 Years and older (Adult, Older Adult)|
|Sexes Eligible for Study:||All|
|Accepts Healthy Volunteers:||No|
- 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
- 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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02595398
|Study Director:||Thomas Cuilla, MD, MBA||Clearside Biomedical, Inc.|
Documents provided by Clearside Biomedical, Inc.:
|Responsible Party:||Clearside Biomedical, Inc.|
|Other Study ID Numbers:||
|First Posted:||November 3, 2015 Key Record Dates|
|Results First Posted:||April 28, 2021|
|Last Update Posted:||May 28, 2021|
|Last Verified:||May 2021|
|Individual Participant Data (IPD) Sharing Statement:|
|Plan to Share IPD:||No|
|Studies a U.S. FDA-regulated Drug Product:||Yes|
|Studies a U.S. FDA-regulated Device Product:||No|
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