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

Primary Purpose

Uveitis, Uveitis, Posterior, Uveitis, Anterior

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
4mg CLS-TA Suprachoriodal Injection
Sham Procedure
Sponsored by
Clearside Biomedical, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Uveitis focused on measuring Uveitis, UME, Posterior Uveitis, Anterior Uveitis, Intermediate Uveitis, Panuveitis, Non-infectious Uveitis, Triamcinolone, Choroid, Choroidal Injection, Suprachoroidal, Microneedle, Microinjection, Triamcinolone acetonide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Retinal Consultants of Arizona
  • Retina Centers, PC
  • California Retina Consultants
  • Retina-Vitreous Associates Medical Group
  • USC Eye Institute
  • Northern California Retina Vitreous Associates Medical Group, Inc.
  • Orange County Retina Medical Group
  • University of Colorado
  • Colorado Retina Associates
  • Retina Group of Florida
  • Center for Retina and Macular Disease
  • Emory Eye Center Emory University
  • Marietta Eye Clinic
  • Northwestern University
  • University of Illinois at Chicago
  • Illinois Retina Associates, S.C.
  • Midwest Eye Retina Practicing at Midwest Eye Institute
  • Elman Retina Group, PA
  • The Retina Group of Washington
  • Valley Eye Physicians and Surgeons, PC
  • Ophthalmic Consultants of Boston
  • Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution
  • Discover Vision Centers
  • Metropolitan Eye Research & Surgery Institute
  • Weill Cornell Medical College
  • Retina Consultants PLLC
  • Charlotte Eye Ear Nose and Throat Associates, PA
  • Wake Forest Baptist Health Eye Center
  • Bergstrom Eye Research
  • Oregon Health & Science University Casey Eye Institute
  • Mid Atlantic Retina
  • University of Pittsburgh Medical Center Eye Center
  • Innovative Clinical Research
  • Austin Retina Associates
  • Texas Retina Associates
  • Retina Consultants of Houston
  • Foresight Studies, LLC
  • Retina Consultants of Houston
  • Virginia Eye Consultants
  • Vitreoretinal Associates of Washington
  • L V Prasad Eye Hospital
  • Sri Sankaradeva Nethralaya
  • M&J Western Regional Institute of Ophthalmology
  • JSS Hospital
  • Regional Institute of Ophthalmology
  • TN Medical College and BYL Nair Hospital
  • PBMA's H V Desai Eye Hospital
  • Sankara Nethralaya
  • Sankara Eye Hospital
  • King George's Medical University
  • Sanjay Gandhi Postgraduate Institute of Medical Sciences
  • Icare Eye Hospital & PG Institute
  • Calcutta Medical Research Institute
  • Disha Eye Hospital
  • Dr Rajendra Prasad Centre for Ophthalmic Sciences
  • Dr. Shroff's Charity Eye Hospital
  • Soroka Medical Center
  • Bnai Zion Medical Center
  • Rambam Health Corp
  • Hadassah-Hebrew University Medical Center
  • Rabin Medical Center
  • Sheba Medical Center
  • Kaplan Medical Center
  • Tel-Aviv Sourasky Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Sham Comparator

Arm Label

4mg CLS-TA Suprachoriodal Injection

Sham Procedure

Arm Description

Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA

Matching suprachoroidal syringe with sham procedure

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.
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.

Full Information

First Posted
October 28, 2015
Last Updated
May 4, 2021
Sponsor
Clearside Biomedical, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT02595398
Brief Title
Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2021
Overall Recruitment Status
Completed
Study Start Date
November 17, 2015 (Actual)
Primary Completion Date
January 18, 2018 (Actual)
Study Completion Date
January 18, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Clearside Biomedical, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Uveitis, Posterior, Uveitis, Anterior, Uveitis, Intermediate, Panuveitis
Keywords
Uveitis, UME, Posterior Uveitis, Anterior Uveitis, Intermediate Uveitis, Panuveitis, Non-infectious Uveitis, Triamcinolone, Choroid, Choroidal Injection, Suprachoroidal, Microneedle, Microinjection, Triamcinolone acetonide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
160 (Actual)

8. Arms, Groups, and Interventions

Arm Title
4mg CLS-TA Suprachoriodal Injection
Arm Type
Experimental
Arm Description
Suprachoroidal injection of 40 mg/mL (4 mg in 100 µL) of CLS-TA
Arm Title
Sham Procedure
Arm Type
Sham Comparator
Arm Description
Matching suprachoroidal syringe with sham procedure
Intervention Type
Drug
Intervention Name(s)
4mg CLS-TA Suprachoriodal Injection
Other Intervention Name(s)
Triamcinolone Acetonide
Intervention Description
CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints
Intervention Type
Drug
Intervention Name(s)
Sham Procedure
Other Intervention Name(s)
suprachoroidal sham
Intervention Description
Sham procedure administered at 2 timepoints
Primary Outcome Measure Information:
Title
Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
Description
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.
Time Frame
Baseline, 24 weeks
Secondary Outcome Measure Information:
Title
Mean Change From Baseline in Central Subfield Thickness
Description
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.
Time Frame
Baseline, 24 weeks
Title
Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
Description
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.
Time Frame
Baseline to 24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Cuilla, MD, MBA
Organizational Affiliation
Clearside Biomedical, Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Retinal Consultants of Arizona
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Retina Centers, PC
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85704
Country
United States
Facility Name
California Retina Consultants
City
Bakersfield
State/Province
California
ZIP/Postal Code
93309
Country
United States
Facility Name
Retina-Vitreous Associates Medical Group
City
Beverly Hills
State/Province
California
ZIP/Postal Code
90211
Country
United States
Facility Name
USC Eye Institute
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
Northern California Retina Vitreous Associates Medical Group, Inc.
City
Mountain View
State/Province
California
ZIP/Postal Code
94040
Country
United States
Facility Name
Orange County Retina Medical Group
City
Santa Ana
State/Province
California
ZIP/Postal Code
92705
Country
United States
Facility Name
University of Colorado
City
Aurora
State/Province
Colorado
ZIP/Postal Code
80045
Country
United States
Facility Name
Colorado Retina Associates
City
Golden
State/Province
Colorado
ZIP/Postal Code
80401
Country
United States
Facility Name
Retina Group of Florida
City
Fort Lauderdale
State/Province
Florida
ZIP/Postal Code
33308
Country
United States
Facility Name
Center for Retina and Macular Disease
City
Lakeland
State/Province
Florida
ZIP/Postal Code
33805
Country
United States
Facility Name
Emory Eye Center Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Marietta Eye Clinic
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
University of Illinois at Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
Illinois Retina Associates, S.C.
City
Oak Park
State/Province
Illinois
ZIP/Postal Code
60304
Country
United States
Facility Name
Midwest Eye Retina Practicing at Midwest Eye Institute
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46290
Country
United States
Facility Name
Elman Retina Group, PA
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21237
Country
United States
Facility Name
The Retina Group of Washington
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Valley Eye Physicians and Surgeons, PC
City
Ayer
State/Province
Massachusetts
ZIP/Postal Code
01432
Country
United States
Facility Name
Ophthalmic Consultants of Boston
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
01741
Country
United States
Facility Name
Discover Vision Centers
City
Independence
State/Province
Missouri
ZIP/Postal Code
64055
Country
United States
Facility Name
Metropolitan Eye Research & Surgery Institute
City
Palisades Park
State/Province
New Jersey
ZIP/Postal Code
07650
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10021
Country
United States
Facility Name
Retina Consultants PLLC
City
Slingerlands
State/Province
New York
ZIP/Postal Code
12159
Country
United States
Facility Name
Charlotte Eye Ear Nose and Throat Associates, PA
City
Belmont
State/Province
North Carolina
ZIP/Postal Code
28012
Country
United States
Facility Name
Wake Forest Baptist Health Eye Center
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Bergstrom Eye Research
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58103
Country
United States
Facility Name
Oregon Health & Science University Casey Eye Institute
City
Portland
State/Province
Oregon
ZIP/Postal Code
97239
Country
United States
Facility Name
Mid Atlantic Retina
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
University of Pittsburgh Medical Center Eye Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Innovative Clinical Research
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29605
Country
United States
Facility Name
Austin Retina Associates
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Texas Retina Associates
City
Dallas
State/Province
Texas
ZIP/Postal Code
75231
Country
United States
Facility Name
Retina Consultants of Houston
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
Foresight Studies, LLC
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78233
Country
United States
Facility Name
Retina Consultants of Houston
City
The Woodlands
State/Province
Texas
ZIP/Postal Code
77384
Country
United States
Facility Name
Virginia Eye Consultants
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Vitreoretinal Associates of Washington
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98004
Country
United States
Facility Name
L V Prasad Eye Hospital
City
Hyderabad
State/Province
Andhra Pradesh
Country
India
Facility Name
Sri Sankaradeva Nethralaya
City
Guwahati
State/Province
Assam
Country
India
Facility Name
M&J Western Regional Institute of Ophthalmology
City
Ahmedabad
State/Province
Gujarat
Country
India
Facility Name
JSS Hospital
City
Mysore
State/Province
Karnataka
Country
India
Facility Name
Regional Institute of Ophthalmology
City
Thiruvananthapuram
State/Province
Kerala
Country
India
Facility Name
TN Medical College and BYL Nair Hospital
City
Mumbai
State/Province
Maharashtra
Country
India
Facility Name
PBMA's H V Desai Eye Hospital
City
Pune
State/Province
Maharashtra
Country
India
Facility Name
Sankara Nethralaya
City
Chennai
State/Province
Tamil Nadu
Country
India
Facility Name
Sankara Eye Hospital
City
Coimbatore
State/Province
Tamil Nadu
Country
India
Facility Name
King George's Medical University
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Sanjay Gandhi Postgraduate Institute of Medical Sciences
City
Lucknow
State/Province
Uttar Pradesh
Country
India
Facility Name
Icare Eye Hospital & PG Institute
City
Noida
State/Province
Uttar Pradesh
Country
India
Facility Name
Calcutta Medical Research Institute
City
Kolkata
ZIP/Postal Code
700027
Country
India
Facility Name
Disha Eye Hospital
City
Kolkata
Country
India
Facility Name
Dr Rajendra Prasad Centre for Ophthalmic Sciences
City
New Delhi
ZIP/Postal Code
110029
Country
India
Facility Name
Dr. Shroff's Charity Eye Hospital
City
New Delhi
Country
India
Facility Name
Soroka Medical Center
City
Beer Sheva
ZIP/Postal Code
85025
Country
Israel
Facility Name
Bnai Zion Medical Center
City
Haifa
ZIP/Postal Code
3104802
Country
Israel
Facility Name
Rambam Health Corp
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
Hadassah-Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Rabin Medical Center
City
Petah Tikva
ZIP/Postal Code
4941492
Country
Israel
Facility Name
Sheba Medical Center
City
Ramat Gan
ZIP/Postal Code
52621
Country
Israel
Facility Name
Kaplan Medical Center
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
Tel-Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
36399237
Citation
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. 2023 Feb;12(1):577-591. doi: 10.1007/s40123-022-00603-x. Epub 2022 Nov 18.
Results Reference
derived
PubMed Identifier
36055922
Citation
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.
Results Reference
derived
PubMed Identifier
34741564
Citation
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.
Results Reference
derived
PubMed Identifier
34322164
Citation
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.
Results Reference
derived

Learn more about this trial

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

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