Clinical trial NCT02595398: Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis
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
Overall status: COMPLETED
Phase: PHASE3
Conditions: 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
Lead sponsor: Clearside Biomedical, Inc.
Sponsor class: INDUSTRY
First posted: 2015-11-03
Enrollment: 160
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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.

Primary outcomes:
measure: Number of Subjects Demonstrating ≥ 15 Letter Improvement From Baseline in Best Corrected Visual Acuity at 24 Weeks
timeFrame: Baseline, 24 weeks
Secondary outcomes:
measure: Mean Change From Baseline in Central Subfield Thickness
timeFrame: Baseline, 24 weeks
measure: Number of Subjects With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs)
timeFrame: Baseline to 24 weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Tucson
country: United States
facility: Retina Centers, PC
state: Arizona
city: Bakersfield
country: United States
facility: California Retina Consultants
state: California
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Los Angeles
country: United States
facility: USC Eye Institute
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, Inc.
state: California
city: Santa Ana
country: United States
facility: Orange County Retina Medical Group
state: California
city: Aurora
country: United States
facility: University of Colorado
state: Colorado
city: Golden
country: United States
facility: Colorado Retina Associates
state: Colorado
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Lakeland
country: United States
facility: Center for Retina and Macular Disease
state: Florida
city: Atlanta
country: United States
facility: Emory Eye Center Emory University
state: Georgia
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Chicago
country: United States
facility: Northwestern University
state: Illinois
city: Chicago
country: United States
facility: University of Illinois at Chicago
state: Illinois
city: Oak Park
country: United States
facility: Illinois Retina Associates, S.C.
state: Illinois
city: Indianapolis
country: United States
facility: Midwest Eye Retina Practicing at Midwest Eye Institute
state: Indiana
city: Baltimore
country: United States
facility: Elman Retina Group, PA
state: Maryland
city: Chevy Chase
country: United States
facility: The Retina Group of Washington
state: Maryland
city: Ayer
country: United States
facility: Valley Eye Physicians and Surgeons, PC
state: Massachusetts
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Waltham
country: United States
facility: Ocular Immunology and Uveitis Foundation; Massachusetts Eye Research and Surgery Institution
state: Massachusetts
city: Independence
country: United States
facility: Discover Vision Centers
state: Missouri
city: Palisades Park
country: United States
facility: Metropolitan Eye Research & Surgery Institute
state: New Jersey
city: New York
country: United States
facility: Weill Cornell Medical College
state: New York
city: Slingerlands
country: United States
facility: Retina Consultants PLLC
state: New York
city: Belmont
country: United States
facility: Charlotte Eye Ear Nose and Throat Associates, PA
state: North Carolina
city: Winston-Salem
country: United States
facility: Wake Forest Baptist Health Eye Center
state: North Carolina
city: Fargo
country: United States
facility: Bergstrom Eye Research
state: North Dakota
city: Portland
country: United States
facility: Oregon Health & Science University Casey Eye Institute
state: Oregon
city: Philadelphia
country: United States
facility: Mid Atlantic Retina
state: Pennsylvania
city: Pittsburgh
country: United States
facility: University of Pittsburgh Medical Center Eye Center
state: Pennsylvania
city: Greenville
country: United States
facility: Innovative Clinical Research
state: South Carolina
city: Austin
country: United States
facility: Austin Retina Associates
state: Texas
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: San Antonio
country: United States
facility: Foresight Studies, LLC
state: Texas
city: The Woodlands
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
city: Bellevue
country: United States
facility: Vitreoretinal Associates of Washington
state: Washington
city: Hyderabad
country: India
facility: L V Prasad Eye Hospital
state: Andhra Pradesh
city: Guwahati
country: India
facility: Sri Sankaradeva Nethralaya
state: Assam
city: Ahmedabad
country: India
facility: M&J Western Regional Institute of Ophthalmology
state: Gujarat
city: Mysore
country: India
facility: JSS Hospital
state: Karnataka
city: Thiruvananthapuram
country: India
facility: Regional Institute of Ophthalmology
state: Kerala
city: Mumbai
country: India
facility: TN Medical College and BYL Nair Hospital
state: Maharashtra
city: Pune
country: India
facility: PBMA's H V Desai Eye Hospital
state: Maharashtra
city: Chennai
country: India
facility: Sankara Nethralaya
state: Tamil Nadu
city: Coimbatore
country: India
facility: Sankara Eye Hospital
state: Tamil Nadu
city: Lucknow
country: India
facility: King George's Medical University
state: Uttar Pradesh
city: Lucknow
country: India
facility: Sanjay Gandhi Postgraduate Institute of Medical Sciences
state: Uttar Pradesh
city: Noida
country: India
facility: Icare Eye Hospital & PG Institute
state: Uttar Pradesh
city: Kolkata
country: India
facility: Calcutta Medical Research Institute
city: Kolkata
country: India
facility: Disha Eye Hospital
city: New Delhi
country: India
facility: Dr Rajendra Prasad Centre for Ophthalmic Sciences
city: New Delhi
country: India
facility: Dr. Shroff's Charity Eye Hospital
city: Beer Sheva
country: Israel
facility: Soroka Medical Center
city: Haifa
country: Israel
facility: Bnai Zion Medical Center
city: Haifa
country: Israel
facility: Rambam Health Corp
city: Jerusalem
country: Israel
facility: Hadassah-Hebrew University Medical Center
city: Petah Tikva
country: Israel
facility: Rabin Medical Center
city: Ramat Gan
country: Israel
facility: Sheba Medical Center
city: Rehovot
country: Israel
facility: Kaplan Medical Center
city: Tel Aviv
country: Israel
facility: Tel-Aviv Sourasky Medical Center
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Thomas Cuilla, MD, MBA
role: STUDY_DIRECTOR
References:
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.
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.
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.
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.