Clinical trial NCT03097315: Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis
Official title: Open-label Safety Study of Suprachoroidal Triamcinolone Acetonide Injectable Suspension in Patients 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: 2017-03-31
Enrollment: 38
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.

Detailed description: This is a Phase 3, open-label multicenter study to assess the safety of 4 mg of CLS-TA administered via suprachoroidal injection in the treatment of patients diagnosed with noninfectious uveitis with and without macular edema.

Qualified patients will be enrolled and receive two suprachoroidal injections of CLS-TA 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 active or inactive non-infectious uveitis (pan, anterior, intermediate and posterior)
* ETDRS BCVA score of ≥ 5 letters read 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; patients with IOP of 22 or less in the study eye not excluded 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: Adverse Events
timeFrame: Baseline to 24 weeks
Secondary outcomes:
measure: Mean Intraocular Pressure in the Study Eye
timeFrame: Baseline, 24 Weeks
measure: Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye
timeFrame: Baseline, 24 Weeks
measure: Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye
timeFrame: Baseline, 24 Weeks
measure: Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye
timeFrame: Baseline, 24 Weeks
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Retinal Consultants of Arizona
state: Arizona
city: Beverly Hills
country: United States
facility: Retina-Vitreous Associates Medical Group
state: California
city: Mountain View
country: United States
facility: Northern California Retina Vitreous Associates Medical Group, Inc.
state: California
city: Fort Lauderdale
country: United States
facility: Retina Group of Florida
state: Florida
city: Marietta
country: United States
facility: Marietta Eye Clinic
state: Georgia
city: Indianapolis
country: United States
facility: Midwest Eye Retina Practicing at Midwest Eye Institute
state: Indiana
city: Boston
country: United States
facility: Ophthalmic Consultants of Boston
state: Massachusetts
city: Dallas
country: United States
facility: Texas Retina Associates
state: Texas
city: Houston
country: United States
facility: Retina Consultants of Houston
state: Texas
city: Norfolk
country: United States
facility: Virginia Eye Consultants
state: Virginia
Study officials:
affiliation: Clearside Biomedical, Inc.
name: Thomas Ciulla, MD
role: STUDY_DIRECTOR
References:
citation: Jabs DA, Nussenblatt RB, Rosenbaum JT; Standardization of Uveitis Nomenclature (SUN) Working Group. Standardization of uveitis nomenclature for reporting clinical data. Results of the First International Workshop. Am J Ophthalmol. 2005 Sep;140(3):509-16. doi: 10.1016/j.ajo.2005.03.057.
citation: Nussenblatt RB, Palestine AG, Chan CC, Roberge F. Standardization of vitreal inflammatory activity in intermediate and posterior uveitis. Ophthalmology. 1985 Apr;92(4):467-71. doi: 10.1016/s0161-6420(85)34001-0.
citation: Lowder C, Belfort R Jr, Lightman S, Foster CS, Robinson MR, Schiffman RM, Li XY, Cui H, Whitcup SM; Ozurdex HURON Study Group. Dexamethasone intravitreal implant for noninfectious intermediate or posterior uveitis. Arch Ophthalmol. 2011 May;129(5):545-53. doi: 10.1001/archophthalmol.2010.339. Epub 2011 Jan 10.
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.