Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

NCT ID: NCT01789320

Last Updated: 2021-02-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 11 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-02-28
• Study Completion Date: 2015-03-31

Brief Summary

This study is designed to determine the safety and tolerability of a single microinjection of triamcinolone acetonide (TRIESENCE®) into the suprachoroidal space (SCS) of patients who have non-infectious uveitis.

Detailed Description

This is a Phase 1/2, open-label study designed to evaluate the safety, tolerability and procedure of a microneedle injection of triamcinolone acetonide (TA) into the SCS. The subjects enrolled in this study will be chosen from subjects with non-infectious intermediate, posterior and pan-uveitis. The injection will only be administered to a single eye via the Clearside Biomedical proprietary microneedle into the SCS. The dose of TA to be injected is 4 mg of currently approved TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL). The study design includes 10 clinic visits over 27 weeks. Subjects will be followed for 26 weeks following treatment with TRIESENCE®.

Conditions

Uveitis; Intermediate Uveitis; Posterior Uveitis; Panuveitis; Noninfectious Uveitis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

triamcinolone acetonide (Triesence®)

TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) in a total volume of 100 uL administered via microneedle directly to the suprachoroidal space (SCS)

Group Type: EXPERIMENTAL

triamcinolone acetonide (Triesence®)

Intervention Type: DRUG

4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space

Interventions

triamcinolone acetonide (Triesence®)

4 mg of TRIESENCE® (triamcinolone acetonide injectable suspension 40 mg/mL) administered as a single injection to the suprachoroidal space

Intervention Type: DRUG

Other Intervention Names

triamcinolone acetonide; TA; Triesence; corticosteroid

Eligibility Criteria

Inclusion Criteria

• diagnosis of non-infectious intermediate, posterior or pan-uveitis

Exclusion Criteria

• any ocular trauma within the past 6 months in the study eye
• any injection of intraocular corticosteroids or steroid implant or the Ozurdex® implant in the 6 months prior to the study treatment, or any prior use of Retisert™ in the study eye
• any uncontrolled systemic disease that would preclude participation in the study or put the subject at risk due to study treatment or procedures
• have a known HIV infection or other immunodeficiency disease for which corticosteroid therapy would be contraindicated
• are monocular
• have ocular hypertension
• history of any intraocular surgery in the study eye
• presence of an anterior staphyloma in the study eye

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Clearside Biomedical, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Thomas Ciulla, MD

Role: STUDY_DIRECTOR

Clearside Biomedical, Inc.

Locations

Northwestern University

Chicago, Illinois, United States

University of Nebraska Medical Center

Omaha, Nebraska, United States

Cleveland Clinic Foundation

Cleveland, Ohio, United States

Countries

United States

References

Goldstein DA, Do D, Noronha G, Kissner JM, Srivastava SK, Nguyen QD. Suprachoroidal Corticosteroid Administration: A Novel Route for Local Treatment of Noninfectious Uveitis. Transl Vis Sci Technol. 2016 Dec 14;5(6):14. doi: 10.1167/tvst.5.6.14. eCollection 2016 Dec.

Reference Type: DERIVED

PMID: 27980877 (View on PubMed)

Other Identifiers

CLS1001-101

Identifier Type: -

Identifier Source: org_study_id