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Uveitis | Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

Uveitis research study

What is the primary objective of this study?

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.

Who is eligible to participate?

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

Which medical condition, disease, disorder, syndrome, illness, or injury is researched?

Uveitis

Intermediate Uveitis

Posterior Uveitis

Panuveitis

Noninfectious Uveitis

Study Interventions

Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.

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

Study Arms

Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.

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)

Study Status

Completed

Start Date: February 2013

Completed Date: March 2015

Phase: Phase 1/Phase 2

Type: Interventional

Design:

Primary Outcome: Incidence of adverse events

Secondary Outcome: Central subfield thickness using optical coherence tomography (OCT)

Study sponsors, principal investigator, and references

Principal Investigator: Glenn Noronha, PhD

Lead Sponsor: Clearside Biomedical, Inc.

Collaborator:

More information:https://clinicaltrials.gov/show/NCT01789320

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