Phase 2 Completed N=11 Treatment

Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis

uveitis · Intermediate Uveitis · Posterior Uveitis · Panuveitis

Source: ClinicalTrials.gov NCT01789320 ↗

Enrolled (actual)

Serious AEs

9.1%

Results posted

Feb 2021

Primary outcomePrimary: Change in Intraocular Pressure (IOP) — -0.1 mm Hg

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.

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Intraocular Pressure (IOP)	-0.1	—
PRIMARY Best Corrected Visual Acuity	-0.25; -0.28	—
SECONDARY Central Subfield Thickness Using Optical Coherence Tomography (OCT)	-153.7; -107.0	—
SECONDARY Vitreous Haze Grade	-0.75; -0.75	—

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01789320). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.