Phase 2
N=11
Safety Study of Suprachoroidal Triamcinolone Acetonide Via Microneedle to Treat Uveitis
Uveitis · Intermediate Uveitis · Posterior Uveitis · Panuveitis · Noninfectious Uveitis
Bottom Line
View on ClinicalTrials.gov: NCT01789320 ↗Enrolled (actual)
11
Serious AEs
9.1%
Results posted
Feb 2021
Primary outcome: Primary: Change in Intraocular Pressure (IOP) — -0.1 mm Hg
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- triamcinolone acetonide (Triesence®) (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clearside Biomedical, Inc.
- Primary completion
- Mar 2015
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 | — |
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.
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
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.