Phase 2
N=22
Suprachoroidal Injection of Triamcinolone Acetonide in Subjects With Macular Edema Following Non-Infectious Uveitis
Uveitis · Macular Edema · Uveitis, Posterior · Uveitis, Anterior · Panuveitis
Bottom Line
View on ClinicalTrials.gov: NCT02255032 ↗Enrolled (actual)
22
Serious AEs
4.6%
Results posted
Feb 2021
Primary outcome: Primary: Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis — -164.44; -78.20 Microns — p=0.0017
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- 4 mg CLS-TA (Drug); 0.8 mg CLS-TA (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clearside Biomedical, Inc.
- Primary completion
- Dec 2015
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Central Subfield Thickness, Measured Using Optical Coherence Tomography, After Treatment With CLS-TA in Subjects With Macular Edema Following Uveitis |
-164.44; -78.20 | 0.0017 sig |
Summary
The study is designed to evaluate the safety and efficacy of triamcinolone acetonide, CLS-TA, in subjects with macular edema following non-infectious uveitis. A single suprachoroidal injection of one of two doses of CLS-TA will each be evaluated in subjects with macular edema following non-infectious uveitis.
Eligibility Criteria
Inclusion Criteria
- diagnosis of noninfectious uveitis
- diagnosis of macular edema associated with noninfectious uveitis
Exclusion Criteria
- any ocular trauma within the immediate 6 months prior to treatment
- any photocoagulation or cryotherapy in the 6 months prior to treatment
- any IVT injection of anti-VEGF treatment in the 2 months prior to treatment
- any eye diseases other than uveitis and ME that could compromise central visual acuity
- any previous suprachoroidal injection of triamcinolone acetonide in the study eye
Data sourced from ClinicalTrials.gov (NCT02255032). 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.