Phase 3
Completed N=38
Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis
uveitis · Uveitis, Posterior · Uveitis, Anterior · Uveitis, Intermediate
Source: ClinicalTrials.gov NCT03097315 ↗
Enrolled (actual)
38
Serious AEs
2.6%
Results posted
Jun 2021
Primary outcomePrimary: Adverse Events — 27; 1 Participants
◆ Published Evidence
Emerging
10citations · ~3 / year
Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies.
Summary
This open-label study is designed to evaluate the safety of suprachoroidally administered triamcinolone acetone injectable suspension, CLS-TA, in patients with non-infectious uveitis with and without macular edema.
Linked Publications (2)
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Triamcinolone Acetonide Suprachoroidal Injectable Suspension for Uveitic Macular Edema: Integrated Analysis of Two Phase 3 Studies.
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Suprachoroidal triamcinolone acetonide injectable suspension for macular edema associated with noninfectious uveitis: an in-depth look at efficacy and safety.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Adverse Events |
27; 1 | — |
| SECONDARY Mean Intraocular Pressure in the Study Eye |
13.3; 15.2 | — |
| SECONDARY Number of Patients With a Grade of 0 in Anterior Chamber Cells in the Study Eye |
17; 31 | — |
| SECONDARY Number of Patients With a Grade of 0 in Anterior Chamber Flare in the Study Eye |
27; 34 | — |
| SECONDARY Number of Patients With a Grade of 0 in Vitreous Haze in the Study Eye |
17; 34 | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of active or inactive non-infectious uveitis (pan, anterior, intermediate and posterior)
- ETDRS BCVA score of ≥ 5 letters read in the study eye
Exclusion Criteria
- Any active ocular disease or infection in the study eye other than uveitis
- Intraocular pressure > 22 mmHg or uncontrolled glaucoma in the study eye; patients with IOP of 22 or less in the study eye not excluded with no more than 2 IOP-lowering medications.
- Any uncontrolled systemic disease that, in the opinion of the Investigator, would preclude participation in the study
- Any topical ocular corticosteroid in the 10 days prior to baseline; intraocular or periocular corticosteroid injections in the 2 months prior to baseline; an OZURDEX implant in the 6 months prior to baseline; RETISERT or ILUVIEN implant in the 3 years prior to baseline.
Data sourced from ClinicalTrials.gov (NCT03097315) and the linked publication. 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.