Phase 3
N=38
Suprachoroidal Injection of CLS-TA in Patients With Non-infectious Uveitis
Uveitis · Uveitis, Posterior · Uveitis, Anterior · Uveitis, Intermediate · Panuveitis
Bottom Line
View on ClinicalTrials.gov: NCT03097315 ↗Enrolled (actual)
38
Serious AEs
2.6%
Results posted
Jun 2021
Primary outcome: Primary: Adverse Events — 27; 1 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- 4 mg CLS-TA Suprachoriodal Injection (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Clearside Biomedical, Inc.
- Primary completion
- Jan 2018
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 | — |
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.
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). 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.