N/A
Completed N=33
MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301
uveitis · Uveitis, Posterior · Uveitis, Anterior · Uveitis, Intermediate
Source: ClinicalTrials.gov NCT02952001 ↗
Enrolled (actual)
33
Serious AEs
3.0%
Results posted
May 2021
Primary outcomePrimary: Time to Additional Therapy for Uveitis — 344.0; 332.0 days — p=0.562
Summary
This study is a non-interventional, observational extension of the Parent study, CLS1001-301 (NCT02595398). The purpose of this study is to characterize the continued clinical benefit(s) regarding safety and efficacy of suprachoroidally administered CLS-TA, triamcinolone acetonide injectable suspension, for the treatment of macular edema associated with non-infectious uveitis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time to Additional Therapy for Uveitis |
344.0; 332.0 | 0.562 |
| SECONDARY Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events |
16; 3; 1; 0 | — |
| SECONDARY Mean Change From Baseline in Central Subfield Thickness |
-174.5; 19.5 | — |
| SECONDARY Mean Change From Baseline in Best Corrected Visual Acuity |
12.1; 14.0 | — |
Eligibility Criteria
Inclusion Criteria
- Enrolled in the Parent study, CLS1001-301, through Visit 8/Month 6
- Willing and able to provide written informed consent prior to any study procedures; willing to comply with the instructions and attend all scheduled study visits
Exclusion Criteria
- Received additional therapy for the treatment of uveitis or prohibited medication
- Require additional therapy for the treatment of uveitis or prohibited medication at the time of the Crossover visit
Data sourced from ClinicalTrials.gov (NCT02952001). 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.