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NCT02952001

MAGNOLIA: Extension Study of Patients With Non-infectious Uveitis Who Participated in CLS1001-301

Completed Results posted Last updated 2 June 2021
What this trial tests

trial testing 4 mg CLS-TA Suprachoriodal Injection in Uveitis in 33 participants. Completed in 22 May 2018.

Timeline
13 December 2017
Primary endpoint
22 May 2018
22 May 2018

Quick facts

Lead sponsorClearside Biomedical, Inc.
StatusCompleted
Study typeOBSERVATIONAL
Enrollment33
Start date13 December 2017
Primary completion22 May 2018
Estimated completion22 May 2018
Sites16 locations across United States, India

Drugs / interventions tested

Conditions studied

Sponsor

Clearside Biomedical, Inc. — full company profile →

Who can join

18 and older, any sex, with Uveitis or Uveitis, Posterior. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Time to Additional Therapy for Uveitis Primary · 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year

This time to event outcome was calculated as the number of days between the date of initiation of additional therapy for uveitis and the date of first treatment in the Parent study CLS1001-301 (NCT02595398).

GroupValue95% CI
4 mg CLS-TA Suprachoriodal Injection344.0282.0 – NA
Sham Procedure332.0280.0 – NA
Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events Secondary · 6 months following exit from Parent study

Number of participants with treatment emergent adverse events and serious adverse events reported during the extension study.

Treatment-emergent adverse events
GroupValue95% CI
4 mg CLS-TA Suprachoriodal Injection16
Sham Procedure3
Serious adverse events
GroupValue95% CI
4 mg CLS-TA Suprachoriodal Injection1
Sham Procedure0
Mean Change From Baseline in Central Subfield Thickness Secondary · 6 months following exit from Parent study

Central subfield thickness (CST) is a diagnostic measurement used in identifying the presence of edema in the circular area 1 mm in diameter centered around the fovea. CST was measured using spectral domain optical coherence tomography (SD-OCT). A masked reading center graded the SD-OCT digital images. A negative change from baseline value represents a reduction in macular edema.

GroupValue95% CI
4 mg CLS-TA Suprachoriodal Injection-174.5± 145.70
Sham Procedure19.5± 0.71
Mean Change From Baseline in Best Corrected Visual Acuity Secondary · 6 months following exit from Parent study

Best corrected visual acuity (BCVA) refers to the measurement of the best possible vision that can be achieved following refraction or correction. BCVA was assessed following the Early Treatment Diabetic Retinopathy Study (ETDRS) protocol and was measured in the number of letters read correctly on an ETDRS eye chart. An increase from the pre-treatment state in BCVA of 15 letters or more represents a clinically meaningful improvement.

GroupValue95% CI
4 mg CLS-TA Suprachoriodal Injection12.1± 13.00
Sham Procedure14.0± 15.56

Adverse events — posted to ClinicalTrials.gov

Time frame: 6 months following completion of the Parent study CLS1001-301 (NCT02595398), for a total of up to 1 year.. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

4 mg CLS-TA Suprachoriodal Injection
Serious: 1/28 (4%)
Deaths: 0/28
Sham Procedure
Serious: 0/5 (0%)
Deaths: 0/5

Serious adverse events (6 terms)

ReactionSystem4 mg CLS-TA Suprachoriodal…Sham Procedure
Oesophageal achalasiaGastrointestinal disorders
PneumoniaInfections and infestations
Septic shockInfections and infestations
Acute kidney injuryRenal and urinary disorders
Acute respiratory failureRespiratory, thoracic and mediastinal disorders
Pneumonia aspirationRespiratory, thoracic and mediastinal disorders
Other adverse events (12 terms — click to expand)

ReactionSystem4 mg CLS-TA Suprachoriodal…Sham Procedure
Cataract subcapsularEye disorders
UveitisEye disorders
Intraocular pressure increasedInvestigations
CataractEye disorders
Eye painEye disorders
UveitisEye disorders
Infection parasiticInfections and infestations
Eosinophil count increasedInvestigations
Cataract corticalEye disorders
Macular fibrosisEye disorders
Macular oedemaEye disorders
Cataract corticalEye disorders

Most-reported serious reactions: Oesophageal achalasia, Pneumonia, Septic shock, Acute kidney injury, Acute respiratory failure, Pneumonia aspiration.

Data from ClinicalTrials.gov NCT02952001 adverse events section.

Sponsor's own description

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.

Publications & conference data

8 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Non-transdermal microneedles for advanced drug delivery.
    Lee K, Goudie MJ, Tebon P, Sun W, et al · · 2020 · cited 76× · PMID 31837356 · DOI 10.1016/j.addr.2019.11.010
  2. Drug Delivery via the Suprachoroidal Space for the Treatment of Retinal Diseases.
    Naftali Ben Haim L, Moisseiev E. · · 2021 · cited 41× · PMID 34206925 · DOI 10.3390/pharmaceutics13070967
  3. Extension study of the safety and efficacy of CLS-TA for treatment of macular oedema associated with non-infectious uveitis (MAGNOLIA).
    Khurana RN, Merrill P, Yeh S, Suhler E, et al · · 2022 · cited 36× · PMID 33712478 · DOI 10.1136/bjophthalmol-2020-317560
  4. Microinjection via the suprachoroidal space: a review of a novel mode of administration.
    Ciulla T, Yeh S. · · 2022 · cited 18× · PMID 36395492 · DOI 10.37765/ajmc.2022.89270
  5. Triamcinolone acetonide injectable suspension for suprachoroidal use in the treatment of macular edema associated with uveitis.
    Thomas J, Kim L, Albini T, Yeh S. · · 2022 · cited 11× · PMID 36060305 · DOI 10.1080/17469899.2022.2114456
  6. What's New in Ocular Drug Delivery: Advances in Suprachoroidal Injection since 2023.
    Wu KY, Gao A, Giunta M, Tran SD. · · 2024 · cited 10× · PMID 39204112 · DOI 10.3390/ph17081007
  7. Beyond the injection: delivery systems reshaping retinal disease management.
    Rowe LW, Akotoye C, Harris A, Ciulla TA. · · 2025 · cited 6× · PMID 40319468 · DOI 10.1080/14656566.2025.2496424
  8. Suprachoroidal Drug Delivery for Macular Edema Associated With Noninfectious Uveitis.
    Huang Y, Choo C, Hancock S, Ciulla TA, et al · · 2024 · cited 6× · PMID 39148567 · DOI 10.1177/24741264241246314

Verify or expand the search:

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Other Clearside Biomedical, Inc. trials

Trials by the same sponsor.

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