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NCT Number: NCT02952001

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

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.

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Key information

Conditions

Uveitis Eye Diseases Panuveitis Uveal Diseases Uveitis, Anterior Uveitis, Intermediate Uveitis, Posterior

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Sri Sankaradeva Nethralaya, Guwahati, Assam, India

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About this study

This is a non-interventional, observation extension study of up to 6 months for subjects completing the Parent study, CLS1001-301 (NCT02595398). The Parent study is a Phase 3, multicenter study to assess the safety and efficacy of 4 mg of CLS-TA administered via suprachoroidal injection compared to a sham procedure in the treatment of subjects with macular edema associated with non-infectious uveitis.

The design of the Extension study includes 4 clinic visits over a maximum of 24 weeks. Subject eligibility will be established at Visit 1 during the crossover day from the Parent study to the extension study (Day 0). Follow-up visits will be conducted every 6 weeks up to 24 weeks (Visit 4). At Visit 4, subjects will have a final evaluation conducted 24 weeks following study entry (48 weeks from Parent study randomization).

This study was initiated prior to the completion of the parent study, therefore treatment assignment was masked prior to study entry.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

4 mg CLS-TA Suprachoriodal Injection

Drug

This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.

Other names: Triamcinolone Acetonide

Sham procedure

Drug

This drug was administered in the Parent study, CLS1001-301 (NCT02595398). No study treatments were administered during this observational extension study.

Other names: suprachoroidal sham

Primary outcomes

  1. Time to Additional Therapy for Uveitis

    Time frame: 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).

Secondary outcomes

  1. Number of Participants With Treatment Emergent Adverse Events and Serious Adverse Events

    Time frame: 6 months following exit from Parent study

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

  2. Mean Change From Baseline in Central Subfield Thickness

    Time frame: 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.

  3. Mean Change From Baseline in Best Corrected Visual Acuity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Clearside Biomedical, Inc.

Industry

Registry information

Official study title

MAGNOLIA: Multi-Center, Non-Interventional Extension Study of the Safety and Efficacy of CLS-TA for the Treatment of Macular Edema Associated With Non-Infectious Uveitis

Important dates

Study start
2017
Primary completion
2018
Study completion
2018
First posted
Nov 1, 2016
Registry last updated
Jun 2, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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