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Suprachoroidal Injection of CLS-TA in Subjects With Macular Edema Associated With Non-infectious Uveitis

NCT02595398 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 160

Last updated 2021-05-28

Study results available
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Summary

The study is designed to evaluate the safety and efficacy of suprachoroidally administered triamcinolone acetonide, CLS-TA, in subjects with macular edema associated with non-infectious uveitis.

Conditions

  • Uveitis
  • Uveitis, Posterior
  • Uveitis, Anterior
  • Uveitis, Intermediate
  • Panuveitis

Interventions

DRUG

4mg CLS-TA Suprachoriodal Injection

CLS-TA, 40 mg/mL (4 mg in 100 µL), administered as a single injection at 2 timepoints

DRUG

Sham Procedure

Sham procedure administered at 2 timepoints

Sponsors & Collaborators

  • Clearside Biomedical, Inc.

    lead INDUSTRY

Principal Investigators

  • Thomas Cuilla, MD, MBA · Clearside Biomedical, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-11-17
Primary Completion
2018-01-18
Completion
2018-01-18
FDA Drug
Yes

Countries

  • United States
  • India
  • Israel

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02595398 on ClinicalTrials.gov