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Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

About

Brief Summary

This is a multi-center randomized controlled evaluator-masked trial designed to compare metagenomic deep sequencing (MDS) versus standard of care testing for improvement of outcomes for intraocular infections. Patients with presumed intraocular infections who meet the eligibility criteria will be randomized to receive MDS testing results or not to receive MDS testing results. All patients will receive standard-of-care testing to guide management. Enrolled patients will be followed at week 2, week 3-6 (randomization visit), and at 4 weeks after the randomization visit. The proportions of patients who received the appropriate therapy and the proportions of patients with improved outcome will be compared between arms. Patient quality of life, MDS performance, and the provider certainly of belief will be collected.

Primary Purpose
Diagnostic
Study Type
Interventional
Phase
Phase 3

Eligibility

Gender
All
Healthy Volunteers
No
Minimum Age
18 Years
Maximum Age
N/A

Inclusion Criteria:

  • Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis
  • Presumed post-operative endophthalmitis
  • Unilateral or bilateral
  • 18 years and older

Exclusion Criteria:

  • Insufficient specimen for MDS
  • Age < 18 years of age
  • Pregnancy
  • Unable to consent

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Study Stats
Protocol No.
22-000766
Category
Eye/Ocular Disorders
Principal Investigator
Contact
Joseph Privratsky
Location
  • UCLA Pasadena
  • UCLA Westwood
For Providers
NCT No.
NCT05286203
For detailed technical eligibility, visit ClinicalTrials.gov.