Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Uveitis Clinical Trial

— OPTICS  

Official title:

Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05286203
• Other study ID #: P0555674
• Status: Recruiting
• Phase: N/A
• Start date: June 6, 2022
• Est. completion date: December 2026

Study information

• Verified date: July 2022
• Source: University of California, San Francisco
• Contact: Jessica Shantha, MD
• Phone: (415) 476-1442
• Email: Jessica.shantha[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2026
• Est. primary completion date: December 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Infections
• Infectious Disease
• Uveitis

Intervention

Device:
• Metagenomic Deep Sequencing (MDS)
MDS is an RNA-seq based testing of ocular fluid or tissue to identify potential infectious pathogens including bacteria, fungi, parasites, and DNA and RNA viruses.

Diagnostic Test:
• Standard of Care (SOC)
SOC includes any available diagnostic tests, such as Gram stain, cultures, PCRs, that are considered the appropriate testing based on the clinical findings.

Locations

Country	Name	City	State
United States	University of California San Francisco (UCSF)	San Francisco	California

Sponsors (5)

Lead Sponsor	Collaborator
University of California, San Francisco	University of California, Davis, University of California, Los Angeles, University of Nebraska, University of Utah

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Clinical improvement	Dichotomous variable (Y/N) as assessed by a masked evaluator	4-week after randomization
Primary	Appropriate therapy	Dichotomous variable (Y/N) as determined by an independent expert panel	4-week after randomization
Secondary	Provider certainty of belief	Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%)	4-week after randomization
Secondary	Patient quality of life	As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)	4-week after randomization
Secondary	Infection status	Estimated through latent class analysis that compares MDS with traditional tests for presumed ocular infections. Sensitivity and specificity will be reported as percentage (%)	4-week after randomization
Secondary	Provider quality of care	As measured by the World Health Organization Quality of Life Abbreviated Questionnaire (min = 0, max = 100; higher means better quality of life).	4-week after randomization