OPTICS: Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT05286203

Collaborator

University of Nebraska (Other), University of Utah (Other), University of California, Davis (Other), University of California, Los Angeles (Other)

100

Enrollment

Location

Arms

53.8

Anticipated Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Uveitis Infectious Disease	Device: Metagenomic Deep Sequencing (MDS) Diagnostic Test: Standard of Care (SOC)	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Diagnostic

Official Title:

Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

Actual Study Start Date :

Jun 6, 2022

Anticipated Primary Completion Date :

Dec 1, 2026

Anticipated Study Completion Date :

Dec 1, 2026

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Standard of Care Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.	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.
Experimental: MDS Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.	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.

Arm

Intervention/Treatment

Active Comparator: Standard of Care

Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.

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.

Experimental: MDS

Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.

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.

Outcome Measures

Primary Outcome Measures

Clinical improvement [4-week after randomization]
Dichotomous variable (Y/N) as assessed by a masked evaluator
Appropriate therapy [4-week after randomization]
Dichotomous variable (Y/N) as determined by an independent expert panel

Secondary Outcome Measures

Provider certainty of belief [4-week after randomization]
Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%)
Patient quality of life [4-week after randomization]
As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)
Infection status [4-week after randomization]
Estimated through latent class analysis that compares MDS with traditional tests for presumed ocular infections. Sensitivity and specificity will be reported as percentage (%)
Provider quality of care [4-week after randomization]
As measured by the World Health Organization Quality of Life Abbreviated Questionnaire (min = 0, max = 100; higher means better quality of life).

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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