Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing (OPTICS)

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.

Study Overview

• Status: Recruiting
• Conditions: Uveitis; Infectious Disease
• Intervention / Treatment: Diagnostic test: Standard of Care (SOC); Device: Metagenomic Deep Sequencing (MDS)

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jessica Shantha, MD; Phone Number: (415) 476-1442; Email: Jessica.shantha@ucsf.edu
• Study Contact Backup: Name: Thuy Doan, MD, PhD; Phone Number: 415-476-6939

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94158
      • Recruiting
      • University of California San Francisco (UCSF)
      • Contact: Thuy Doan, MD, PhD; Phone Number: 415-476-6939
      • Contact: Jessica Shantha, MD, MAS; Email: Jessica.Shantha@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Clinical improvement	Dichotomous variable (Y/N) as assessed by a masked evaluator	4-week after randomization
Appropriate therapy	Dichotomous variable (Y/N) as determined by an independent expert panel	4-week after randomization

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Provider certainty of belief	Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%)	4-week after randomization
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
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
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

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: University of California, Los Angeles; University of California, Davis; University of Utah; University of Nebraska

Study record dates

Study Major Dates

• Study Start (Actual): June 6, 2022
• Primary Completion (Anticipated): December 1, 2026
• Study Completion (Anticipated): December 1, 2026

Study Registration Dates

• First Submitted: February 23, 2022
• First Submitted That Met QC Criteria: March 8, 2022
• First Posted (Actual): March 18, 2022

Study Record Updates

• Last Update Posted (Actual): July 7, 2022
• Last Update Submitted That Met QC Criteria: July 5, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Uveitis; MDS; Metagenomic deep sequencing; Intraocular infection
• Additional Relevant MeSH Terms: Pathologic Processes; Eye Diseases; Disease Attributes; Uveal Diseases; Infections; Communicable Diseases; Uveitis
• Other Study ID Numbers: P0555674

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No