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Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing (OPTICS)

Primary Purpose

Uveitis, Infectious Disease

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Metagenomic Deep Sequencing (MDS)
Standard of Care (SOC)
Sponsored by
University of California, San Francisco
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Uveitis focused on measuring Uveitis, Metagenomic deep sequencing, Intraocular infection, MDS

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Exclusion Criteria:

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

Sites / Locations

  • University of California San Francisco (UCSF)Recruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Standard of Care

MDS

Arm Description

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

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

Outcomes

Primary Outcome Measures

Clinical improvement
Dichotomous variable (Y/N) as assessed by a masked evaluator
Appropriate therapy
Dichotomous variable (Y/N) as determined by an independent expert panel

Secondary Outcome Measures

Provider certainty of belief
Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%)
Patient quality of life
As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)
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 (%)
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).

Full Information

First Posted
February 23, 2022
Last Updated
July 5, 2022
Sponsor
University of California, San Francisco
Collaborators
University of Nebraska, University of Utah, University of California, Davis, University of California, Los Angeles
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1. Study Identification

Unique Protocol Identification Number
NCT05286203
Brief Title
Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
Acronym
OPTICS
Official Title
Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Recruiting
Study Start Date
June 6, 2022 (Actual)
Primary Completion Date
December 2026 (Anticipated)
Study Completion Date
December 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
University of Nebraska, University of Utah, University of California, Davis, University of California, Los Angeles

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Uveitis, Infectious Disease
Keywords
Uveitis, Metagenomic deep sequencing, Intraocular infection, MDS

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Standard of Care
Arm Type
Active Comparator
Arm Description
Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.
Arm Title
MDS
Arm Type
Experimental
Arm Description
Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.
Intervention Type
Device
Intervention Name(s)
Metagenomic Deep Sequencing (MDS)
Intervention Description
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.
Intervention Type
Diagnostic Test
Intervention Name(s)
Standard of Care (SOC)
Intervention Description
SOC includes any available diagnostic tests, such as Gram stain, cultures, PCRs, that are considered the appropriate testing based on the clinical findings.
Primary Outcome Measure Information:
Title
Clinical improvement
Description
Dichotomous variable (Y/N) as assessed by a masked evaluator
Time Frame
4-week after randomization
Title
Appropriate therapy
Description
Dichotomous variable (Y/N) as determined by an independent expert panel
Time Frame
4-week after randomization
Secondary Outcome Measure Information:
Title
Provider certainty of belief
Description
Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%)
Time Frame
4-week after randomization
Title
Patient quality of life
Description
As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)
Time Frame
4-week after randomization
Title
Infection status
Description
Estimated through latent class analysis that compares MDS with traditional tests for presumed ocular infections. Sensitivity and specificity will be reported as percentage (%)
Time Frame
4-week after randomization
Title
Provider quality of care
Description
As measured by the World Health Organization Quality of Life Abbreviated Questionnaire (min = 0, max = 100; higher means better quality of life).
Time Frame
4-week after randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jessica Shantha, MD
Phone
(415) 476-1442
Email
Jessica.shantha@ucsf.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Thuy Doan, MD, PhD
Phone
415-476-6939
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thuy Doan, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California San Francisco (UCSF)
City
San Francisco
State/Province
California
ZIP/Postal Code
94158
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica Shantha, MD, MAS
Email
Jessica.Shantha@ucsf.edu
First Name & Middle Initial & Last Name & Degree
Thuy Doan, MD, PhD
Phone
415-476-6939

12. IPD Sharing Statement

Plan to Share IPD
No

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Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

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