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Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing (OPTICS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05286203
Recruitment Status : Recruiting
First Posted : March 18, 2022
Last Update Posted : May 12, 2022
Sponsor:
Collaborators:
University of Nebraska
University of Utah
University of California, Davis
University of California, Los Angeles
Information provided by (Responsible Party):
University of California, San Francisco

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) Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated 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
Estimated Study Start Date : May 2022
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2026

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Clinical improvement [ Time Frame: 4-week after randomization ]
    Dichotomous variable (Y/N) as assessed by a masked evaluator

  2. Appropriate therapy [ Time Frame: 4-week after randomization ]
    Dichotomous variable (Y/N) as determined by an independent expert panel


Secondary Outcome Measures :
  1. Provider certainty of belief [ Time Frame: 4-week after randomization ]
    Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%)

  2. Patient quality of life [ Time Frame: 4-week after randomization ]
    As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)

  3. Infection status [ Time Frame: 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 (%)

  4. Provider quality of care [ Time Frame: 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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05286203


Contacts
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Contact: Jessica Shantha, MD (415) 476-1442 Jessica.shantha@ucsf.edu
Contact: Thuy Doan, MD, PhD 415-476-6939

Locations
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United States, California
University of California San Francisco (UCSF) Recruiting
San Francisco, California, United States, 94158
Contact: Jessica Shantha, MD, MAS       Jessica.Shantha@ucsf.edu   
Contact: Thuy Doan, MD, PhD    415-476-6939      
Sponsors and Collaborators
University of California, San Francisco
University of Nebraska
University of Utah
University of California, Davis
University of California, Los Angeles
Investigators
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Principal Investigator: Thuy Doan, MD, PhD University of California, San Francisco
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Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT05286203    
Other Study ID Numbers: P0555674
First Posted: March 18, 2022    Key Record Dates
Last Update Posted: May 12, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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
Keywords provided by University of California, San Francisco:
Uveitis
Metagenomic deep sequencing
Intraocular infection
MDS
Additional relevant MeSH terms:
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Communicable Diseases
Infections
Uveitis
Disease Attributes
Pathologic Processes
Uveal Diseases
Eye Diseases