Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing

NCT05286203 | Completed Results DMC FDA Device

• 1 other identifier: P0555674
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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.

Conditions

Uveitis; Infectious Disease

Keywords

Uveitis; Metagenomic deep sequencing; Intraocular infection; MDS

Outcome Measures

Primary Outcomes (2)

• Clinical Improvement 2-step Decrease in the Level of Inflammation or Decrease to Grade 0; Inflammatory Retinal/Choroidal Lesions Reducing in Size; 20% Improvement of CST on Optical Coherence Tomography, a > 10- Letter Improvement in Visual Acuity,

  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 Outcomes (4)

• Provider Certainty of Belief

  4-week after randomization

• Patient Quality of Life

  4-week after randomization

• Comparative Sensitivity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis

  Conclusion of study. 4 weeks after randomization.

• Comparative Specificity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis

  Conclusion of study. 4 weeks after randomization

Study Arms (2)

Standard of Care

ACTIVE COMPARATOR

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)

MDS

EXPERIMENTAL

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)

Interventions

Metagenomic Deep Sequencing (MDS) DEVICE

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.

MDS

Standard of Care (SOC) DIAGNOSTIC_TEST

SOC includes any available diagnostic tests, such as Gram stain, cultures, PCRs, that are considered the appropriate testing based on the clinical findings.

Standard of Care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Presumed infectious anterior uveitis, or intermediate uveitis, or posterior uveitis, or panuveitis
• Presumed post-operative endophthalmitis
• Unilateral or bilateral
• years and older

You may not qualify if:

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

Sponsors & Collaborators

• University of California, San Francisco: lead
• University of Nebraska: collaborator
• University of Utah: collaborator
• University of California, Davis: collaborator
• University of California, Los Angeles: collaborator
• Research to Prevent Blindness: collaborator

Study Sites (1)

University of California San Francisco (UCSF)

San Francisco, California, 94158, United States

Location

Related Publications (1)

• Shantha JG, Moussa K, Laovirojjanakul W, Yeh S, Tsui E, Chen JL, Vitale AT, Shakoor A, Larochelle M, Niemeyer K, Mentreddy A, Livnat I, Safo M, Ao W, Choo C, Yan D, Zhong L, Chen C, Da Silva K, Reddy AK, Lee J, Sura A, Crowell EL, Qian Y, Sharon Y, Hinterwirth A, Porco T, Arnold BF, Gonzales J, Acharya NR, Lietman TM, Doan T; OPTICS Study Group. The Effect of Metagenomic Sequencing on Patient Clinical Outcomes for Intraocular Infections: A Multicenter Randomized Controlled Trial. Am J Ophthalmol. 2025 Nov;279:100-109. doi: 10.1016/j.ajo.2025.07.003. Epub 2025 Jul 11.

  PMID: 40653257 DERIVED

MeSH Terms

Conditions

Uveitis; Communicable Diseases

Condition Hierarchy (Ancestors)

Uveal Diseases; Eye Diseases; Infections; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

79% of patients did not proceed to randomization. Participants were predominantly recruited in the U.S. and thus limited study interpretations to other geographic areas. Only patients with presumed infectious intraocular inflammation were assessed - the use of MDS for other types of ocular infections may require a different trial. Lastly, uveitis is a heterogeneous group of inflammatory diseases which can make clinical outcome assessment difficult when designing clinical trials.

Results Point of Contact

• Title: Thuy Doan
• Organization: UCSF F. I. Proctor Foundation

thuy.doan@ucsf.edu

415-476-6939

Study Officials

• Thuy Doan, MD, PhD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 23, 2022
• First Posted: March 18, 2022
• Study Start: June 6, 2022
• Primary Completion: January 31, 2024
• Study Completion: February 28, 2024
• Last Updated: June 26, 2026
• Results First Posted: June 26, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)