An interventional study of Metagenomic Deep Sequencing (MDS) and Standard of Care (SOC) in Uveitis and Infectious Disease, sponsored by University of California, San Francisco. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-26.
Sponsored by University of California, San Francisco · Not applicable, Interventional, and Diagnostic
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.
299 studies on the registry are indexed under Uveitis; 32 are open to participants now.
This study's enrollment of 100 is above the median of 30 across 175 interventional studies indexed under Uveitis.
Browse Uveitis studies →University of California, San Francisco is the lead sponsor of 2,169 studies on the registry; 372 are open to participants now.
Of its 267 completed or terminated interventional studies of FDA-regulated products, 202 (76%) have results posted.
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Exclusion Criteria:
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)
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.
SOC includes any available diagnostic tests, such as Gram stain, cultures, PCRs, that are considered the appropriate testing based on the clinical findings.
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
Time frame: 4-week after randomization
Appropriate Therapy
Dichotomous variable (Y/N) as determined by an independent expert panel
Time frame: 4-week after randomization
Provider Certainty of Belief
Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%, 0% signifying uncertain and 100% signifying certain)
Time frame: 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)
Time frame: 4-week after randomization
Comparative Sensitivity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis
Latent Class Analysis (LCA) was used to estimate the sensitivity of three diagnostic approaches: (1) clinical diagnosis by the treating physician at presentation, (2) conventional diagnostics, and (3) MDS. LCA was performed on all randomized participants with infection status, evaluating the diagnostic performance of treating physicians, conventional diagnostics, and MDS. A total of 100 participants were enrolled in Phase l of the OPTICS trial.
Time frame: Conclusion of study. 4 weeks after randomization.
Comparative Specificity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis
Latent Class Analysis (LCA) was used to estimate the specificity of three diagnostic approaches: (1) clinical diagnosis by the treating physician at presentation, (2) conventional diagnostics, and (3) MDS. LCA was performed on all randomized participants with infection status, evaluating the diagnostic performance of treating physicians, conventional diagnostics, and MDS. A total of 100 participants were enrolled in Phase l of the OPTICS trial.
Time frame: Conclusion of study. 4 weeks after randomization
Participants with presumed intraocular infection were enrolled at 6 sites: University of California, San Francisco; University of California, Los Angeles; University of California, Davis; University of Utah; University of Nebraska Medical Center; Khon Kaen University. Recruitment took place from May 2022 through January 2024.
| Milestone | Phase I | Phase II: Standard of Care | Phase ll: Metagenomic Deep Sequencing (MDS) Testing |
|---|---|---|---|
| Started | 100 | 0 | 0 |
| Completed | 92 | 0 | 0 |
| Not completed | 8 | 0 | 0 |
| Withdrew: Lost to follow-up | 8 | 0 | 0 |
| Milestone | Phase I | Phase II: Standard of Care | Phase ll: Metagenomic Deep Sequencing (MDS) Testing |
|---|---|---|---|
| Started | 0 | 12 | 9 |
| Completed | 0 | 11 | 9 |
| Not completed | 0 | 1 | 0 |
| Withdrew: Lost to follow-up | 0 | 1 | 0 |
Dichotomous variable (Y/N) as assessed by a masked evaluator
| Participants | Standard of Care | Metagenomic Deep Sequencing (MDS) Testing |
|---|---|---|
| Clinical Improvement | 7 | 8 |
| No Clinical Improvement | 4 | 1 |
Dichotomous variable (Y/N) as determined by an independent expert panel
| Participants | Standard of Care | Metagenomic Deep Sequencing (MDS) Testing |
|---|---|---|
| Appropriate Treatment | 11 | 8 |
| Not Appropriate Treatment | 0 | 1 |
Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%, 0% signifying uncertain and 100% signifying certain)
| Percent | Standard of Care | Metagenomic Deep Sequencing (MDS) Testing |
|---|---|---|
| Provider Certainty of Belief | 57.5 (31 to 78.75) | 95 (80 to 99) |
As measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)
| Quality of Life composite score | Standard of Care | Metagenomic Deep Sequencing (MDS) Testing |
|---|---|---|
| Patient Quality of Life | 62.8 (54.90 to 75.44) | 75.6 (50.83 to 85.69) |
Latent Class Analysis (LCA) was used to estimate the sensitivity of three diagnostic approaches: (1) clinical diagnosis by the treating physician at presentation, (2) conventional diagnostics, and (3) MDS. LCA was performed on all randomized participants with infection status, evaluating the diagnostic performance of treating physicians, conventional diagnostics, and MDS. A total of 100 participants were enrolled in Phase l of the OPTICS trial.
| Percentage of Cases | Clinician's Assessment | Conventional Diagnostics | Metagenomic Deep Sequencing |
|---|---|---|---|
| Comparative Sensitivity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis | 95.79 (84.31 to 100) | 53.17 (31.89 to 100) | 77.88 (53.84 to 100) |
Latent Class Analysis (LCA) was used to estimate the specificity of three diagnostic approaches: (1) clinical diagnosis by the treating physician at presentation, (2) conventional diagnostics, and (3) MDS. LCA was performed on all randomized participants with infection status, evaluating the diagnostic performance of treating physicians, conventional diagnostics, and MDS. A total of 100 participants were enrolled in Phase l of the OPTICS trial.
| Percentage of Cases | Clinician's Assessment | Conventional Diagnostics | Metagenomic Deep Sequencing |
|---|---|---|---|
| Comparative Specificity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis | 37.90 (23.07 to 56.90) | 96.82 (86.43 to 100) | 89.29 (71.87 to 100) |
Collected over From enrollment until end of follow-up, 4 weeks after randomization.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Phase l | 0/100 (0%) | 0/100 (0%) | 0/100 (0%) |
| Phase ll: Standard of Care | 0/12 (0%) | 0/12 (0%) | 0/12 (0%) |
| Phase ll: Metagenomic Deep Sequencing (MDS) Testing | 0/9 (0%) | 0/9 (0%) | 0/9 (0%) |
Of the 21 patients that proceeded to Phase II of the study, 9 were randomized to receive MDS results and 12 were randomized to not receive MDS results.
| Age, Continuous(years) | Phase I |
|---|---|
| Median | 62.0 (47.5 to 71.0) |
| Sex: Female, Male(Participants) | Phase I |
|---|---|
| Female | 57 |
| Male | 43 |
| Race/Ethnicity, Customized(Participants) | Phase I |
|---|---|
| Asian | 26 |
| African American, African, or Afro-Caribbean | 9 |
| Caucasian | 45 |
| Hispanic ethnicity | 21 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Jun 2022 to primary completion in Jan 2024, 19 months.
Results were first posted in Jun 2026, 2 years 4 months after primary completion.
Of 16 interventional studies with no phase under Uveitis, half reached primary completion within 27 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 49. This study's 19 months is below that.
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This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.
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