Trial Outcomes & Findings for Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing (NCT NCT05286203)
NCT ID: NCT05286203
Last Updated: 2026-06-26
Results Overview
Dichotomous variable (Y/N) as assessed by a masked evaluator
COMPLETED
NA
100 participants
4-week after randomization
2026-06-26
Participant Flow
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.
The trial involved two phases with two distinct inclusion criteria. Participants moved onto phase II, where they were randomized to two arms, if they met the following inclusion criteria: active inflammation in at least one eye and/or active retinal or choroidal inflammation and/or macular edema. Participants were excluded from randomization if: pathogen identified that was consistent with clinical findings, complete resolution of inflammation, or no light perception (NLP) vision.
Participant milestones
| Measure |
Phase I
Patients enrolled with presumed infectious inflammatory eye disease.
|
Phase II: Standard of Care
Patients enrolled in the trial and randomized to the standard of care testing arm.
|
Phase ll: Metagenomic Deep Sequencing (MDS) Testing
Patients enrolled in the trial and randomized to the MDS arm.
|
|---|---|---|---|
|
Phase 1
STARTED
|
100
|
0
|
0
|
|
Phase 1
COMPLETED
|
92
|
0
|
0
|
|
Phase 1
NOT COMPLETED
|
8
|
0
|
0
|
|
Phase 2
STARTED
|
0
|
12
|
9
|
|
Phase 2
COMPLETED
|
0
|
11
|
9
|
|
Phase 2
NOT COMPLETED
|
0
|
1
|
0
|
Reasons for withdrawal
| Measure |
Phase I
Patients enrolled with presumed infectious inflammatory eye disease.
|
Phase II: Standard of Care
Patients enrolled in the trial and randomized to the standard of care testing arm.
|
Phase ll: Metagenomic Deep Sequencing (MDS) Testing
Patients enrolled in the trial and randomized to the MDS arm.
|
|---|---|---|---|
|
Phase 1
Lost to Follow-up
|
8
|
0
|
0
|
|
Phase 2
Lost to Follow-up
|
0
|
1
|
0
|
Baseline Characteristics
Ocular Pathogen and Transcriptome Investigation Using Comprehensive Sequencing
Baseline characteristics by cohort
| Measure |
Phase I
n=100 Participants
Patients enrolled into Phase I.
|
|---|---|
|
Age, Continuous
|
62.0 years
n=20 Participants
|
|
Sex: Female, Male
Female
|
57 Participants
n=20 Participants
|
|
Sex: Female, Male
Male
|
43 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Asian
|
26 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
African American, African, or Afro-Caribbean
|
9 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Caucasian
|
45 Participants
n=20 Participants
|
|
Race/Ethnicity, Customized
Hispanic ethnicity
|
21 Participants
n=20 Participants
|
PRIMARY outcome
Timeframe: 4-week after randomizationPopulation: One participant in the Standard of Care group was lost to follow-up post randomization.
Dichotomous variable (Y/N) as assessed by a masked evaluator
Outcome measures
| Measure |
Standard of Care
n=11 Participants
Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.
|
Metagenomic Deep Sequencing (MDS) Testing
n=9 Participants
Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.
|
Metagenomic Deep Sequencing
The outcome of this LCA is the sensitivity of the Metagenomic Deep Sequencing (MDS). There are no p-values involved.
|
|---|---|---|---|
|
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,
Clinical Improvement
|
7 Participants
|
8 Participants
|
—
|
|
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,
No Clinical Improvement
|
4 Participants
|
1 Participants
|
—
|
PRIMARY outcome
Timeframe: 4-week after randomizationPopulation: One participant in the Standard of Care group was lost to follow-up post randomization.
Dichotomous variable (Y/N) as determined by an independent expert panel
Outcome measures
| Measure |
Standard of Care
n=11 Participants
Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.
|
Metagenomic Deep Sequencing (MDS) Testing
n=9 Participants
Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.
|
Metagenomic Deep Sequencing
The outcome of this LCA is the sensitivity of the Metagenomic Deep Sequencing (MDS). There are no p-values involved.
|
|---|---|---|---|
|
Appropriate Therapy
Appropriate Treatment
|
11 Participants
|
8 Participants
|
—
|
|
Appropriate Therapy
Not Appropriate Treatment
|
0 Participants
|
1 Participants
|
—
|
SECONDARY outcome
Timeframe: 4-week after randomizationPopulation: One participant in the Standard of Care group was lost to follow-up post randomization.
Provider certainty of belief that the patient has an infection (continuous variable from 0 to 100%, 0% signifying uncertain and 100% signifying certain)
Outcome measures
| Measure |
Standard of Care
n=11 Participants
Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.
|
Metagenomic Deep Sequencing (MDS) Testing
n=9 Participants
Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.
|
Metagenomic Deep Sequencing
The outcome of this LCA is the sensitivity of the Metagenomic Deep Sequencing (MDS). There are no p-values involved.
|
|---|---|---|---|
|
Provider Certainty of Belief
|
57.5 Percent
Interval 31.0 to 78.75
|
95 Percent
Interval 80.0 to 99.0
|
—
|
SECONDARY outcome
Timeframe: 4-week after randomizationAs measured by National Eye Institute Vision Function Questionnaire (min = 0, max = 100; higher means better vision function)
Outcome measures
| Measure |
Standard of Care
n=11 Participants
Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.
|
Metagenomic Deep Sequencing (MDS) Testing
n=9 Participants
Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.
|
Metagenomic Deep Sequencing
The outcome of this LCA is the sensitivity of the Metagenomic Deep Sequencing (MDS). There are no p-values involved.
|
|---|---|---|---|
|
Patient Quality of Life
|
62.8 Quality of Life composite score
Interval 54.9 to 75.44
|
75.6 Quality of Life composite score
Interval 50.83 to 85.69
|
—
|
SECONDARY outcome
Timeframe: Conclusion of study. 4 weeks after randomization.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.
Outcome measures
| Measure |
Standard of Care
n=100 Participants
Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.
|
Metagenomic Deep Sequencing (MDS) Testing
n=100 Participants
Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.
|
Metagenomic Deep Sequencing
n=100 Participants
The outcome of this LCA is the sensitivity of the Metagenomic Deep Sequencing (MDS). There are no p-values involved.
|
|---|---|---|---|
|
Comparative Sensitivity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis
|
95.79 Percentage of Cases
Interval 84.31 to 100.0
|
53.17 Percentage of Cases
Interval 31.89 to 100.0
|
77.88 Percentage of Cases
Interval 53.84 to 100.0
|
SECONDARY outcome
Timeframe: Conclusion of study. 4 weeks after randomizationLatent 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.
Outcome measures
| Measure |
Standard of Care
n=100 Participants
Patients enrolled in the trial and randomized to the standard of care (SOC) arm will undergo standard of care testing.
|
Metagenomic Deep Sequencing (MDS) Testing
n=100 Participants
Patients enrolled in the trial and randomized to the MDS arm will undergo standard of care testing and MDS testing.
|
Metagenomic Deep Sequencing
n=100 Participants
The outcome of this LCA is the sensitivity of the Metagenomic Deep Sequencing (MDS). There are no p-values involved.
|
|---|---|---|---|
|
Comparative Specificity of the Physician, Conventional Diagnostics, and MDS Using Latent Class Analysis
|
37.90 Percentage of Cases
Interval 23.07 to 56.9
|
96.82 Percentage of Cases
Interval 86.43 to 100.0
|
89.29 Percentage of Cases
Interval 71.87 to 100.0
|
Adverse Events
Phase l
Phase ll: Standard of Care
Phase ll: Metagenomic Deep Sequencing (MDS) Testing
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place