Comparison · NCT05066230-a4dbb110
KSI-301 - Treatment Group A vs Treatment Group B: Percentage of Patients Developing PDR
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
2 sourcestrial-comparisons-2026-03-23-0.1.0
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ConductScience Library. KSI-301 - Treatment Group A vs Treatment Group B: Percentage of Patients Developing PDR. Trial comparisons, record NCT05066230-a4dbb110. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05066230-a4dbb110
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Measures6
Calculated by ConductScience from the counts the trial posted to ClinicalTrials.gov.
| Measure | Value | 95% interval, lower | 95% interval, upper | Method | Note |
|---|---|---|---|---|---|
| Risk in group 1 | 0.0156 | 0.0043 | 0.0552 | wilson | |
| Risk in group 2 | 0.08 | 0.044 | 0.141 | wilson | |
| Risk difference, group 1 minus group 2 | -0.0644 | -0.126 | -0.0109 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 0.195 | 0.0437 | 0.874 | log | |
| Odds ratio, group 1 over group 2 | 0.183 | 0.0392 | 0.851 | log | |
| Number needed to treat, for one fewer participant with the outcome on KSI-301 - Treatment Group A than on Treatment Group B | 15.5 | 7.91 | 91.6 | from the risk difference interval |
Source ClinicalTrials.gov
Groups2
Neither group, or both, names a comparator, so the groups keep ClinicalTrials.gov's order.
| Group | Title | Description | With the outcome | Analysed | ClinicalTrials.gov code |
|---|---|---|---|---|---|
| Group 1 | KSI-301 - Treatment Group A | Intravitreal injection of KSI-301 (5 mg): three initiating doses, and then every 24 weeks through Week 92~KSI-301: Intravitreal injection | 2 | 128 | OG000 |
| Group 2 | Treatment Group B | Sham injection on the same schedule as Treatment Group A~Sham injection: The sham injection is a procedure that mimics an intravitreal injection. It involves pressing the blunt end of an empty syringe (without a needle) against the anesthetized eye. It is performed to maintain masking of the study. | 10 | 125 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- SECONDARY
- Title
- Percentage of Patients Developing PDR
- Description
- Percentage of patients developing Proliferative Diabetic Retinopathy (PDR) from baseline through Week 48
- Time frame
- Day 1 to Week 48
- Population
Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or sham) and have gradable DRSS value at baseline. Subjects will be analyzed according to their randomized treatment.
Source ClinicalTrials.gov
Trial
- Title
- A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
- NCT number
- NCT05066230
- Phases
- PHASE3
- Conditions
- Non-proliferative Diabetic Retinopathy
- Interventions
- KSI-301, Sham injection
- Lead sponsor
- Kodiak Sciences Inc
- Results first posted
- 2024-09-05
- Results on ClinicalTrials.gov
- https://clinicaltrials.gov/study/NCT05066230?tab=results
Source ClinicalTrials.gov
Source
- Release
- trial-comparisons-2026-03-23-0.1.0
- Release manifest SHA-256
- f66225897fbf258b57ea10bdacfd0347d3cdfda93f7f5685234b7e06ea36fa57
- AACT copy
- 2026-03-23
- Tables read
- outcome_counts.parquet, outcome_measurements.parquet, outcomes.parquet, reported_event_totals.parquet, reported_events.parquet, result_groups.parquet, studies.parquet, ctgov_trial.parquet
Source ClinicalTrials.gov
Sources 2
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions. The measures are ConductScience's calculation from them.
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