Comparison · NCT05066230-58a2de0f
KSI-301 - Treatment Group A vs Treatment Group B: Percentage of Patients Improving ≥2 Steps on DRSS
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 Improving ≥2 Steps on DRSS. Trial comparisons, record NCT05066230-58a2de0f. Release trial-comparisons-2026-03-23-0.1.0, 23 Mar 2026. https://conductscience.org/library/comparisons/NCT05066230-58a2de0f
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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 | 0.406 | 0.325 | 0.493 | wilson | |
| Risk in group 2 | 0.016 | 0.0044 | 0.0565 | wilson | |
| Risk difference, group 1 minus group 2 | 0.39 | 0.3 | 0.478 | newcombe hybrid score | |
| Risk ratio, group 1 over group 2 | 25.4 | 6.32 | 102 | log | |
| Odds ratio, group 1 over group 2 | 42.1 | 9.96 | 178 | log | |
| Number needed to treat, for one more participant with the outcome on KSI-301 - Treatment Group A than on Treatment Group B | 2.56 | 2.09 | 3.34 | 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 | 52 | 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. | 2 | 125 | OG001 |
Source ClinicalTrials.gov
Outcome
- Type
- PRIMARY
- Title
- Percentage of Patients Improving ≥2 Steps on DRSS
- Description
Percentage of patients improving ≥2 steps on the Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 48 using last observation carried forward (LOCF). The Diabetic Retinopathy Disease Severity Scale (DRSS) may be used to describe overall retinopathy severity as well as the change in severity over time. Severity range from level 10 (DR absent) to level 85 (advanced proliferative DR: posterior fundus obscured, or center of macula detached).
- 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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