Trial · NCT05066230
A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
NCT05066230, Phase 3, Terminated, Kodiak Sciences Inc; results first posted 2024-09-05
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR). Trials, record NCT05066230. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05066230
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of Intravitreal KSI-301 in Non-proliferative Diabetic Retinopathy (NPDR)
- NCT number
- NCT05066230
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 253 participants, actual
- Lead sponsor
- Kodiak Sciences Inc
- Conditions
- Non-proliferative Diabetic Retinopathy
- Interventions
- KSI-301, Sham injection
- First posted
- 2021-10-04
- Last updated
- 2024-09-05
- Results first posted
- 2024-09-05
Source ClinicalTrials.gov
Registered outcomes15
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Patients Improving ≥2 Steps on DRSS | Day 1 to Week 48 | 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). |
| Secondary | Percentage of Patients Developing Any Sight-Threatening Complication | Day 1 to Week 48 | Percentage of patients developing any of the following Sight-Threatening Complication: Proliferative Diabetic Retinopathy (PDR), Anterior segment neovascularization (ASNV), Vitreous hemorrhage or tractional retinal detachment believed to be due to PDR, or Diabetic Macular Edema (DME) from baseline through Week 48 |
| Secondary | Percentage of Patients Improving ≥3 Steps on DRSS | Day 1 to Week 48 | Percentage of patients improving ≥3 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). |
| Secondary | Percentage of Patients Developing PDR | Day 1 to Week 48 | Percentage of patients developing Proliferative Diabetic Retinopathy (PDR) from baseline through Week 48 |
| Secondary | Percentage of Patients Developing PDR or ASNV | Day 1 to Week 48 | Percentage of patients developing Proliferative Diabetic Retinopathy (PDR) or Anterior segment neovascularization (ASNV) from baseline through Week 48 |
| Secondary | Percentage of Patients Developing Vitreous Hemorrhage or Tractional Retinal Detachment Believed to be Due to PDR | Day 1 to Week 48 | Percentage of patients developing vitreous hemorrhage or tractional retinal detachment believed to be due to Proliferative Diabetic Retinopathy (PDR) from baseline through Week 48 |
| Secondary | Percentage of Patients Developing DME | Day 1 to Week 48 | Percentage of patients developing Diabetic Macular Edema (DME) from baseline through Week 48 |
| Secondary | Percentage of Patients With a ≥2-step or ≥3-step Worsening on DRSS | Day 1 to Week 48 | Percentage of patients with a ≥2-step or ≥3-step worsening 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). |
| Secondary | Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA | Day 1 to Week 48 | Percentage of patients who lost ≥5, ≥10, or ≥15 letters in Best-corrected Visual Acuity (BCVA) from baseline by visit over time. Best Corrected Visual Acuity (BCVA) was measured on the Early Treatment Diabetic Retinopathy Study (ETDRS) chart at a starting distance of 4 meters. The BCVA letter score ranges from 0 to 100 (best score), and a gain in BCVA letter score from baseline indicates an improvement in visual acuity. |
| Secondary | Time to First Development of PDR, ASNV, or DME | Day 1 to Week 48 | Time to first development of Proliferative Diabetic Retinopathy (PDR), Anterior segment neovascularization (ASNV), or Diabetic Macular Edema (DME) through Week 48 |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 registered outcomesOutcomes15
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Patients Improving ≥2 Steps on DRSS | Day 1 to Week 48 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Developing Any Sight-Threatening Complication | Day 1 to Week 48 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Improving ≥3 Steps on DRSS | Day 1 to Week 48 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Developing PDR | Day 1 to Week 48 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Developing PDR or ASNV | Day 1 to Week 48 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Developing Vitreous Hemorrhage or Tractional Retinal Detachment Believed to be Due to PDR | Day 1 to Week 48 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Developing DME | Day 1 to Week 48 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients With a ≥2-step or ≥3-step Worsening on DRSS | Day 1 to Week 48 | 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. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients Who Lost ≥5, ≥10, or ≥15 Letters in BCVA | Day 1 to Week 48 | 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. The Overall Number of Participants Analyzed were 128 and 125, but the number analyzed for each row is different depending on the number of participants with data for that row. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Time to First Development of PDR, ASNV, or DME | Day 1 to Week 48 | 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. Subjects who did not have an event were censored at the date of the last scheduled study visit at or prior to Week 48. | Months | MEDIAN |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 outcomesResults by group76
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Patients Improving ≥2 Steps on DRSS | KSI-301 - Treatment Group A | 52 | Participants | ||
| Percentage of Patients Improving ≥2 Steps on DRSS | Treatment Group B | 2 | Participants | ||
| Percentage of Patients Developing Any Sight-Threatening Complication | KSI-301 - Treatment Group A | 3 | Participants | ||
| Percentage of Patients Developing Any Sight-Threatening Complication | Treatment Group B | 26 | Participants | ||
| Percentage of Patients Improving ≥3 Steps on DRSS | KSI-301 - Treatment Group A | 7 | Participants | ||
| Percentage of Patients Improving ≥3 Steps on DRSS | Treatment Group B | 0 | Participants | ||
| Percentage of Patients Developing PDR | KSI-301 - Treatment Group A | 2 | Participants | ||
| Percentage of Patients Developing PDR | Treatment Group B | 10 | Participants | ||
| Percentage of Patients Developing PDR or ASNV | KSI-301 - Treatment Group A | 2 | Participants | ||
| Percentage of Patients Developing PDR or ASNV | Treatment Group B | 10 | Participants |
1 to 10 of 76Source ClinicalTrials.gov
See all 76 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Study (Through Week 48) | STARTED | KSI-301 - Treatment Group A | 128 | |
| Primary Study (Through Week 48) | STARTED | Treatment Group B | 125 | |
| Primary Study (Through Week 48) | COMPLETED | KSI-301 - Treatment Group A | 120 | |
| Primary Study (Through Week 48) | COMPLETED | Treatment Group B | 115 | |
| Primary Study (Through Week 48) | NOT COMPLETED | KSI-301 - Treatment Group A | 8 | |
| Primary Study (Through Week 48) | NOT COMPLETED | Treatment Group B | 10 | |
| After Week 48 | STARTED | KSI-301 - Treatment Group A | 120 | |
| After Week 48 | STARTED | Treatment Group B | 115 | |
| After Week 48 | COMPLETED | KSI-301 - Treatment Group A | 0 | |
| After Week 48 | COMPLETED | Treatment Group B | 0 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events220
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Cataract - Study Eye | Eye disorders | KSI-301 - Treatment Group A (Day 1 to Week 48) | 13 | 128 | 14 |
| other | Cataract - Study Eye | Eye disorders | Treatment Group B (Day 1 to Week 48) | 5 | 125 | 5 |
| other | Cataract - Study Eye | Eye disorders | KSI-301 - Treatment Group A (Post Week 48 to End of Study) | 3 | 120 | 3 |
| other | Cataract - Study Eye | Eye disorders | Treatment Group B (Post Week 48 to End of Study) | 0 | 115 | 0 |
| other | Conjunctival haemorrhage - Study Eye | Eye disorders | KSI-301 - Treatment Group A (Day 1 to Week 48) | 9 | 128 | 9 |
| other | Conjunctival haemorrhage - Study Eye | Eye disorders | Treatment Group B (Day 1 to Week 48) | 4 | 125 | 5 |
| other | Conjunctival haemorrhage - Study Eye | Eye disorders | KSI-301 - Treatment Group A (Post Week 48 to End of Study) | 1 | 120 | 1 |
| other | Conjunctival haemorrhage - Study Eye | Eye disorders | Treatment Group B (Post Week 48 to End of Study) | 0 | 115 | 0 |
| other | Cataract - Fellow Eye | Eye disorders | KSI-301 - Treatment Group A (Day 1 to Week 48) | 7 | 128 | 7 |
| other | Cataract - Fellow Eye | Eye disorders | Treatment Group B (Day 1 to Week 48) | 3 | 125 | 3 |
1 to 10 of 220Source ClinicalTrials.gov
See all 220 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KSI-301 - Treatment Group A (Day 1 to Week 48) | 1 | 128 |
| Total, all-cause mortality | Treatment Group B (Day 1 to Week 48) | 1 | 125 |
| Total, all-cause mortality | KSI-301 - Treatment Group A (Post Week 48 to End of Study) | 1 | 120 |
| Total, all-cause mortality | Treatment Group B (Post Week 48 to End of Study) | 0 | 115 |
| Total, other adverse events | KSI-301 - Treatment Group A (Day 1 to Week 48) | 49 | 128 |
| Total, other adverse events | Treatment Group B (Day 1 to Week 48) | 51 | 125 |
| Total, other adverse events | KSI-301 - Treatment Group A (Post Week 48 to End of Study) | 15 | 120 |
| Total, other adverse events | Treatment Group B (Post Week 48 to End of Study) | 9 | 115 |
| Total, serious adverse events | KSI-301 - Treatment Group A (Day 1 to Week 48) | 18 | 128 |
| Total, serious adverse events | Treatment Group B (Day 1 to Week 48) | 12 | 125 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons7
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| KSI-301 - Treatment Group A vs Treatment Group B: Percentage of Patients Developing PDR or ASNV | Trial comparisons |
| KSI-301 - Treatment Group A vs Treatment Group B: Percentage of Patients Developing Vitreous Hemorrhage or Tractional Retinal Detachment Believed to be Due to PDR | Trial comparisons |
| KSI-301 - Treatment Group A vs Treatment Group B: Percentage of Patients Improving ≥2 Steps on DRSS | Trial comparisons |
| KSI-301 - Treatment Group A vs Treatment Group B: Percentage of Patients Developing DME | Trial comparisons |
| KSI-301 - Treatment Group A vs Treatment Group B: Percentage of Patients Improving ≥3 Steps on DRSS | Trial comparisons |
| KSI-301 - Treatment Group A vs Treatment Group B: Percentage of Patients Developing Any Sight-Threatening Complication | Trial comparisons |
| KSI-301 - Treatment Group A vs Treatment Group B: Percentage of Patients Developing PDR | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
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
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05066230
GET https://conductscience.org/api/trials/v1/NCT05066230/results?page=2