Trial · NCT04592419
A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
NCT04592419, Phase 3, Completed, Kodiak Sciences Inc; results first posted 2024-06-06
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO). Trials, record NCT04592419. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04592419
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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, Durability, and Safety of KSI-301 Compared to Aflibercept in Patients With Macular Edema Due to Retinal Vein Occlusion (RVO)
- NCT number
- NCT04592419
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 568 participants, actual
- Lead sponsor
- Kodiak Sciences Inc
- Conditions
- Macular Edema, Retinal Vein Occlusion
- Interventions
- KSI-301, Aflibercept, Sham Procedure
- First posted
- 2020-10-19
- Last updated
- 2024-06-26
- Other registries' IDs
- eudract:2020-001061-37
- Results first posted
- 2024-06-06
Source ClinicalTrials.gov
Registered outcomes10
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. | Day 1 to Week 24 | BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach. |
| Primary | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients. | Day 1 to Week 24 | BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach. |
| Secondary | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Day 1 - Week 48 | BCVA as a continuous variable measured at each study visit using the Early Treatment Diabetic Retinopathy Study (ETDRS) BCVA approach. |
| Secondary | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Day 1 - Week 48 | Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100\*n/N. |
| Secondary | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Day 1 - Week 48 | Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100\*n/N. |
| Secondary | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Day 1 - Week 48. | Percentage of participants with BCVA Snellen Equivalent of 20/40 or Better from Baseline to Week 48. Snellen Equivalent of 20/40 is 69 ETDRS letters. Number of participants in each treatment arm who meet specified criteria at each visit from Baseline through Week 48. Percentages are 100\*n/N. |
| Secondary | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Baseline - Week 48 | Percentage of Participants with BCVA Snellen Equivalent of 20/200 or Worse from Baseline to Week 48. Snellen Equivalent of 20/200 is 38 ETDRS letters. Number of participants in each treatment arm who meet specified criteria at each visit from Baseline through Week 48. Percentages are 100\*n/N. |
| Secondary | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Baseline - Week 48 | Macular Edema (ME) is assessed by optical coherence tomography (OCT) central subfield thickness (CST). A thickness of less than 325 microns is considered absence of ME. Proportion of participants with Absence of Macular Edema from Baseline to Week 48. Number of participants in each treatment arm who meet specified criteria at each visit from Week 1 through Week 48. Percentages are 100\*n/N. |
| Secondary | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Day 1 - Week 48 | Mean change in OCT central subfield retinal thickness (CST) from baseline by visit over time (up to Week 48) for all RVO participants. |
| Secondary | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Day 1 - Week 48 | Mean change in OCT center point retinal thickness (CPT) from baseline by visit over time (up to Week 48) for all RVO participants. |
Source ClinicalTrials.gov
Outcomes10
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. | Day 1 to Week 24 | Full Analysis Set (Week 24) includes all randomized participants who received at least one treatment injection in the first 24 weeks and using all available post baseline measurements up to Week 24 or until the participant discontinues study treatment. | ETDRS Letters | LEAST_SQUARES_MEAN |
| PRIMARY | Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients. | Day 1 to Week 24 | Full Analysis Set (Week 24) includes all randomized subjects who received at least one treatment injection in the first 24 weeks and using all available post baseline measurements up to Week 24 or until the subject discontinues study treatment. | ETDRS Letters | LEAST_SQUARES_MEAN |
| SECONDARY | Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Day 1 - Week 48 | Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit. | ETDRS Letters | MEAN |
| SECONDARY | Percentage of Participants Who Gain ≥ 5, ≥10 and ≥15 Letters From Baseline Over Time up to Week 48 for All RVO Participants. | Day 1 - Week 48 | Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants Who Lose ≥ 5, ≥10 and ≥15 ETDRS Letters From Baseline Over Time up to Week 48 for All RVO Participants | Day 1 - Week 48 | Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With BCVA Snellen Equivalent of 20/40 or Better Over Time (≥69 ETDRS Letters) for All RVO Participants. | Day 1 - Week 48. | Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With BCVA Snellen Equivalent of 20/200 or Worse (≤ 38 ETDRS Letters) Over Time for All RVO Participants. | Baseline - Week 48 | Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Participants With Absence of Macular Edema (Defined as OCT CST < 325 Microns) Over Time for All RVO Participants. | Baseline - Week 48 | Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Change in OCT Central Subfield Retinal Thickness (CST) From Baseline by Visit Over Time for All RVO Participants. | Day 1 - Week 48 | Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit. | micrometers (um) | MEAN |
| SECONDARY | Mean Change in OCT Center Point Retinal Thickness (CPT) From Baseline by Visit Over Time for All RVO Participants. | Day 1 - Week 48 | Full Analysis Set (Week 24 or 48) includes all randomized participants who received at least one treatment injection in the first 24/48 weeks and using all available post baseline measurements up to Week 24/48 or until the participant discontinues study treatment. Number analyzed by visit is equal to the number of participants who had data available at that respective visit. | micrometers (um) | MEAN |
Source ClinicalTrials.gov
Results by group322
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. | KSI-301 (Arm A) | 14.2 | Standard Error .81 | ETDRS Letters | |
| Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in BRVO Participants. | Aflibercept (Arm B) | 15.6 | Standard Error .79 | ETDRS Letters | |
| Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients. | KSI-301 (Arm A) | 13.0 | Standard Error .83 | ETDRS Letters | |
| Mean Change in Best Corrected Visual Acuity (BCVA) From Day 1 to Week 24 in All RVO Patients. | Aflibercept (Arm B) | 15.5 | Standard Error .81 | ETDRS Letters | |
| Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | KSI-301 (Arm A) | Week 1 | 7.7 | Standard Deviation 9.25 | ETDRS Letters |
| Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Aflibercept (Arm B) | Week 1 | 7.9 | Standard Deviation 7.74 | ETDRS Letters |
| Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | KSI-301 (Arm A) | Week 4 | 8.9 | Standard Deviation 9.89 | ETDRS Letters |
| Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Aflibercept (Arm B) | Week 4 | 11.2 | Standard Deviation 10.01 | ETDRS Letters |
| Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | KSI-301 (Arm A) | Week 8 | 11.4 | Standard Deviation 10.38 | ETDRS Letters |
| Mean Change From Baseline in BCVA (ETDRS Letters) by Visit Over Time up to Week 48 for All RVO Participants. | Aflibercept (Arm B) | Week 8 | 13.5 | Standard Deviation 9.78 | ETDRS Letters |
1 to 10 of 322Source ClinicalTrials.gov
See all 322 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Primary Study (Through Year 1) | STARTED | KSI-301 (Arm A) | 284 | |
| Primary Study (Through Year 1) | STARTED | Aflibercept (Arm B) | 284 | |
| Primary Study (Through Year 1) | Completed Treatment at Week 20 | KSI-301 (Arm A) | 270 | |
| Primary Study (Through Year 1) | Completed Treatment at Week 20 | Aflibercept (Arm B) | 274 | |
| Primary Study (Through Year 1) | Did Not Discontinue Treatment Before Week 24 | KSI-301 (Arm A) | 270 | |
| Primary Study (Through Year 1) | Did Not Discontinue Treatment Before Week 24 | Aflibercept (Arm B) | 276 | |
| Primary Study (Through Year 1) | Did Not Discontinue Study Before Week 24 | KSI-301 (Arm A) | 275 | |
| Primary Study (Through Year 1) | Did Not Discontinue Study Before Week 24 | Aflibercept (Arm B) | 276 | |
| Primary Study (Through Year 1) | COMPLETED | KSI-301 (Arm A) | 255 | |
| Primary Study (Through Year 1) | COMPLETED | Aflibercept (Arm B) | 255 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events264
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 | Conjunctival haemorrhage - Study eye | Eye disorders | KSI-301 (Arm A) | 24 | 284 | 27 |
| other | Conjunctival haemorrhage - Study eye | Eye disorders | Aflibercept (Arm B) | 22 | 284 | 24 |
| other | Conjunctival haemorrhage - Study eye | Eye disorders | KSI-301 5mg Extension Phase | 8 | 444 | 8 |
| other | COVID-19 | Infections and infestations | KSI-301 (Arm A) | 30 | 284 | 30 |
| other | COVID-19 | Infections and infestations | Aflibercept (Arm B) | 23 | 284 | 23 |
| other | COVID-19 | Infections and infestations | KSI-301 5mg Extension Phase | 32 | 444 | 33 |
| other | Hypertension | Vascular disorders | KSI-301 (Arm A) | 30 | 284 | 31 |
| other | Hypertension | Vascular disorders | Aflibercept (Arm B) | 26 | 284 | 28 |
| other | Hypertension | Vascular disorders | KSI-301 5mg Extension Phase | 13 | 444 | 13 |
| serious | Atrial fibrillation | Cardiac disorders | KSI-301 (Arm A) | 2 | 284 | 3 |
1 to 10 of 264Source ClinicalTrials.gov
See all 264 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KSI-301 (Arm A) | 3 | 284 |
| Total, all-cause mortality | Aflibercept (Arm B) | 1 | 284 |
| Total, all-cause mortality | KSI-301 5mg Extension Phase | 2 | 444 |
| Total, other adverse events | KSI-301 (Arm A) | 73 | 284 |
| Total, other adverse events | Aflibercept (Arm B) | 66 | 284 |
| Total, other adverse events | KSI-301 5mg Extension Phase | 53 | 444 |
| Total, serious adverse events | KSI-301 (Arm A) | 36 | 284 |
| Total, serious adverse events | Aflibercept (Arm B) | 23 | 284 |
| Total, serious adverse events | KSI-301 5mg Extension Phase | 18 | 444 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 42054088 | DERIVED |
Source PubMed
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04592419
GET https://conductscience.org/api/trials/v1/NCT04592419/results?page=2