Trial · NCT04611152
A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
NCT04611152, Phase 3, Terminated, Kodiak Sciences Inc; results first posted 2024-08-22
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME). Trials, record NCT04611152. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04611152
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Trial to Evaluate the Efficacy, Durability, and Safety of KSI-301 Compared to Aflibercept in Participants With Diabetic Macular Edema (DME)
- NCT number
- NCT04611152
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 460 participants, actual
- Lead sponsor
- Kodiak Sciences Inc
- Conditions
- Diabetic Macular Edema
- Interventions
- KSI-301, Aflibercept, Sham Procedure
- First posted
- 2020-11-02
- Last updated
- 2024-08-22
- Other registries' IDs
- eudract:2020-001062-11
- Results first posted
- 2024-08-22
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Mean Change in BCVA | Day 1 to Week 64 | Mean change in best-corrected visual acuity (BCVA) from baseline to the average of Weeks 60 and 64 (using Early Treatment Diabetic Retinopathy Study (ETDRS) Letters). 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 | Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Studies KS301P104 and KS301P105 Combined | Day 1 to Week 52 | Percentage of patients with a ≥ 2-step worsening on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 52 using last observation carried forward (LOCF) in Studies KS301P104 and KS301P105 combined. 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 With a ≥ 2-step Worsening on the ETDRS DRSS in Study KS301P104 | Day 1 to Week 52 | Percentage of patients with a ≥ 2-step worsening on the Early Treatment Diabetic Retinopathy Study (ETDRS) Diabetic Retinopathy Severity Scale (DRSS) from baseline at Week 52 using last observation carried forward (LOCF) in Study KS301P104. 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 in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval | Week 56 | Percentage of patients in the KSI-301 arm on a Q8W, Q12W, Q16W, Q20W, or Q24W treatment interval at the primary endpoint. Analyses include KSI-301 patients who completed a treatment interval from Week 56 onwards. |
| Secondary | Mean Number of Intravitreal Injections | Day 1 to Week 60 | Mean number of intravitreal injections from Day 1 to Week 60 |
| Secondary | Mean Change in OCT CST | Day 1 to Week 64 | Mean change in Optical Coherence Tomography (OCT) central subfield retinal thickness (CST) from baseline to the average of Weeks 60 and 64 |
Source ClinicalTrials.gov
Outcomes6
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Mean Change in BCVA | Day 1 to Week 64 | Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or aflibercept). Subjects will be analyzed according to their randomized treatment. | ETDRS Letters | LEAST_SQUARES_MEAN |
| SECONDARY | Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Studies KS301P104 and KS301P105 Combined | Day 1 to Week 52 | All randomized subjects in Studies KS301P104 and KS301P105 who received any study treatment (KSI-301 or aflibercept) with evaluable results at baseline and evaluable results on or prior to Week 52. The population for studies KS301P104 and KS301P105 are identical in terms of treatment indication and inclusion/exclusion criteria. Please refer to NCT04603937 to review demographics, other study details and adverse events for participants in KS301P105 study. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Study KS301P104 | Day 1 to Week 52 | All randomized subjects who received any study treatment (KSI-301 or aflibercept) with evaluable results at baseline and evaluable results on or prior to Week 52. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval | Week 56 | Analyses include KSI-301 patients who completed a treatment interval from Week 56 onwards. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Mean Number of Intravitreal Injections | Day 1 to Week 60 | Safety Analysis Set includes all patients who received any study treatment (KSI-301 or aflibercept).~Patients will be analyzed according to the study treatment they actually received. | injections | MEAN |
| SECONDARY | Mean Change in OCT CST | Day 1 to Week 64 | Full analysis set defined as all randomized subjects who received any study treatment (KSI-301 or aflibercept). Subjects will be analyzed according to their randomized treatment. | Microns | MEAN |
Source ClinicalTrials.gov
Results by group15
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Mean Change in BCVA | KSI-301 (Arm A) | 5.6 | Standard Error 0.83 | ETDRS Letters | |
| Mean Change in BCVA | Aflibercept (Arm B) | 9.5 | Standard Error 0.85 | ETDRS Letters | |
| Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Studies KS301P104 and KS301P105 Combined | KSI-301 (Arm A) | 6 | Participants | ||
| Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Studies KS301P104 and KS301P105 Combined | Aflibercept (Arm B) | 3 | Participants | ||
| Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Study KS301P104 | KSI-301 (Arm A) | 0 | Participants | ||
| Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Study KS301P104 | Aflibercept (Arm B) | 0 | Participants | ||
| Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval | KSI-301 (Arm A) | Number of participants on the KSI-301 Q8W | 61 | Participants | |
| Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval | KSI-301 (Arm A) | Number of participants on the KSI-301 Q12W | 21 | Participants | |
| Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval | KSI-301 (Arm A) | Number of participants on the KSI-301 Q16W | 19 | Participants | |
| Percentage of Patients in the KSI-301 Arm on a Q8W, Q12W, Q16W, Q20W, or Q24W Treatment Interval | KSI-301 (Arm A) | Number of participants on the KSI-301 Q20W | 8 | Participants |
1 to 10 of 15Source ClinicalTrials.gov
See all 15 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | KSI-301 (Arm A) | 230 | |
| Overall Study | STARTED | Aflibercept (Arm B) | 230 | |
| Overall Study | COMPLETED | KSI-301 (Arm A) | 204 | |
| Overall Study | COMPLETED | Aflibercept (Arm B) | 211 | |
| Overall Study | NOT COMPLETED | KSI-301 (Arm A) | 26 | |
| Overall Study | NOT COMPLETED | Aflibercept (Arm B) | 19 |
Source ClinicalTrials.gov
Adverse events270
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 (Arm A) | 35 | 230 | 38 |
| other | Cataract - Study Eye | Eye disorders | Aflibercept (Arm B) | 17 | 230 | 17 |
| other | Diabetic retinal oedema - Fellow Eye | Eye disorders | KSI-301 (Arm A) | 19 | 230 | 19 |
| other | Diabetic retinal oedema - Fellow Eye | Eye disorders | Aflibercept (Arm B) | 21 | 230 | 22 |
| other | Conjunctival haemorrhage - Study Eye | Eye disorders | KSI-301 (Arm A) | 18 | 230 | 21 |
| other | Conjunctival haemorrhage - Study Eye | Eye disorders | Aflibercept (Arm B) | 15 | 230 | 21 |
| other | Cataract - Fellow Eye | Eye disorders | KSI-301 (Arm A) | 15 | 230 | 15 |
| other | Cataract - Fellow Eye | Eye disorders | Aflibercept (Arm B) | 12 | 230 | 12 |
| other | Dry eye - Study Eye | Eye disorders | KSI-301 (Arm A) | 13 | 230 | 15 |
| other | Dry eye - Study Eye | Eye disorders | Aflibercept (Arm B) | 10 | 230 | 11 |
1 to 10 of 270Source ClinicalTrials.gov
See all 270 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | KSI-301 (Arm A) | 5 | 230 |
| Total, all-cause mortality | Aflibercept (Arm B) | 5 | 230 |
| Total, other adverse events | KSI-301 (Arm A) | 126 | 230 |
| Total, other adverse events | Aflibercept (Arm B) | 121 | 230 |
| Total, serious adverse events | KSI-301 (Arm A) | 61 | 230 |
| Total, serious adverse events | Aflibercept (Arm B) | 51 | 230 |
Source ClinicalTrials.gov
Papers0
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 comparisons4
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| KSI-301 (Arm A) vs Aflibercept (Arm B): Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Studies KS301P104 and KS301P105 Combined | Trial comparisons |
| KSI-301 (Arm A) vs Aflibercept (Arm B): Percentage of Patients With a ≥ 2-step Worsening on the ETDRS DRSS in Study KS301P104 | Trial comparisons |
| KSI-301 (Arm A) vs Aflibercept (Arm B): deaths from any cause | Trial comparisons |
| KSI-301 (Arm A) vs Aflibercept (Arm B): serious adverse events | 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/NCT04611152
GET https://conductscience.org/api/trials/v1/NCT04611152/events?page=2