Trial · NCT04722991
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
NCT04722991, Phase 2, Completed, Bayer; results first posted 2025-04-08
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Non-proliferative Diabetic Retinopathy Treated With Runcaciguat. Trials, record NCT04722991. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04722991
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
- NCT number
- NCT04722991
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 109 participants, actual
- Lead sponsor
- Bayer
- Conditions
- Diabetic Retinopathy
- Interventions
- Runcaciguat (BAY1101042), Placebo
- First posted
- 2021-01-25
- Last updated
- 2025-04-08
- Other registries' IDs
- eudract:2020-002333-15
- Results first posted
- 2025-04-08
Source ClinicalTrials.gov
Registered outcomes6
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye | At 48 weeks of treatment | DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study. |
| Secondary | Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye | At 48 weeks | VTC are defined as occurrence of any of the following AEs: * Proliferative diabetic retinopathy (PDR) (DRSS ≥61) * Any ocular neo-vascularization (retinal or anterior-segment neovascularization) * Center-involved (central Early Treatment Diabetic Retinopathy Study \[ETDRS\] subfield) DME * Drop of Best corrected visual acuity (BCVA) of 10 letters or more from baseline |
| Secondary | Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye | At 24 weeks of treatment | DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study. |
| Secondary | Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale | At 48 weeks of treatment | DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study. |
| Secondary | Number of Participants With Treatment Emergent Adverse Event (TEAE) | From first dosing up to 28 days after last dose of study intervention | |
| Other | Percentage of Participants With < 3 Steps Deterioration in DRSS at 48 Weeks of Treatment on the for Persons Scale | At 48 weeks of treatment | DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study. |
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 | Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye | At 48 weeks of treatment | per protocol set: all full analysis set (FAS) participants of the respective study part without validity findings. | percentage of participants | NUMBER |
| SECONDARY | Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye | At 48 weeks | per protocol set: all full analysis set (FAS) participants of the respective study part without validity findings. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye | At 24 weeks of treatment | per protocol set: all full analysis set (FAS) participants of the respective study part without validity findings. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale | At 48 weeks of treatment | per protocol set: all full analysis set (FAS) participants of the respective study part without validity findings. | percentage of participants | NUMBER |
| SECONDARY | Number of Participants With Treatment Emergent Adverse Event (TEAE) | From first dosing up to 28 days after last dose of study intervention | Safety analysis set (SAF): All participants of the respective study part who took at least one dose of study intervention. | Participants | COUNT_OF_PARTICIPANTS |
| OTHER_PRE_SPECIFIED | Percentage of Participants With < 3 Steps Deterioration in DRSS at 48 Weeks of Treatment on the for Persons Scale | At 48 weeks of treatment | per protocol set: all full analysis set (FAS) participants of the respective study part without validity findings. | percentage of participants | NUMBER |
Source ClinicalTrials.gov
Results by group12
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye | Runcacigat (BAY1101042) | 0.0 | 95% Confidence Interval 0.0 to 4.7 | percentage of participants | |
| Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye | Placebo | 1.9 | 95% Confidence Interval 0.2 to 8.7 | percentage of participants | |
| Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye | Runcacigat (BAY1101042) | 17.6 | percentage of participants | ||
| Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye | Placebo | 11.5 | percentage of participants | ||
| Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye | Runcacigat (BAY1101042) | 0.0 | 95% Confidence Interval 0.0 to 4.8 | percentage of participants | |
| Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye | Placebo | 0.0 | 95% Confidence Interval 0.0 to 4.7 | percentage of participants | |
| Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale | Runcacigat (BAY1101042) | 0.0 | 95% Confidence Interval 0.0 to 4.7 | percentage of participants | |
| Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale | Placebo | 1.9 | 95% Confidence Interval 0.2 to 8.7 | percentage of participants | |
| Number of Participants With Treatment Emergent Adverse Event (TEAE) | Runcacigat (BAY1101042) | 53 | Participants | ||
| Number of Participants With Treatment Emergent Adverse Event (TEAE) | Placebo | 44 | Participants |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 results by groupParticipant flow6
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Runcacigat (BAY1101042) | 56 | |
| Overall Study | STARTED | Placebo | 53 | |
| Overall Study | COMPLETED | Runcacigat (BAY1101042) | 38 | |
| Overall Study | COMPLETED | Placebo | 44 | |
| Overall Study | NOT COMPLETED | Runcacigat (BAY1101042) | 18 | |
| Overall Study | NOT COMPLETED | Placebo | 9 |
Source ClinicalTrials.gov
Adverse events118
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 | Anaemia | Blood and lymphatic system disorders | Runcaciguat (BAY1101042) | 3 | 56 | 3 |
| other | Anaemia | Blood and lymphatic system disorders | Placebo | 2 | 53 | 2 |
| other | Erythropenia | Blood and lymphatic system disorders | Runcaciguat (BAY1101042) | 3 | 56 | 3 |
| other | Erythropenia | Blood and lymphatic system disorders | Placebo | 0 | 53 | 0 |
| other | Diabetic retinal oedema | Eye disorders | Runcaciguat (BAY1101042) | 2 | 56 | 2 |
| other | Diabetic retinal oedema | Eye disorders | Placebo | 3 | 53 | 4 |
| other | Diabetic retinopathy | Eye disorders | Runcaciguat (BAY1101042) | 3 | 56 | 3 |
| other | Diabetic retinopathy | Eye disorders | Placebo | 2 | 53 | 2 |
| other | Dry eye | Eye disorders | Runcaciguat (BAY1101042) | 1 | 56 | 1 |
| other | Dry eye | Eye disorders | Placebo | 3 | 53 | 3 |
1 to 10 of 118Source ClinicalTrials.gov
See all 118 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Runcaciguat (BAY1101042) | 2 | 56 |
| Total, all-cause mortality | Placebo | 0 | 53 |
| Total, other adverse events | Runcaciguat (BAY1101042) | 50 | 56 |
| Total, other adverse events | Placebo | 32 | 53 |
| Total, serious adverse events | Runcaciguat (BAY1101042) | 9 | 56 |
| Total, serious adverse events | Placebo | 3 | 53 |
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 comparisons3
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Runcacigat (BAY1101042) vs Placebo: Number of Participants With Treatment Emergent Adverse Event (TEAE) | Trial comparisons |
| Runcaciguat (BAY1101042) vs Placebo: deaths from any cause | Trial comparisons |
| Runcaciguat (BAY1101042) vs Placebo: 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/NCT04722991
GET https://conductscience.org/api/trials/v1/NCT04722991/events?page=2