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NCT04722991 · ClinicalTrials.gov registry record · Phase 2
Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
A Phase 2 study, sponsored by Bayer.
- Completed
- Registry status
- Phase 2
- Development phase
- 109
- Enrollment target
NCT04722991: Completed Phase 2 study, sponsored by Bayer.
NCT04722991 is a Phase 2 study that has completed, run by Bayer. The registered enrollment target is 109 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04722991, a Phase 2 study, has completed, sponsored by Bayer.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 109 participants
- Enrollment target
Study Summary
This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography for central assessment of the diabetic retinopathy severity score, or DRSS. Two-step DRSS improvement at 24 weeks of treatment will be the primary efficacy endpoint. DRSS assessments are repeated after completion of 48 weeks of treatment. In addition, vision threatening complications will be recorded throughout the study and assessed as secondary efficacy endpoint.
Primary Outcome
DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.
Interventions
- OTHER Placebo
- DRUG Runcaciguat (BAY1101042)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 109 participants |
| Start Date | 2021-03-17 |
| Est. Completion | 2024-04-22 |
| Phase | Phase 2 |
What the finished NCT04722991 record still lists
NCT04722991 is an interventional study that assigns participants to a tested intervention. The registered 109 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (18% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04722991 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04722991 about?
NCT04722991 is a clinical study titled "Non-proliferative Diabetic Retinopathy Treated With Runcaciguat". This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography for central assessment of the diabetic retinopathy severity score, or DR...
What is the current status of trial NCT04722991?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 109 participants. The study started on 2021-03-17. Estimated completion is 2024-04-22.
What interventions are being tested in trial NCT04722991?
The interventions under investigation include: Placebo (OTHER), Runcaciguat (BAY1101042) (DRUG).
Who is sponsoring clinical trial NCT04722991?
This trial is sponsored by Bayer, which has 591 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04722991's enrollment target sits among peer trials
109 640th of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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