Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
Public ClinicalTrials.gov record NCT04722991. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
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Official title
A Phase 2 Randomized, Placebo-controlled, Double-masked Proof-of-concept Study to Investigate the Efficacy and Safety of Runcaciguat (BAY 1101042) in Patients With Moderately Severe to Severe Non-proliferative Diabetic Retinopathy
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT04722991
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 109 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Mar 17, 2021 (Actual)
- Primary completion
- Mar 18, 2024 (Actual)
- Completion
- Apr 22, 2024 (Actual)
- Last update posted
- Apr 8, 2025
2021 – 2024
United States locations
- U.S. sites
- 11
- U.S. states
- 4
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Retinal Consultants Medical Group, Inc | Modesto | California | 95256 | — |
| Florida Retina Consultants | Lakeland | Florida | 33805 | — |
| Eye Associates of Pinellas | Pinellas Park | Florida | 33782 | — |
| Cumberland Valley Retina Consultants | Hagerstown, MD | Hagerstown | Maryland | 21740 | — |
| Mid Atlantic Retina Specialists - Hagerstown | Hagerstown | Maryland | 21740 | — |
| Austin Research Center for Retina | Austin | Texas | 78705-1023 | — |
| Austin Retina Associates - Central | Austin | Texas | 78705 | — |
| Retinal Consultants of Texas - Bellaire | Bellaire | Texas | 77401 | — |
| Gulf Coast Eye Institute / Valley Retina Institute | McAllen | Texas | 78503 | — |
| Retinal Consultants of Texas - San Antonio | San Antonio | Texas | 78240 | — |
| Retina Consultants of Texas - The Woodlands | The Woodlands | Texas | 77384 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 44 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT04722991, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Apr 8, 2025 · Synced Nov 5, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT04722991 live on ClinicalTrials.gov.