Non-proliferative Diabetic Retinopathy Treated With Runcaciguat
Completed · Phase 2 · Has a placebo group
Conditions studied: Diabetic Retinopathy
In brief
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.
Key facts
- Study ID
- NCT04722991
- Run by
- Bayer
- People needed
- 109
- Starts
- 2021-03-17
- Expected to finish
- 2024-04-22
- Last updated by the study team
- 2025-04-08
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Florida Retina Consultants — Lakeland, Florida, United States
- Eye Associates of Pinellas — Pinellas Park, Florida, United States
- Cumberland Valley Retina Consultants | Hagerstown, MD — Hagerstown, Maryland, United States
- Mid Atlantic Retina Specialists - Hagerstown — Hagerstown, Maryland, United States
- Austin Research Center for Retina — Austin, Texas, United States
- Austin Retina Associates - Central — Austin, Texas, United States
- Retinal Consultants of Texas - Bellaire — Bellaire, Texas, United States
- Gulf Coast Eye Institute / Valley Retina Institute — McAllen, Texas, United States
- Retinal Consultants of Texas - San Antonio — San Antonio, Texas, United States
- Retina Consultants of Texas - The Woodlands — The Woodlands, Texas, United States
- Eye center Sveti Luka — Plovdiv, Bulgaria
- UMHAT Sveti Georgi — Plovdiv, Bulgaria
- SEHAT Pentagram — Sofia, Bulgaria
- Diagnostic-Consultative Center Alexandrovska | Sofia, Bulgaria — Sofia, Bulgaria
- Sveta Petka Eye Hospital — Varna, Bulgaria
- Ocni klinika Oftex — Pardubice, Czechia
- Fakultni nemocnice Kralovske Vinohrady — Prague, Czechia
- Všeobecná fakultní nemocnice v Praze — Prague, Czechia
- Axon Clinical, s.r.o. — Prague, Czechia
- Aalborg Universitetshospital - Øjenafdelingen — Aalborg, Denmark
- Aarhus Universitetshospital — Aarhus N, Denmark
- Rigshospitalet Glostrup - Øjensygdomme — Glostrup Municipality, Denmark
- Odense Universitetshospital, Dept of Ophtalmology — Odense C, Denmark
- Sjællands Universitetshospital Roskilde - Hormon og stofskiftesygdomme — Roskilde, Denmark
- Retinal Consultants Medical Group, Inc — Modesto, California, United States
Full record on ClinicalTrials.gov
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