on-proliferative diabetic retinopathy treated with runcaciguat

Phase 1

• Conditions: - Non-proliferative diabetic retinopathy: early stage of a medical condition in which damage occurs to the retina due to diabetes mellitus (DM)- DM is characterized by too much sugar in the blood; MedDRA version: 20.1Level: LLTClassification code 10054109Term: Non-proliferative diabetic retinopathySystem Organ Class: 100000004853; Therapeutic area: Diseases [C] - Eye Diseases [C11]

• Registration Number: EUCTR2020-002333-15-CZ
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2020-12-08
• Last Update Posted: 3 June 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 196

Inclusion Criteria

1. Moderately severe to severe NPDR in the study eye: Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53
2. Diabetes type 1 or 2
3. Best corrected visual aquity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of =69 letters (approximate Snellen equivalent of 20/40 or better)

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 157
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 39

Exclusion Criteria

1. Uncontrolled diabetes mellitus as defined by HbA1c > 11.0% at
screening
2. Presence or history of macular edema involving the center of the macula
3. Any kind of neovascular growth in the study eye, including anterior segment neovascularization
4. Arterial hypotension with systolic blood pressure < 100 (ALT) or diastolic blood pressure < 60mmHg
5. ALT or AST above 3 x ULN or bilirubin = 1.5 ULN at screening, known ascites
6. Estimated glomerular filtration rate (eGFR CKD-EPI) below 30 ml/min/1.73 m^2 at screening
7. Any prior systemic anti-Vascular endothelial growth factor (VEGF) treatment or IVT anti-VEGF treatment in the study eye
8. Any prior intraocular steroid injection in the study eye
9. Any prior grid or focal laser photocoagulation within 500 microns of the foveal center or any prior Pan-retinal photocoagulation (PRP) in the study eye
10. Use of nitrates or Nitric oxide (NO) donors (such as amyl nitrate) in any form including topical; Phosphodiesterase 5 (PDE5) inhibitors, non-specific PDE inhibitors within 1 week before first study drug administration

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified