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-LV
• Lead Sponsor: Bayer AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-06-14
• 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

- Uncontrolled diabetes mellitus as defined by HbA1c > 11.0% at screening
- Presence or history of macular edema involving the center of the macula
- Any kind of neovascular growth in the study eye, including anterior segment neovascularization
- Arterial hypotension with systolic blood pressure < 100 or diastolic blood pressure < 60mmHg
- ALT or AST above 3 x ULN or bilirubin = 1.5 ULN at screening, known ascites
- Estimated glomerular filtration rate (eGFR CKD-EPI) below 30 ml/min/1.73 m2 at screening
- Any prior systemic anti-Vascular endothelial growth factor (VEGF) treatment or IVT anti-VEGF treatment in the study eye
- Any prior intraocular steroid injection in the study eye
- 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
- 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

Primary Outcome Measures

Name	Time	Method
Main Objective: To establish the proof-of-concept for the efficacy of runcaciguat in the treatment of NPDR ;Secondary Objective: To investigate the safety and tolerability of runcaciguat in patients with NPDR ;Primary end point(s): Diabetic Retinopathy Severity Scale (DRSS) improvement =2 steps at 24 Weeks of treatment in the study eye<br>;Timepoint(s) of evaluation of this end point: 24 weeks after treatment

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Vision threatening complications at 48 week of treatment<br>DRSS improvement =2 steps at 48 week of treatment<br>Frequency of treatment emergent adverse events;Timepoint(s) of evaluation of this end point: at 48 week of treatment <br>from first administration till 28 days after the last dose of the treatment