on-proliferative diabetic retinopathy treated with runcaciguat
- 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 bloodMedDRA version: 20.1Level: LLTClassification code 10054109Term: Non-proliferative diabetic retinopathySystem Organ Class: 100000004853Therapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2020-002333-15-NL
- Lead Sponsor
- Bayer AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 196
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 78
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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 or diastolic blood pressure < 60mmHg
5. ALT or Aspartate aminotransferase (AST) above 3 x Upper limit of normal (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 NO donors (such as amyl nitrate) in any form including topical; PDE5 inhibitors, non-specific PDE inhibitors within 1 week or less than 5 half-lives (whichever is longer) 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<br>treatment of NPDR<br>;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 48 Weeks of treatment in the study eye<br>;Timepoint(s) of evaluation of this end point: 48 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 24 week of treatment in the study eye<br>Frequency of treatment emergent adverse events;Timepoint(s) of evaluation of this end point: at 48 weeks of treatment <br>from first administration till 28 days after the last dose of the treatment