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 bloodTherapeutic area: Diseases [C] - Eye Diseases [C11]
- Registration Number
- EUCTR2020-002333-15-IT
- Lead Sponsor
- BAYER AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 290
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 232
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 58
1. Presence or history of macular edema involving the center of the macula
2. Any kind of neovascular growth in the study eye, including anterior segment neovascularization
3. Arterial hypotension with systolic blood pressure < 100 or diastolic blood pressure < 60mmHg
4. Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 3 x Upper limit of normal (ULN) or bilirubin = 1.5 ULN at screening or Day 1, known ascites
5. Estimated glomerular filtration rate (eGFR CKD-EPI) below 45 ml/min/1.73 m^2 at screening
6. Any prior systemic anti-Vascular endothelial growth factor (VEGF) treatment or IVT anti-VEGF treatment in the study eye
7. Any prior intraocular steroid injection in the study eye
8. 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
9. 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: Part A: To establish the proof-of-concept for the efficacy of runcaciguat in the treatment of NPDR <br>Part B: To determine the dose level with best benefit-risk profile <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 24 Weeks of treatment<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, 72 and 96 weeks of treatment<br>DRSS improvement =2 steps at 48, 72 and 96 Weeks of treatment<br>Frequency of treatment emergent adverse events;Timepoint(s) of evaluation of this end point: at 48, 72 and 96 weeks of treatment<br>at 48, 72 and 96 weeks of treatment <br>from first administration till 28 days after the last dose of the treatment