A Phase 2 randomized, placebo-controlled, double-masked proof-of-concept study to investigate the efficacy and safety of runcaciguat (BAY 1101042) in patients with moderately severe to severe non-proliferative diabetic retinopathy.
- Conditions
- leakage of fluid and blood from blood vessels in the retinanon-proliferative diabetic retinopaty10047060
- Registration Number
- NL-OMON54177
- Lead Sponsor
- Bayer
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- Not specified
- Target Recruitment
- 9
- Moderately severe to severe NPDR in the study eye: DRSS levels 47 or 53
- Diabetes type 1 or 2
- BCVA ETDRS letter score in the study eye of >=69 letters (approximate Snellen
equivalent of 20/40 or better)
- Presence or history of macular edema involving the center of the macula
(defined as the area of the center subfield on OCT) in the study eye with
visual impairment or in need of treatment with anti-VEGF, immediately or
anticipated within the next 3 months, by judgement of the investigator or with
OCT central subfield thickness above gender specific thresholds, measured
including Bruch*s membrane, >=305 µm in women, >= 320 µm in men, as provided by
the central reading center
- 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-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 PRP in the study eye
- Use of nitrates or NO donors (such as amyl nitrate) in any form including
topical; PDE5 inhibitors, non-specific PDE inhibitors within 1 week before
first study drug administration
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Primary Outcome Measures:<br /><br>• DRSS improvement >=2 steps at 48 Weeks of treatment in the study eye<br /><br>DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.</p><br>
- Secondary Outcome Measures
Name Time Method <p>Secondary Outcome Measures:<br /><br>• Vision threatening complications at 48 weeks of treatment in the study eye<br /><br>• DRSS improvement >=2 steps at 24 Weeks of treatment in the study eye<br /><br>• Frequency of treatment emergent adverse events</p><br>