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.

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. - NEON-NPDR

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

NL-OMON

Registry ID

NL-OMON54177

Enrollment

Registered

2021-02-05

Start date

2022-06-15

Completion date

Unknown

Last updated

2024-04-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

leakage of fluid and blood from blood vessels in the retina non-proliferative diabetic retinopaty

Interventions

Runcaciguat is being compared to placebo.

Eligibility

Age

18 Years to 99 Years

Inclusion criteria

Inclusion criteria: - 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)

Exclusion criteria

Exclusion criteria: - 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 = 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

Design outcomes

Primary

Measure	Time frame
Primary Outcome Measures: • DRSS improvement >=2 steps at 48 Weeks of treatment in the study eye DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.	—

Secondary

Measure	Time frame
Secondary Outcome Measures: • Vision threatening complications at 48 weeks of treatment in the study eye • DRSS improvement >=2 steps at 24 Weeks of treatment in the study eye • Frequency of treatment emergent adverse events	—

Countries

Netherlands

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)