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Completed

NCT Number: NCT04722991

Non-proliferative Diabetic Retinopathy Treated With Runcaciguat

This Phase 2 study is conducted to investigate the safety and efficacy of runcaciguat in the treatment of diabetic retinopathy. To assess efficacy, the retinal morphology will be investigated by 7-field color fundus photography for central assessment of the diabetic retinopathy severity score, or DRSS. Two-step DRSS improvement at 24 weeks of treatment will be the primary efficacy endpoint. DRSS assessments are repeated after completion of 48 weeks of treatment. In addition, vision threatening complications will be recorded throughout the study and assessed as secondary efficacy endpoint.

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Key information

Conditions

Diabetic Retinopathy Cardiovascular Diseases Diabetes Complications Diabetes Mellitus Diabetic Angiopathies Endocrine System Diseases Eye Diseases Retinal Diseases Vascular Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Eye center Sveti Luka, Plovdiv, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Main Inclusion Criteria:

  • Moderately severe to severe NPDR in the study eye: Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53
  • Diabetes type 1 or 2
  • Best corrected visual acuity (BCVA) Early Treatment Diabetic Retinopathy Study (ETDRS) letter score in the study eye of ≥69 letters (approximate Snellen equivalent of 20/40 or better)

Main Exclusion Criteria:

  • 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
  • Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 3 x Upper limit of normal (ULN) or bilirubin ≥ 1.5 ULN at screening, known ascites
  • Estimated glomerular filtration rate (eGFR CKD-EPI) below 30 ml/min/1.73 m^2 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, nonspecific PDE inhibitors within 1 week or less than 5 half-lives (whichever is longer) before first study drug administration

Treatment and study plan

Runcaciguat (BAY1101042)

Drug

Oral dose of runcaciguat

Placebo

Other

Oral dose of matching placebo

Primary outcomes

  1. Percentage of Participants With Improvement in DRSS by ≥ 2 Steps at 48 Weeks of Treatment in the Study Eye

    Time frame: At 48 weeks of treatment

    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.

Secondary outcomes

  1. Percentage Participants With Vision Threatening Complications (VTC) at 48 Weeks of Treatment in the Study Eye

    Time frame: At 48 weeks

    VTC are defined as occurrence of any of the following AEs:

    • Proliferative diabetic retinopathy (PDR) (DRSS ≥61)
    • Any ocular neo-vascularization (retinal or anterior-segment neovascularization)
    • Center-involved (central Early Treatment Diabetic Retinopathy Study [ETDRS] subfield) DME
    • Drop of Best corrected visual acuity (BCVA) of 10 letters or more from baseline

  2. Percentage of Participants With ≥ 2 Steps Improvement in DRSS at 24 Weeks of Treatment in the Study Eye

    Time frame: At 24 weeks of treatment

    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.

  3. Percentage of Participants With ≥ 3 Steps Improvement in DRSS at 48 Weeks of Treatment on the for Persons Scale

    Time frame: At 48 weeks of treatment

    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.

  4. Number of Participants With Treatment Emergent Adverse Event (TEAE)

    Time frame: From first dosing up to 28 days after last dose of study intervention

Other outcomes

  1. Percentage of Participants With < 3 Steps Deterioration in DRSS at 48 Weeks of Treatment on the for Persons Scale

    Time frame: At 48 weeks of treatment

    DRSS (Diabetic Retinopathy Severity Scale) is measured on a 13-point scale and was graded centrally for the study.

Sponsors and collaborators

Lead sponsor

Bayer

Industry

Registry information

Official study title

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

Acronym: NEON-NPDR

Important dates

Study start
2021
Primary completion
2024
Study completion
2024
First posted
Jan 25, 2021
Registry last updated
Apr 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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