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Trial record 3 of 4 for:    BAY1101042
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Non-proliferative Diabetic Retinopathy Treated With Runcaciguat (NEON-NPDR)

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ClinicalTrials.gov Identifier: NCT04722991
Recruitment Status : Active, not recruiting
First Posted : January 25, 2021
Last Update Posted : April 4, 2024
Sponsor:
Information provided by (Responsible Party):
Bayer

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Diabetic Retinopathy Drug: Runcaciguat (BAY1101042) Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 104 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description: double-masked study
Primary Purpose: Treatment
Official 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
Actual Study Start Date : March 17, 2021
Estimated Primary Completion Date : April 25, 2024
Estimated Study Completion Date : April 25, 2024

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Arms and Interventions
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Arm Intervention/treatment
Experimental: Runcaciguat (BAY1101042) Drug: Runcaciguat (BAY1101042)
Oral dose of runcaciguat
Placebo Comparator: Placebo Other: Placebo
Oral dose of matching placebo


Outcome Measures
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Primary Outcome Measures :
  1. DRSS improvement ≥2 steps at 48 weeks of treatment in the study eye [ Time Frame: At 48 weeks of treatment ]
    DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.


Secondary Outcome Measures :
  1. Vision threatening complications at 48 weeks of treatment in the study eye [ Time Frame: At 48 weeks ]
  2. DRSS improvement ≥2 steps at 24 weeks of treatment in the study eye [ Time Frame: At 24 weeks ]
    DRSS (Diabetic Retinopathy Severity Scale) will be graded centrally.

  3. Frequency of treatment emergent adverse events [ Time Frame: From first dosing up to 28 days after last dose of study intervention. ]
    As reported by Investigators


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04722991


Locations
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Sponsors and Collaborators
Bayer
More Information
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Additional Information:

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Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT04722991    
Other Study ID Numbers: 20739
2020-002333-15 ( EudraCT Number )
First Posted: January 25, 2021    Key Record Dates
Last Update Posted: April 4, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description:

Availability of this study's data will later be determined according to Bayer's commitment to the EFPIA/PhRMA "Principles for responsible clinical trial data sharing". This pertains to scope, timepoint and process of data access.

As such, Bayer commits to sharing upon request from qualified researchers patient-level clinical trial data, study-level clinical trial data, and protocols from clinical trials in patients for medicines and indications approved in the US and EU as necessary for conducting legitimate research. This applies to data on new medicines and indications that have been approved by the EU and US regulatory agencies on or after January 01, 2014.

Interested researchers can use www.vivli.org to request access to anonymized patient-level data and supporting documents from clinical studies to conduct research. Information on the Bayer criteria for listing studies and other relevant information is provided in the member section of the portal.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Bayer:
Non-proliferative Diabetic Retinopathy
Additional relevant MeSH terms:
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Retinal Diseases
Diabetic Retinopathy
Eye Diseases
Diabetic Angiopathies
Vascular Diseases
 Cardiovascular Diseases
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases