What side effects are associated with this type of intervention?

Common treatments for Diabetic Retinopathy include GLP-1 receptor agonists and investigational drugs like Runcaciguat. GLP-1 receptor agonists have not shown a significant association with retinopathy but may cause gastrointestinal issues, such as nausea and vomiting. Runcaciguat, a soluble guanylate cyclase stimulator, is currently under investigation, and its side effects are not fully established. However, similar treatments may cause headaches, dizziness, and hypotension. Patients should discuss potential side effects with their healthcare provider to make an informed decision.

What prior FDA approvals exist?

The FDA has approved several treatments for diabetic retinopathy, primarily focusing on anti-VEGF (vascular endothelial growth factor) therapies. These include drugs like Aflibercept (Eylea), Ranibizumab (Lucentis), and Bevacizumab (Avastin), which work by inhibiting the growth of abnormal blood vessels in the retina. Additionally, corticosteroids such as Dexamethasone (Ozurdex) have been approved for reducing inflammation and edema associated with diabetic retinopathy. While Runcaciguat, a soluble guanylate cyclase stimulator, is being studied for its efficacy in treating diabetic retinopathy, it represents a novel approach compared to the existing FDA-approved therapies.

What other types of research exist?

Promising novel alternatives to Runcaciguat for diabetic retinopathy include vascular endothelial growth factor (VEGF) antagonists such as bispecific CrossMAb, which targets key angiogenic pathways, and other emerging VEGF inhibitors. Additionally, therapies targeting hypoxia-inducible factors (HIF) and other angiogenesis inhibitors are being explored for their potential efficacy in treating neovascular eye diseases.

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Soluble Guanylate Cyclase Stimulator

Runcaciguat for Diabetic Retinopathy (NEON-NPDR Trial)

Phase 2

Waitlist Available

Research Sponsored by Bayer

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderately severe to severe NPDR in the study eye: Diabetic Retinopathy Severity Scale (DRSS) levels 47 or 53

Diabetes type 1 or 2

Must not have

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

Alanine aminotransferase (ALT) or Aspartate aminotransferase (AST) above 3 x Upper limit of normal (ULN) or bilirubin ≥ 1.5 ULN at screening, known ascites

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at 48 weeks

Summary

This trial is testing runcaciguat, a medication for people with diabetic retinopathy. It aims to improve the health of the retina and reduce vision problems caused by diabetes. The study will measure changes in eye health over several months.

Who is the study for?

This trial is for adults with moderately severe to severe non-proliferative diabetic retinopathy (NPDR), having a specific severity level on the DRSS scale. Participants must have type 1 or type 2 diabetes and good visual acuity. Those who've had certain prior treatments, use nitrates or PDE5 inhibitors, have macular edema, neovascular growths, very low blood pressure, or significant liver/kidney dysfunction cannot join.

What is being tested?

The study tests Runcaciguat's safety and effectiveness against diabetic retinopathy compared to a placebo. The main goal is to see if there's an improvement in the retina after 24 weeks using color fundus photography. Vision-threatening complications are also monitored as a secondary measure of success over 48 weeks.

What are the potential side effects?

Specific side effects of Runcaciguat aren't detailed here but may include reactions similar to other drugs affecting blood vessels such as headaches, dizziness due to blood pressure changes, digestive issues or potential vision disturbances.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My eye condition due to diabetes is moderately severe to severe.

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I have diabetes.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I have had specific laser treatments near the center of my retina or all over my retina in the study eye.

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My liver tests are high or I have fluid in my abdomen.

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My kidney function is significantly reduced.

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I have had a steroid injection in my eye.

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I have received treatments targeting blood vessel growth in my eye.

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I have or had swelling in the central part of my retina.

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I haven't used nitrates, NO donors, or PDE5 inhibitors recently.

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I have abnormal blood vessel growth in my eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at 48 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at 48 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and at 48 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

DRSS improvement ≥2 steps at 48 weeks of treatment in the study eye

Secondary study objectives

DRSS improvement ≥ 3 steps at 48 weeks of treatment on the scale for persons

DRSS improvement ≥2 steps at 24 weeks of treatment in the study eye

Frequency of treatment emergent adverse events

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Runcaciguat (BAY1101042)Experimental Treatment1 Intervention

Group II: PlaceboPlacebo Group1 Intervention

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Runcaciguat (BAY1101042)

2021

Completed Phase 2

~110

0 / 10Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Diabetic Retinopathy include anti-VEGF (vascular endothelial growth factor) injections, corticosteroids, laser therapy, and soluble guanylate cyclase (sGC) stimulators like Runcaciguat. Anti-VEGF injections work by inhibiting the growth of abnormal blood vessels in the retina, reducing leakage and swelling. Corticosteroids reduce inflammation and edema. Laser therapy seals leaking blood vessels and prevents the growth of new ones. sGC stimulators, such as Runcaciguat, enhance the nitric oxide signaling pathway, improving blood flow and reducing retinal damage. These treatments are crucial as they target the underlying pathophysiological processes of Diabetic Retinopathy, helping to preserve vision and prevent complications.