What side effects are associated with this type of intervention?

Treatments for Neurotrophic Keratitis that promote corneal healing through neurotrophic or regenerative pathways, such as CSB-001, can cause side effects including ocular discomfort, conjunctival hyperemia, and increased intraocular pressure. Prolonged use may also lead to cataract formation or worsening of existing cataracts. Close monitoring and adjustment of treatment are essential to manage these potential side effects.

What prior FDA approvals exist?

The FDA has approved several treatments for neurotrophic keratitis that promote corneal healing through neurotrophic or regenerative pathways. One notable example is cenegermin (Oxervate), a recombinant human nerve growth factor, which is specifically designed to treat neurotrophic keratitis by stimulating corneal healing and nerve regeneration. Another treatment is the use of autologous serum eye drops, which contain growth factors and vitamins that aid in corneal repair. These treatments align with the mechanisms being studied in the CSB-001 trial, which also aims to promote corneal healing through similar pathways.

What other types of research exist?

Promising alternatives to CSB-001 for Neurotrophic Keratitis include: 1) Neprilysin inhibitors like thiorphan, which have shown to accelerate corneal wound healing. 2) RGTA (ReGeneraTing Agent) therapy, which has demonstrated efficacy in restoring stromal microarchitecture and reducing haze in corneal wounds. 3) Stem cell therapies, particularly those using peripheral blood mononuclear cells (PBMNCs) differentiated into corneal epithelial cells, which have shown potential in corneal epithelial regeneration.

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Ophthalmic Solution

CSB-001 Eye Drops for Neurotrophic Keratitis

Phase 1 & 2

Waitlist Available

Research Sponsored by Claris Biotherapeutics, Inc.

Eligibility Criteria Checklist

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

Must have

Subjects with stage 2 (PED) or stage 3 (corneal ulcer) neurotrophic keratitis (NK)

Subjects with clinical evidence of decreased corneal sensitivity within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant in the study eye

Must not have

Any other ocular disease, except glaucoma, that will require topical ocular treatment in the study eye over the course of the study

Previous use of Oxervate in the study eye with last administration within the past 2 months

Timeline

Screening 3 weeks

Treatment Varies

Follow Up weeks 4 and 8 through week 10

Summary

This trial tests CSB-001, a new treatment for people with moderate to severe neurotrophic keratitis. The treatment aims to help heal the damaged surface of their eyes. Cenegermin, a nerve growth factor eye drop, has shown promise in improving corneal sensitivity and healing in neurotrophic keratitis.

Who is the study for?

This trial is for people with moderate to severe neurotrophic keratitis, which affects the cornea of the eye. Participants must have shown no improvement despite standard treatments and be willing to follow study procedures. They can't join if they've used Oxervate recently, have other eye diseases needing treatment during the study (except controlled glaucoma), or any active infections in their eyes.

What is being tested?

The trial tests CSB-001 Ophthalmic Solution against a placebo control. Participants are randomly chosen to receive either the test medication or placebo, applying it four times daily for 8 weeks with weekly clinic visits. Those on placebo without healing may later try the actual drug in an open-label phase.

What are the potential side effects?

While specific side effects aren't listed here, ophthalmic solutions like CSB-001 can typically cause eye irritation, redness, discomfort or blurred vision temporarily after application.

Eligibility Criteria

Inclusion Criteria

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

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I have stage 2 or 3 neurotrophic keratitis.

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I have reduced feeling in my eye's cornea, both where there is damage and in other parts.

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My eye condition hasn't improved in 2 weeks despite treatment.

Exclusion Criteria

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

Select...

I have an eye condition other than glaucoma that needs treatment.

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I used Oxervate for my eye condition within the last 2 months.

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I do not have any active eye infections or inflammation unrelated to NK.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ weeks 4 and 8 through week 10

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~weeks 4 and 8 through week 10

This trial's timeline: 3 weeks for screening, Varies for treatment, and weeks 4 and 8 through week 10 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Efficacy as Assessed by Complete Corneal Healing

Safety as Assessed by Adverse Event Reporting

Safety as Assessed by Best-Corrected Distance Visual Acuity

+3 more

Secondary study objectives

Efficacy as Assessed by Best Corrected Distance Visual Acuity

Efficacy as Assessed by Corneal Healing

Efficacy as Assessed by Corneal Healing at Week 4

+3 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: CSB-001 Investigational Treatment ArmExperimental Treatment1 Intervention

One drop CSB-001 four times daily for 8 weeks in the study eye

Group II: Vehicle Control ArmPlacebo Group1 Intervention

One drop matching vehicle four times daily for 8 weeks in the study eye

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

CSB-001 Ophthalmic Solution 0.1%

2021

Completed Phase 2

~140

0 / 6Eligibility 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

The most common treatments for Neurotrophic Keratitis include agents that promote corneal healing through neurotrophic or regenerative pathways. These treatments often involve the use of growth factors, such as nerve growth factor (NGF), which support nerve regeneration and enhance corneal epithelial healing. Additionally, regenerative therapies like mesenchymal stem cells (MSCs) can secrete neurotrophic factors that aid in tissue repair and reduce inflammation. These mechanisms are crucial for Neurotrophic Keratitis patients as they address the underlying nerve damage and impaired healing capacity, thereby improving corneal health and preventing further complications.

Local overexpression of nerve growth factor in rat corneal transplants improves allograft survival.