What side effects are associated with this type of intervention?

Common treatments for Neurotrophic Keratitis include topical antibiotics, autologous serum eye drops, and nerve growth factor (NGF) eye drops. Topical antibiotics can cause local irritation and allergic reactions. Autologous serum eye drops are generally well-tolerated but may cause mild discomfort or a transient burning sensation. NGF eye drops, such as cenegermin, can lead to eye pain, increased lacrimation, and conjunctival hyperemia. These treatments aim to promote corneal healing and nerve regeneration, similar to the goals of the REC 0/0559 trial.

What prior FDA approvals exist?

The FDA has approved several treatments for Neurotrophic Keratitis that focus on promoting corneal healing and nerve regeneration. One notable approval is cenegermin (Oxervate), a recombinant human nerve growth factor that helps in corneal healing by stimulating nerve growth. Another treatment is the use of autologous serum eye drops, which contain growth factors and vitamins that promote corneal repair. These treatments are designed to address the underlying nerve damage and support the regeneration and healing of the corneal tissue.

What other types of research exist?

Promising novel alternatives to REC 0/0559 for Neurotrophic Keratitis include Cenegermin (Oxervate), a recombinant human nerve growth factor that has been approved for NK treatment and has shown significant efficacy in promoting corneal healing. Additionally, emerging therapies such as thymosin beta 4 and various stem cell-based treatments are being investigated for their potential to enhance corneal nerve regeneration and repair.

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Udonitrectag Eye Drops for Neurotrophic Keratitis

Phase 2

Waitlist Available

Research Sponsored by Recordati Rare Diseases

Eligibility Criteria Checklist

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

Must have

Have decreased corneal sensitivity (≤ 4 cm using the Cochet-Bonnet aesthesiometer) within the area of the PED or corneal ulcer and outside of the area of the defect in at least one corneal quadrant.

Be a male or female aged ≥18 years at the time of ICF signature.

Must not have

Have evidence of corneal ulceration/melting involving the posterior third of the corneal stroma, or perforation in the study eye.

Be a woman who is pregnant, nursing or planning a pregnancy.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 8

Summary

This trial is testing a new treatment called REC 0/0559 for adults with an eye condition called Neurotrophic Keratitis. The study aims to see if this treatment can help improve eye health, ensure it is safe, and understand how it works in the body. The trial is being conducted in Europe and the United States.

Who is the study for?

Adults over 18 with moderate to severe Neurotrophic Keratitis (NK) in one eye, who haven't improved with standard treatments. They must have reduced corneal sensitivity and a specific level of vision impairment due to NK. Excluded are those allergic to study drugs, pregnant or nursing women, recent participants in other trials, unwilling to follow procedures, or with certain ocular conditions or surgeries.

What is being tested?

The trial is testing the effectiveness and safety of REC 0/0559 eye drops compared to a placebo (vehicle) for treating Neurotrophic Keratitis. It's a phase 2 study conducted across Europe and the USA that also looks at how the body processes the drug.

What are the potential side effects?

Potential side effects may include local eye irritation or discomfort, allergic reactions if sensitive to ingredients in REC 0/0559, and possibly systemic effects although these are not specified here.

Eligibility Criteria

Inclusion Criteria

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

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I have reduced feeling in my cornea due to an injury or ulcer.

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I am 18 years old or older.

Exclusion Criteria

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

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My eye has a severe ulcer or a hole in the back part of the cornea.

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I am currently pregnant, nursing, or planning to become pregnant.

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I use contact lenses for vision correction or treatment in my affected eye(s).

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I am willing to follow all study procedures and assessments.

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I have been treated with Oxervate™ before.

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My condition is Stage 2 or 3 NK or has perforation.

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

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I am not using strong birth control methods.

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I have had eye cancer in the past.

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I have severe eyelid inflammation or severe gland issues in my eye.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 8

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 8

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

Treatment Details

Study Objectives

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

Primary study objectives

Corneal healing

Secondary study objectives

Visual acuity

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: Dose 3 - 5 µg/dayExperimental Treatment2 Interventions

Dose of study drug per day: 5 µg/day Study drug concentration: 50 µg/mL MT8 given 1 drop QID

Group II: Dose 2 - 2.5 µg/dayExperimental Treatment2 Interventions

Dose of study drug per day: 2.5 µg/day Study drug concentration: 25 µg/mL MT8 given 1 drop QID

Group III: Dose 1 - 0.5 µg/dayExperimental Treatment2 Interventions

Dose of study drug per day: 0.5 µg/day Study drug concentration: 5 µg/mL MT8 given 1 drop QID

Group IV: VehiclePlacebo Group1 Intervention

Dose of study drug per day: 0 µg/day Study drug concentration: Vehicle given 1 drop QID

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Udonitrectag

2020

Completed Phase 2

~110

0 / 12Eligibility 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 focus on promoting corneal healing and nerve regeneration. These treatments often involve the use of growth factors and neurotrophic factors, such as nerve growth factor (NGF) and other biologics, which enhance the survival and function of corneal epithelial cells and support nerve regeneration. By stimulating cellular repair mechanisms and nerve regrowth, these treatments help restore corneal sensitivity and integrity, which is crucial for preventing further damage and improving vision in patients with Neurotrophic Keratitis.

Specificity of a neuronotrophic factor from rabbit corneal epithelial cultures.