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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 belowSelect...
I have reduced feeling in my cornea due to an injury or ulcer.
Select...
I am 18 years old or older.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
My eye has a severe ulcer or a hole in the back part of the cornea.
Select...
I am currently pregnant, nursing, or planning to become pregnant.
Select...
I use contact lenses for vision correction or treatment in my affected eye(s).
Select...
I am willing to follow all study procedures and assessments.
Select...
I have been treated with Oxervate™ before.
Select...
My condition is Stage 2 or 3 NK or has perforation.
Select...
I do not have any active eye infections or inflammation unrelated to NK in my study eye.
Select...
I am not using strong birth control methods.
Select...
I have had eye cancer in the past.
Select...
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
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
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.
Specificity of a neuronotrophic factor from rabbit corneal epithelial cultures.
Find a Location
Who is running the clinical trial?
Recordati Rare DiseasesLead Sponsor
13 Previous Clinical Trials
431 Total Patients Enrolled
Syneos HealthOTHER
176 Previous Clinical Trials
68,453 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My eye has a severe ulcer or a hole in the back part of the cornea.I am currently pregnant, nursing, or planning to become pregnant.I use contact lenses for vision correction or treatment in my affected eye(s).You are allergic to any of the ingredients in the study drug or other medications used during the study.You have a history of heavy drinking or drug/solvent abuse.I had a corneal transplant in my study eye over 6 months ago for NK.I am willing to follow all study procedures and assessments.I am a male who can father children and agree to use condoms during and 4 weeks after the study.I had eye surgery less than 3 months ago, unless it caused my Stage 2 or 3 NK.I have a moderate to severe eye condition in one eye that has lasted at least 2 weeks.My eye condition hasn't improved in 2 weeks despite using treatments like eye drops or antibiotics.I have an eye condition treated with preservative-free drops, not affecting my study participation.My glaucoma is not controlled, or I use eye drops more than once a day.I don't have any eye or serious health issues that could affect the study.I have been treated with Oxervate™ before.I've had eye surgery for NK, but not AMT, and it's been weeks since.I use certain eye drops that are not part of the study's treatment.I have reduced feeling in my cornea due to an injury or ulcer.I may need or already have tear duct plugs during the study.I am 18 years old or older.My condition is Stage 2 or 3 NK or has perforation.I do not have any active eye infections or inflammation unrelated to NK in my study eye.I am not using strong birth control methods.I have had eye cancer in the past.You have severe vision loss in the eye being studied, and the doctor doesn't think the treatment will improve it.I have severe eyelid inflammation or severe gland issues in my eye.
Research Study Groups:
This trial has the following groups:- Group 1: Dose 3 - 5 µg/day
- Group 2: Dose 1 - 0.5 µg/day
- Group 3: Vehicle
- Group 4: Dose 2 - 2.5 µg/day
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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