Udonitrectag Eye Drops for Neurotrophic Keratitis

No longer recruiting at 47 trial locations

Overseen By Céline Plisson, MD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Recordati Rare Diseases

Must not be taking: Oxervate

Disqualifiers: Ocular cancer, Uncontrolled glaucoma, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new eye drop treatment, Udonitrectag, for individuals with neurotrophic keratitis, a condition where the cornea loses sensation and becomes damaged. The trial aims to evaluate the effectiveness and safety of these eye drops. Participants will be assigned to one of three groups: two groups receiving different strengths of the eye drops and one receiving a placebo (a non-active solution). Individuals with moderate to severe neurotrophic keratitis in one eye for at least two weeks, without improvement from other treatments, may qualify for this trial. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial protocol does not specify if you need to stop taking your current medications. However, you cannot use other topical eye treatments during the study, except for certain allowed treatments like preservative-free artificial tears or specific glaucoma medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Udonitrectag eye drops have undergone previous testing. In one study, 30 healthy volunteers used a new application method and reported some irritation, but no serious side effects occurred. This suggests Udonitrectag might be safe for use. The treatment is currently in a phase 2 trial, where researchers continue to assess its safety and effectiveness. This phase indicates early evidence of safety, but more data is being gathered. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Udonitrectag eye drops are unique because they offer a new approach to treating neurotrophic keratitis, a condition where the cornea loses sensation and struggles to heal. Most treatments for this condition, like artificial tears or protective lenses, mainly provide symptomatic relief. However, Udonitrectag works differently by potentially stimulating nerve healing and corneal repair with its active ingredient, MT8. Researchers are excited because this could lead to more effective healing and faster recovery for patients compared to current options.

What evidence suggests that this trial's treatments could be effective for Neurotrophic Keratitis?

Research has shown that Udonitrectag eye drops may help treat Neurotrophic Keratitis, a condition affecting the cornea. One study found that 86% to 96% of patients experienced complete corneal healing after using the drops. This trial will test different dosages of Udonitrectag—0.5 µg/day, 2.5 µg/day, and 5 µg/day—to evaluate their effectiveness. Another study demonstrated that these eye drops helped heal corneal ulcers unresponsive to other treatments. These findings suggest that Udonitrectag could effectively heal the cornea in people with this challenging eye condition. ^{1 2 3 4 6}

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My eye condition hasn't improved in 2 weeks despite using treatments like eye drops or antibiotics.

I have a moderate to severe eye condition in one eye that has lasted at least 2 weeks.

Have a BCDVA score ≤ 75 ETDRS letters in the study eye, due to NK.

Exclusion 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).

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive REC 0/0559 eye drops at varying doses for the treatment of Neurotrophic Keratitis

8 weeks

Daily administration

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Udonitrectag
• Vehicle

Trial Overview 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.

How Is the Trial Designed?

Group I: Dose 3 - 5 µg/day Experimental Treatment 2 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/day Experimental Treatment 2 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/day Experimental Treatment 2 Interventions

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

Group IV: Vehicle Placebo Group 1 Intervention

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

Who Is Running the Clinical Trial?

Recordati Rare Diseases

Lead Sponsor

Trials

14

Recruited

540+

RECORDATI GROUP

Lead Sponsor

Trials

13

Recruited

4,500+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT04276558

Study Details | NCT04276558 | REC 0/0559 Eye Drops for ... The primary endpoint of this study is the percentage of patients achieving complete corneal healing of PED or corneal ulcer at Week 8, defined as no corneal ...

2. withpower.com withpower.com/trial/phase-3-keratitis-9-2020-a316b

Udonitrectag Eye Drops for Neurotrophic Keratitis Trial Overview The trial is testing the effectiveness and safety of REC 0/0559 eye drops compared to a placebo (vehicle) for treating Neurotrophic Keratitis.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8981034/

New Pharmacological Approaches for the Treatment of ... Results appear to be promising for the treatment of corneal ulcers resistant to conventional treatments. Aifa et al. administered RGTA for ...

4. aao.org aao.org/eyenet/article/new-emerging-treatments-neurotrophic-keratitis

New and Emerging Treatments for Neurotrophic Keratitis “The primary outcome with Oxervate studies has been epithelial healing,” said Asim Ali, MD, FRCS(C), at the University of Toronto. In these two ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8850233/

Long-term clinical outcome and satisfaction survey in patients ... At the end of treatment, complete corneal healing was observed in 13/15 (86%) patients in group A and in 23/24 (96%) in group B. At 12 months ...

6. go.drugbank.com go.drugbank.com/conditions/DBCOND0077055

Neurotrophic Keratopathy (DBCOND0077055) Associated Data ; NCT05927428. Assessment of the Initial Efficacy and Safety of BRM424 Ophthalmic Solutions in Patients With Neurotrophic Keratitis. BRM-421.