Udonitrectag Eye Drops for Neurotrophic Keratitis

Recruiting at43 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Recordati Rare Diseases

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Eligibility Criteria

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

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.

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).

Treatment Details

Interventions

• Udonitrectag (Unknown)
• Vehicle (Unknown)

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.

Participant Groups

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+

Syneos Health

Collaborator

Trials

181

Recruited

69,600+

Costa Panagos

Syneos Health

Chief Executive Officer

Bachelor's degree in a relevant field (specific details not available)

Suma Ramadas

Syneos Health

Chief Medical Officer since 2022

PhD in a relevant field (specific details not available)