MR-146 in Neurotrophic Keratopathy: a first-in-human dose escalation and blinded comparison

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a two-part, multicenter trial of MR-146 in adults with neurotrophic keratopathy. Part 1 is open-label and dose-escalation to evaluate safety, tolerability, and biologically active dose. Part 2 is a double-masked comparison in stage 2 NK to further assess efficacy and safety. The study follows participants for about 12–14 months with regular visits to monitor ocular health and treatment effects.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Be ≥18 years or greater of age at Visit 1.
2. Have a diagnosis of Stage 1 or Stage 2 in the study eye for Part 1 or Stage 2 NK in the study eye for Part 2.
3. Willing and able to participate in and attend to all study visits over the course of 12-14 months

Exclusion Criteria:

1. Have Stage 2 NK affecting both eyes, or Stage 3 NK in either eye.
2. Any active ocular infections or active ocular inflammation not related to NK in the affected eye.
3. Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study
4. Have monocular vision in the study eye or have BSCVA less than 20/100 in the fellow eye.
5. Any neurodegenerative disease (example: Parkinson's, Alzheimer's, Multiple Sclerosis, etc)
6. Uncontrolled glaucoma in either eye.
7. Any plan to use therapeutic contact lenses.
8. Anyone pregnant, nursing, or planning to become pregnant within 3 months of participating in the study.
9. History of incisional conjunctival surgery in the study eye.
10. History of any ocular surgery in the affected eye within the last 3 months
11. Botox use in the face or orbital area and/or lacrimal gland within the last 6 months.

Where it's running

• Horizon Eye/DocTrials
  Sun City, Arizona, United States Recruiting
• Nvision
  Tucson, Arizona, United States Recruiting
• Loma Linda University Eye Institute
  Loma Linda, California, United States Recruiting
• NVision
  San Diego, California, United States Recruiting
• Vision Institute
  Colorado Springs, Colorado, United States Recruiting
• Butchertown Clinical Trials
  Louisville, Kentucky, United States Recruiting

Study contacts

• Study coordinator: Jason Dierkhising
• Email: patientrecruitment@oraclinical.com
• Phone: 1707-484-1365

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using platelet-rich plasma to treat neurotrophic keratopathy

  This study is testing whether using a special treatment made from your own blood can help people with neurotrophic keratopathy heal their corneas better than just using artificial tears alone.

  Recruiting Universidad Autonoma de Nuevo Leon · Monterrey, Nuevo León · NCT04604834

• Acoltremon 0.003% eye drops to improve tears and corneal health in Stage 1 neurotrophic keratopathy

  This study will test whether Acoltremon 0.003% eye drops, used twice daily, can increase tear production and improve corneal signs in people with Stage 1 neurotrophic keratopathy who have low tear production.

  Recruiting Phase 4 University of South Florida · Tampa, Florida · NCT07502378

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.