What this study is
Simplified from ClinicalTrials.govTesting a single-dose treatment (MR-146) to learn about its safety and the best dose for neurotrophic keratopathy, a disease of the cornea (the clear front of the eye), in adults 18 or older with stage 1 or 2 of it. Only people with stage 2 can join the study's second part.
Read the original summary from ClinicalTrials.gov
The objective of this study is to evaluate the safety, tolerability, and biologically effective dose (BED) of MR-146 for the treatment of Stage 1 and Stage 2 Neurotrophic Keratopathy (NK)
What's being tested
- MR-146
Intervention · GENETIC
gene therapy product for the treatment of stage I/II NK.
Study details
- Sponsor
- Viatris Inc.
- Conditions
- Neurotrophic Keratopathy
- Enrolling
- 18 people
- Starts
- 2026-11
- Est. completion
- 2028-11
- Design
- Open-label, non-randomized, single group, Phase 1, Phase 2
- Record
- View on ClinicalTrials.gov ↗
Who can join
Age 18 Years and overSex ALLHealthy volunteers Not acceptedYou may qualify if
- Be ≥18 years or greater of age at Visit 1.
- 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.
- Willing and able to participate in and attend to all study visits over the course of 12-14 months
You can't join if
- Have Stage 2 NK affecting both eyes, or Stage 3 NK in either eye.
- Any active ocular infections or active ocular inflammation not related to NK in the affected eye.
- Have a systemic condition or disease not stabilized or judged by the Investigator to be incompatible with participation in the study
- Have monocular vision in the study eye or have BSCVA less than 20/100 in the fellow eye.
- Any neurodegenerative disease (example: Parkinson's, Alzheimer's, Multiple Sclerosis, etc)
- Uncontrolled glaucoma in either eye.
- Any plan to use therapeutic contact lenses.
- Anyone pregnant, nursing, or planning to become pregnant within 3 months of participating in the study.
- History of incisional conjunctival surgery in the study eye.
- History of any ocular surgery in the affected eye within the last 3 months
- Botox use in the face or orbital area and/or lacrimal gland within the last 6 months.
Sign in and we'll check these against your records.Full criteria on ClinicalTrials.gov ↗
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Study locations (11)
11 openHorizon Eye/DocTrials
Sun City, Arizona, United States
- Cason · Contact
RecruitingNvision
Tucson, Arizona, United States
- Villavicencio · Contact
RecruitingGlobal Research Management
Glendale, California, United States
- El-Harazi · Contact
Not yet recruitingLoma Linda University Eye Institute
Loma Linda, California, United States
- Affeldt · Contact
RecruitingNVision
San Diego, California, United States
- Pillar · Contact
RecruitingVision Institute
Colorado Springs, Colorado, United States
- Simmons · Contact
RecruitingButchertown Clinical Trials
Louisville, Kentucky, United States
- Pattar · Contact
Recruiting3RP (Red River Research Partners)
Fargo, North Dakota, United States
- Keating · Contact
RecruitingEyeHealth Northwest
Portland, Oregon, United States
- Holland · Contact
RecruitingStuart A. Terry Eye Associates
San Antonio, Texas, United States
- Alsheikh · Contact
RecruitingVirginia Eye Consultants
Norfolk, Virginia, United States
- Sheppard · Contact
Recruiting
Study team
Sponsor
Viatris Inc.
Study ID MR-146A-01-IJZ-1001
Frequently asked questions
The sponsor hasn't published answers to common questions for this trial.