NCT07923045 · Viatris Inc.
A Phase 1/2, Single-Dose, Multicenter, Dose Escalation, Clinical Trial to Evaluate the Safety and Efficacy of MR-146: An Open-Label Part 1 in Participants With Stage 1 or 2 Neurotrophic Keratopathy and a Double-Masked Part 2 in Participants With Stage 2 Neurotrophic Keratopathy
(MR-146)
What this study is about
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)
View original scientific description
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)
Interventions
GENETIC
MR-146
gene therapy product for the treatment of stage I/II NK.
Primary outcome measures
Safety
Time frame: Week 52
To evaluate the safety of MR-146 through the incidence of Dose-Limiting Toxicities (DLTs)
Safety
Time frame: Week 52
To evaluate the safety of MR-146 through the incidence of serious adverse events.
Safety
Time frame: Week 52
To evaluate the safety of MR-146 through the incidence of adverse events.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
Exclusion criteria
- 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.
Where
- Sun City, Arizona
- Tucson, Arizona
- Glendale, California
- Loma Linda, California
- San Diego, California
- Colorado Springs, Colorado
- Louisville, Kentucky
- Fargo, North Dakota
- Portland, Oregon
- San Antonio, Texas
- Norfolk, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Nov 6, 2026 · Source of record for eligibility and locations