Neurotrophic KeratopathyPhase 1/2MR-146NCT07923045
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
A Phase 1/2 study testing MR-146 in people with Neurotrophic Keratopathy, run by Viatris Inc. at 11 sites in United States.
Trial summary
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) Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotrophic Keratopathy
- What is being tested?
- MR-146
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 11 sitesUnited States
- Study dates
- Nov 2026to Nov 2028
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Show all 11Show fewer
- 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.
Trial locations and contacts
11 sites in 1 country. Contact the study team or a site near you to ask about taking part.
11 sites in 1 country
United States11 sites, 11 recruiting
- Recruiting
Vision Institute
Colorado Springs, Colorado, 80907
Simmons
- Recruiting
3RP (Red River Research Partners)
Fargo, North Dakota, 58103
Keating
- Not yet recruiting
Global Research Management
Glendale, California, 91204
El-Harazi
- Recruiting
Loma Linda University Eye Institute
Loma Linda, California, 92354
Affeldt
- Recruiting
Butchertown Clinical Trials
Louisville, Kentucky, 40206
Pattar
- Recruiting
Virginia Eye Consultants
Norfolk, Virginia, 23502
Sheppard
- Recruiting
EyeHealth Northwest
Portland, Oregon, 97225
Holland
- Recruiting
Stuart A. Terry Eye Associates
San Antonio, Texas, 78212
Alsheikh
- Recruiting
NVision
San Diego, California, 92117
Pillar
- Recruiting
Horizon Eye/DocTrials
Sun City, Arizona, 85351
Cason
- Recruiting
Nvision
Tucson, Arizona, 85712
Villavicencio
About this study
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)
- Conditions
- Neurotrophic Keratopathy
- Being tested
- MR-146
- Keywords
- NK, neurotrophic keratopathy, neurotrophic keratitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MR-146Genetic
gene therapy product for the treatment of stage I/II NK.
| Study group | Role | What they receive |
|---|---|---|
| MR-146 (Low) | Experimental | Participants will receive a single low dose of MR-146 administered via an intralacrimal gland injection Receives: Genetic: MR-146 |
| MR-146 (mid) | Experimental | participants will receive a single mid-level dose of MR-146 administered via an intralacrimal gland injection Receives: Genetic: MR-146 |
| MR-146 (high) | Experimental | participants will receive a single high dose of MR-146 administered via an intralacrimal gland injection Receives: Genetic: MR-146 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety
To evaluate the safety of MR-146 through the incidence of Dose-Limiting Toxicities (DLTs)
Measured: Week 52
Safety
To evaluate the safety of MR-146 through the incidence of serious adverse events.
Measured: Week 52
Safety
To evaluate the safety of MR-146 through the incidence of adverse events.
Measured: Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2026
- Study startNov 2026 (estimated)
- Primary completion30 Nov 2027 (estimated)
- Study completionNov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Neurotrophic KeratopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Viatris Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07923045
- Sponsor's protocol ID
- MR-146A-01-IJZ-1001
- Acronym
- MR-146
- Status last verified
- Nov 2026
- First submitted
- 2 Nov 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07923045
- Acronym / sponsor ID
- MR-146 / MR-146A-01-IJZ-1001
- Conditions
- Neurotrophic Keratopathy
- Keywords
- NK, neurotrophic keratopathy, neurotrophic keratitis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Viatris Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2026 (estimated)
- Primary completion
- 30 Nov 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 6 Nov 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MR-146 (Low) | Experimental | Genetic: MR-146Participants will receive a single low dose of MR-146 administered via an intralacrimal gland injection |
| MR-146 (mid) | Experimental | Genetic: MR-146participants will receive a single mid-level dose of MR-146 administered via an intralacrimal gland injection |
| MR-146 (high) | Experimental | Genetic: MR-146participants will receive a single high dose of MR-146 administered via an intralacrimal gland injection |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (11 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MR-146gene therapy product for the treatment of stage I/II NK. | Genetic | MR-146 (Low), MR-146 (high), MR-146 (mid) |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing MR-146 in people with Neurotrophic Keratopathy, run by Viatris Inc. at 11 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jason Dierkhising (1707-484-1365, patientrecruitment@oraclinical.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety (time frame: Week 52). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.