Recruiting
Phase 1
Phase 2

MR-146

Sponsor:

Viatris Inc.

Code:

NCT07923045

Conditions

Neurotrophic Keratopathy

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

MR-146

Study Details

Brief 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)

Conditions

Neurotrophic Keratopathy

Study ID

NCT07923045

Start date

Nov, 2026

Status verified date

Nov, 2026

Completion date

Nov, 2028

Anticipated

Primary completion date

Nov 30, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

18 participants

Anticipated

Allocation

Non randomized

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: MR-146 (Low)

Participants will receive a single low dose of MR-146 administered via an intralacrimal gland injection

experimental: MR-146 (mid)

participants will receive a single mid-level dose of MR-146 administered via an intralacrimal gland injection

experimental: MR-146 (high)

participants will receive a single high dose of MR-146 administered via an intralacrimal gland injection

Interventions

MR-146

gene therapy product for the treatment of stage I/II NK.

Primary outcome measure

  • Safety [ Time Frame: Week 52 ]
  • Safety [ Time Frame: Week 52 ]
  • Safety [ Time Frame: Week 52 ]

Central Contacts and Locations

Central contacts

Locations

Horizon Eye/DocTrials

Recruiting

Sun City, Arizona, United States, 85351

Nvision

Recruiting

Tucson, Arizona, United States, 85712

Loma Linda University Eye Institute

Recruiting

Loma Linda, California, United States, 92354

NVision

Recruiting

San Diego, California, United States, 92117

Vision Institute

Recruiting

Colorado Springs, Colorado, United States, 80907

Butchertown Clinical Trials

Recruiting

Louisville, Kentucky, United States, 40206

3RP (Red River Research Partners)

Recruiting

Fargo, North Dakota, United States, 58103

EyeHealth Northwest

Recruiting

Portland, Oregon, United States, 97225

Stuart A. Terry Eye Associates

Recruiting

San Antonio, Texas, United States, 78212

Virginia Eye Consultants

Recruiting

Norfolk, Virginia, United States, 23502

More Information

Sponsor

Viatris Inc.

Last update posted

Nov 6, 2026

Last verified

Nov, 2026

Keywords

  • NK
  • neurotrophic keratopathy
  • neurotrophic keratitis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-11-07. This information was provided to ClinicalTrials.gov by Viatris Inc. on 2026-11-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.