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

Viatris Inc.

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)

Eligibility

Age range: 18+ years
Sex: All
Healthy volunteers: No

Detailed criteria

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 t…

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

Summary

Eligibility

Interventions

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