SEER-2 (Neurotrophic Keratopathy) - Clinical Trial

What is the Purpose of this Study?

We are doing this study to find out if an investigational drug called RGN-259 Thymosin Beta 4 eye drops solution (the study drug) is a safe and effective option for the treatment of neurotrophic keratopathy.

What is the Condition Being Studied?

Neurotrophic Keratopathy

Who Can Participate in the Study?

Adults ages 18+ who:

  • Have persistent epithelial defect in one or both eyes
  • Are diagnosed with neurotrophic keratopathy
  • Have not had any eye surgery for the last 3 months

For more information about who can be in this study, please contact the study team at DEC-RA@duke.edu.

Age Group
Adults

What is Involved?

If you choose to join the study, you will:

  • Get a random assignment (like a coin flip) to receive either the study drug or a placebo (sterile saline solution)
  • Visit our clinic at the Duke Eye Center up to 7 times
  • Keep in touch with the study team for up to 6 weeks

During the study visits, you will have eye exams and vision tests, and you will answer some questionnaires.

Study Details

Full Title
A Phase 3, Multi-Center, Randomized, Parallel, Double Masked, Placebo Controlled Clinical Study to Assess the Safety and Efficacy of 0.1% RGN-259 Ophthalmic Solution for the Treatment of Neurotrophic Keratopathy (SEER-2) - RGN-NK-302
Principal Investigator
Corneal Specialist
Protocol Number
IRB: PRO00113615
NCT: NCT05555589
Phase
Phase III
ClinicalTrials.gov
Enrollment Status
Open for Enrollment