SEER-2 NK study
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)
- Sex: Any
- Age: Adult (18 - 64), Older Adult (65+)
- Accepting Healthy People: No
- Type: Interventional / Therapeutic
- Trial Phase: Phase III
- Conditions Being Studied: Neurotrophic Keratopathy
Study Purpose
The purpose of this study is to find out the effectiveness of the (RGN-259) Thymosin Beta 4 eye drops solution in the clearing of a persistent epithelial defect (PED) (that is, consistent eye tissue breakdown) in subjects with Neurotrophic Keratopathy. RGN-259 is formulated as preservative-free, sterile eye drops and being studied to treat Neurotrophic Keratopathy. Since the tissue breakdown of the cornea is causing Neurotrophic Keratopathy, it is thought that this study treatment may help subjects with this disease by enhancing wound healing, repair and regeneration.
Who Can Participate
Age: 18 years and older
Locations
UH Cleveland Medical Center
11100 Euclid Ave
Cleveland OH, 44106
UH Landerbrook Health Center
5850 Landerbrook Dr
Mayfield Heights OH, 44124
UH Westlake Health Center
960 Clague Rd
Westlake OH, 44145
- UH IRB: STUDY20231057
- StudyID: 2023-01214
- ClinicalTrials.gov: NCT05555589
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