SEER-3
Research type
Research Study
Full title
SEER-3: 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
IRAS ID
1006964
Contact name
Sajjad Ahmad
Contact email
Sponsor organisation
ReGenTree LLC
Eudract number
2022-502697-16
Research summary
The purpose of this study is to find out the safety and efficacy 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 (also called neurotrophic keratitis). The study will be conducted in Europe, United Kingdom and United States of America and will include 70 patients. Neurotrophic Keratopathy is a rare disease of the cornea that occurs when the sensory nerves to the cornea do not function properly. In people with Neurotrophic Keratopathy, the corneal epithelium (that is, layer of eye tissue of the cornea) may break down, affecting vision and causing corneal ulceration. 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. The use of RGN-259 (the investigational drug) eye drops solution in this study is investigational and it is not approved in the world. Patients who are 18 years old or older can participate to the study, provided that they are diagnosed with an ulceration of the cornea which is measuring at least 1mm. The study will require 4 weeks of treatment in which the study drug will be administerd once per week at site and then daily at home; then there will be a follow up period of 2 weeks in which the patinet will be requested to return to the site once per week.
REC name
London - Riverside Research Ethics Committee
REC reference
23/LO/0218
Date of REC Opinion
11 Oct 2023
REC opinion
Further Information Unfavourable Opinion