Ongoing Clinical Trials for Neurotrophic Keratopathy
There are currently 2 ongoing clinical trials testing new eye drop treatments for neurotrophic keratopathy, a rare condition where the cornea loses its sensitivity and ability to heal properly. These studies are being conducted across several European countries, including Italy, Spain, Poland, and Germany, and are investigating whether a medication called RGN-259 (Timbetasin acetate) can help heal persistent corneal defects in patients with this condition.
Clinical trial locations
- Germany
- Italy
- Poland
- Spain
Study on the Safety and Effectiveness of Timbetasin Acetate Eye Drops for Patients with Neurotrophic Keratopathy
This study is testing a new eye drop treatment called RGN-259, which contains the active ingredient Timbetasin acetate at a concentration of 0.1%. The medication is designed to help heal persistent defects on the cornea by promoting cell growth and repair.
Main inclusion criteria: To participate in this trial, you must be at least 18 years old. You need to have a persistent epithelial defect (a non-healing area on the cornea surface) in at least one eye that has not improved after one week of standard treatment with lubricating eye drops, antibiotics, or other conventional methods. The defect must be at least 1 mm in size, and you must have stage 2 or 3 neurotrophic keratopathy confirmed by the study doctor. Your corneal sensitivity must be reduced, as measured by a special instrument called a Cochet-Bonnet aesthesiometer. Your vision in the affected eye should be 75 or fewer letters on a standard eye chart (ETDRS protocol). Women who can become pregnant must use effective birth control from 4 weeks before starting the treatment until 12 weeks after the last dose.
Main exclusion criteria: You cannot participate if you have other eye conditions that could interfere with the study results, if you have had eye surgery within the last 3 months, or if you are currently using other eye medications that could affect the study. You also cannot participate if you have a history of allergic reactions to the study medication or similar treatments, if you are pregnant or breastfeeding, if you have participated in another clinical trial within the last 30 days, or if you have any serious health condition that could affect your participation.
Focus and goals: The main goal of this study is to determine whether RGN-259 eye drops are safe and effective at healing persistent corneal defects. The trial compares the treatment with a placebo (inactive eye drops) to see if the medication truly makes a difference. Participants will use the eye drops regularly and attend scheduled check-ups to monitor healing progress. The primary endpoint is achieving complete healing of the defect by Day 29, meaning the lesion size is reduced to 0 mm. Doctors will measure the defect size using a special fluorescent dye that highlights damaged areas of the cornea under blue light. They will also assess improvements in visual acuity, corneal sensitivity, and overall symptom severity throughout the study period.
Study on the Safety and Effectiveness of RGN-259 Eye Drops for Patients with Neurotrophic Keratopathy
This trial is evaluating RGN-259, also known as Timbetasin acetate ophthalmic solution 0.1%, as a treatment for healing the cornea in patients whose eyes have lost normal sensitivity and healing ability. The eye drops aim to promote natural repair processes in the cornea.
Main inclusion criteria: Eligible participants must be at least 18 years old and have a persistent epithelial defect in one or both eyes that has not healed after one week of standard treatments such as non-preserved eye lubricants, antibiotics, oral doxycycline, patching, amniotic membrane, serum tears, or therapeutic contact lenses. You must have stage 2 or 3 neurotrophic keratopathy with a defect measuring at least 1 mm at its longest point. Corneal sensitivity must be reduced to 40 mm or less as measured by the Cochet-Bonnet aesthesiometer. Your best corrected visual acuity must be 75 letter counts or less on the ETDRS eye chart. Women of childbearing potential must use acceptable birth control methods for at least 4 weeks before starting the treatment and until 12 weeks after the last dose, and must have a negative pregnancy test during screening.
Main exclusion criteria: You cannot participate if you are younger than 18 years old, if you have not been diagnosed with neurotrophic keratopathy, or if you are part of a vulnerable population unable to provide informed consent.
Focus and goals: This study aims to determine both the safety and effectiveness of RGN-259 compared to a placebo. The trial is designed as a double-masked study, meaning neither participants nor researchers know who receives the actual treatment versus the placebo, ensuring unbiased results. Participants will use the eye drops for up to four weeks and attend regular check-ups to monitor corneal healing and assess any changes in their eye condition. During follow-up visits, doctors will measure the size of the eye defect using fluorescein dye under blue light, re-evaluate eye sensitivity and vision, and record any side effects or changes in health. The final assessment includes a comprehensive eye examination to determine overall healing and evaluate the treatment’s safety and effectiveness profile.
Summary
Both ongoing clinical trials are testing the same investigational medication, RGN-259 (Timbetasin acetate), in a 0.1% ophthalmic solution formulation. The studies are being conducted across multiple European countries, with trials taking place in Italy, Spain, Poland, and Germany. This geographic distribution suggests a coordinated international research effort to evaluate this potential new treatment option.
The trials follow similar designs, comparing the active treatment against a placebo to determine whether the medication truly helps heal persistent corneal defects. Both studies target patients with stage 2 or 3 neurotrophic keratopathy who have not responded to conventional treatments. The primary focus is on achieving complete healing of corneal defects within approximately four weeks of treatment, while also monitoring safety, changes in visual acuity, and improvements in corneal sensitivity.
If you are interested in participating in either of these trials, you should discuss with your eye doctor whether you meet the eligibility criteria and which trial location might be most accessible for you.
