The first patient has been enrolled in the phase I/II REPARO study, the first international clinical trial evaluating the ophthalmological use of a topical solution of recombinant human Nerve Growth Factor (rhNGF) for the treatment of moderate to severe neurotrophic keratitis (NK). The drug was developed on the basis of the experimental studies conducted by the late Professor Rita Levi Montalcini, who was awarded the Nobel Prize for her discovery of this signalling protein involved in the development of the nervous system.
The first patient with this rare, sight-threatening degenerative disease of the cornea, which afflicts one in 10,000 people throughout the world, was recruited at San Raffaele Hospital in Milan. The clinical trial is sponsored by Dompé, one of Italy's leading biopharmaceutical companies, dedicated to finding innovative therapeutic solutions for diseases that have a high social impact in the areas of diabetes, ophthalmology and oncology.
The REPARO Study is randomised, double-masked, placebo-controlled trial that will enrol patients with grade 2 (persistent epithelial defect) or grade 3 lesions (corneal ulcer) NK who do not respond to currently available medications in nine countries. The primary objective of the trial is to evaluate the safety and efficacy of two doses of a rhNGF (10 µg/ml and 20 µg/ml) solution administered topically in the form of eye drops. It is planned to enrol at least 174 patients, who will be randomized to one of the two doses or placebo during the 8 week controlled treatment period. There after follow-up will last at least 48 weeks. The secondary objectives of the trial are to evaluate the duration of corneal healing, improvement in visual acuity and corneal sensitivity.