NCT02707120

Efficacy and Safety of Plasma Rich in Growth Factors (PRGF-Endoret) Eye-drops in the Treatment of Neurotrophic Keratitis

Randomized, Parallel Groups, Multicenter and Blind to Evaluators Clinical Trial, to Evaluate the Efficacy and Safety of PRGF-Endoret Eye Drops, in Patients With Stage 2 and 3 Neurotrophic Keratitis

• Status: Withdrawn
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 0 (actual)
• Sponsor: Biotechnology Institute IMASD · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Neurotrophic keratitis (NK) is a rare degenerative corneal disease caused by altered innervation of the trigeminal nerve that leads to rupture of the corneal epithelium, the regeneration deterioration and development of corneal ulceration, their fusion, and perforation The main characteristic in the NK is a decrease or absence of corneal sensitivity.

Detailed description

The goals of treatment in the neurotrophic keratitis are prevent the progression of corneal damage, maintain eye structure and improve the transparency of the cornea. Therapy should be initiated early and based on the clinical stage of the disease because it depends on epithelial state and in the degree of corneal hypoesthesia. Plasma rich in growth factors (PRGF-Endoret) represent a new technology using autologous proteins, growth factors and biomaterials as therapeutic formulations for different regenerative purposes. Under strict pharmaceutical development, it is possible to develop biologically stable eye drops, which have been shown to be useful for treating diverse ocular surface diseases. PRGF-Endoret eye drops could be an alternative therapy for patients with NK, and thus the objective of this clinical trial is to demonstrate its possible efficacy and its safety in patients with NK in stages 2 and 3.

Conditions

• Neurotrophic Keratitis

Interventions

Type	Name	Description
DRUG	PRGF-Endoret	Active treatment will be PRP eye drops obtained by the PRGF-Endoret system.
DRUG	Artificial tears eye-drops	Artificial tear moisturizing eyedrops (Hidrathea®, Nacl 0.9 % solution without preservatives).

Timeline

• Start date: 2018-01-04
• Primary completion: 2019-01-01
• Completion: 2020-01-01
• First posted: 2016-03-14
• Last updated: 2025-02-06

Locations

4 sites across 1 country: Spain