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Clinical Trial 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.


Clinical Trial 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. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT02707120
Study type Interventional
Source Biotechnology Institute IMASD
Contact Gorka Orive, PhD
Phone 663027696
Email gorka.orive@bti-implant.es
Status Not yet recruiting
Phase Phase 4
Start date January 4, 2018
Completion date January 2020

See also
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Terminated NCT03037450 - Miniinvasive Corneal Neurotization. A Pilot Study. N/A
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Completed NCT01756456 - Evaluation of Safety and Efficacy of rhNGF in Patients With Stage 2 and 3 Neurotrophic Keratitis. Phase 1/Phase 2
Completed NCT02227147 - Evaluation of Efficacy of 20 µg/ml rhNGF New Formulation (With Anti-oxidant) in Patients With Stage 2 and 3 NK Phase 2
Recruiting NCT05552261 - DEFENDO Long Term Follow-up Study in Stage 1 NK Patients
Recruiting NCT04909450 - Study to Evaluate the Safety and Efficacy of CSB-001 Ophthalmic Solution 0.1% in Neurotrophic Keratitis Subjects Phase 1/Phase 2
Active, not recruiting NCT06411145 - Open-label Trial to Evaluate Efficacy and Safety of rhNGF on Corneal Thickness Via AS-OCT in Neurotrophic Keratitis Phase 4