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

Neurotrophic Keratitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02707120
• Other study ID #: BTI-011-EC/15/QUER
• Status: Not yet recruiting
• Phase: Phase 4
• First received: February 29, 2016
• Last updated: July 12, 2017
• Start date: January 4, 2018
• Est. completion date: January 2020

Study information

• Verified date: July 2017
• Source: Biotechnology Institute IMASD
• Contact: Gorka Orive, PhD
• Phone: 663027696
• Email: gorka.orive[@]bti-implant.es
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 76
• Est. completion date: January 2020
• Est. primary completion date: January 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients aged 18 or over.

• With neurotrophic keratitis at stages 2 or 3 affecting only one eye.

• Persistent epithelial defect or corneal ulcer of at least 2 weeks duration resistant to one or more traditional non-surgical treatments .

• Corneal sensitivity reduction test in the area of the persistent epithelial defect or corneal ulcer and out of the defect area in at least one corneal quadrant.

• No objective clinical evidence of improvement in the two weeks prior to enrollment.

• Patients who have previously read and signed the informed consent.

Exclusion Criteria:

• Patients with neurotrophic keratitis stages 2 or 3 that affects both eyes.

• With active ocular infection or inflammation not related to the neurotrophic keratitis

• Any other eye disease that requires of topical ocular treatment in the affected eye during study.

• Patients with severe vision loss

• Patients with severe blepharitis and/or severe Meibomian glands disease

• History of eye surgery in the three months prior to enter the study, or patients who plan to undergo surgery.

• Having received previously surgical procedures for the treatment of NK.

• Use of therapeutic contact lenses or for refractive correction during study.

• Patients with punctual occlusion or insertion of punctual plugs previous to the study

• Evidence of corneal ulcer affecting the corneal stroma or cornea perforation.

• Presence of any disorder or ocular or systemic disease that could limit the treatment effectiveness or its evaluation,

• Any need of change (at that time or planned) in the dose of systemic drugs known to disrupt the functioning of the trigeminal nerve

• Known hypersensitivity to any of the procedural compounds (eg. fluoresceine).

• Presence of blood disorders associated with platelet disorders or clotting, or receiving anticoagulants drugs or antiplatelet agents.

• Patients with positive result in one of the serological tests for syphilis, Hepatitis B-C or AIDS I / II.

• Patient in current treatment for their pathology already well managed.

• Use of any investigational drug within 4 weeks prior to the screening visit.

• Pregnant women or intended to be pregnant.

• Participating in another clinical trial.

Related Conditions & MeSH terms

• Keratitis
• Neurotrophic Keratitis

Intervention

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

Locations

Country	Name	City	State
Spain	Instituto de Microcirugía Ocular (IMO)	Barcelona
Spain	Instituto Clínico Quirúrgico de Oftalmología (ICQO)	Bilbao	Bizkaia
Spain	Hospital Ramón y Cajal	Madrid
Spain	Instituto Oftalmológico Fernández-Vega	Oviedo	Asturias

Sponsors (1)

Lead Sponsor	Collaborator
Biotechnology Institute IMASD

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage of patients with a reduction of corneal defect of >50%		4 weeks
Secondary	Percentage of patients with a reduction of corneal defect of >50%		2 weeks
Secondary	Percentage of patients showing complete healing of the corneal defect		4 weeks
Secondary	Percentage of patients showing complete healing of the corneal defect		2 weeks
Secondary	Measurement of the depth of the corneal defect (mm)		2 and 4 weeks
Secondary	Changes in percentage in Best corrected visual acuity (BCVA LogMAR)		2 and 4 weeks
Secondary	Ocular pain with VAS scale		2 and 4 weeks
Secondary	Osmolarity of lacrimal film		2 and 4 weeks
Secondary	Measurement of treatment tolerance	Measurement of treatment tolerance with a 0 4 score	2 and 4 weeks
Secondary	Adverse events	Percentage of adverse event occurrence	2 and 4 weeks