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

NCT02707120 | Withdrawn Phase 4

• 1 other identifier: BTI-011-EC/15/QUER
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 4

Brief 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.

Conditions

Neurotrophic Keratitis

Keywords

PRGF, Neurotrophic Keratitis, platelet rich plasma, PRP

Outcome Measures

Primary Outcomes (1)

• Percentage of patients with a reduction of corneal defect of >50%

  4 weeks

Secondary Outcomes (9)

• Percentage of patients with a reduction of corneal defect of >50%

  2 weeks

• Percentage of patients showing complete healing of the corneal defect

  4 weeks

• Percentage of patients showing complete healing of the corneal defect

  2 weeks

• Measurement of the depth of the corneal defect (mm)

  2 and 4 weeks

• Changes in percentage in Best corrected visual acuity (BCVA LogMAR)

  2 and 4 weeks

Study Arms (2)

PRGF-Endoret eye-drops

EXPERIMENTAL

Drug: PRGF-Endoret

Artificial tears eye-drops

ACTIVE COMPARATOR

Drug: Artificial tears eye-drops

Interventions

PRGF-Endoret DRUG

Active treatment will be PRP eye drops obtained by the PRGF-Endoret system.

PRGF-Endoret eye-drops

Artificial tears eye-drops DRUG

Artificial tear moisturizing eyedrops (Hidrathea®, Nacl 0.9 % solution without preservatives).

Artificial tears eye-drops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Biotechnology Institute IMASD: lead

Study Sites (4)

Instituto Clínico Quirúrgico de Oftalmología (ICQO)

Bilbao, Bizkaia, Spain

Location

Instituto Oftalmológico Fernández-Vega

Oviedo, Principality of Asturias, Spain

Location

Instituto de Microcirugía Ocular (IMO)

Barcelona, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 29, 2016
• First Posted: March 14, 2016
• Study Start: January 4, 2018
• Primary Completion: January 1, 2019
• Study Completion: January 1, 2020
• Last Updated: February 6, 2025

Record last verified: 2025-02

Locations

ES (4)