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

Primary Purpose

Neurotrophic Keratitis

Status

Unknown status

Phase

Phase 4

Locations

Spain

Study Type

Interventional

Intervention

PRGF-Endoret

Artificial tears eye-drops

About this trial

This is an interventional treatment trial for Neurotrophic Keratitis focused on measuring PRGF, Neurotrophic Keratitis, platelet rich plasma, PRP

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Instituto Oftalmológico Fernández-Vega
Instituto Clínico Quirúrgico de Oftalmología (ICQO)
Instituto de Microcirugía Ocular (IMO)
Hospital Ramón y Cajal

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

PRGF-Endoret eye-drops

Artificial tears eye-drops

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Percentage of patients showing complete healing of the corneal defect

Measurement of the depth of the corneal defect (mm)

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

Ocular pain with VAS scale

Osmolarity of lacrimal film

Measurement of treatment tolerance

Measurement of treatment tolerance with a 0 4 score

Adverse events

Percentage of adverse event occurrence

Full Information

NCT ID

NCT02707120

First Posted

February 29, 2016

Last Updated

July 12, 2017

Sponsor

Biotechnology Institute IMASD

1. Study Identification

Unique Protocol Identification Number

NCT02707120

Brief Title

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

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2017

Overall Recruitment Status

Unknown status

Study Start Date

January 4, 2018 (Anticipated)

Primary Completion Date

January 2019 (Anticipated)

Study Completion Date

January 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Biotechnology Institute IMASD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Neurotrophic Keratitis

Keywords

PRGF, Neurotrophic Keratitis, platelet rich plasma, PRP

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 4

Interventional Study Model

Parallel Assignment

Masking

Investigator

Allocation

Randomized

Enrollment

76 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

PRGF-Endoret eye-drops

Arm Type

Experimental

Arm Title

Artificial tears eye-drops

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

PRGF-Endoret

Intervention Description

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

Intervention Type

Drug

Intervention Name(s)

Artificial tears eye-drops

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Time Frame

4 weeks

Secondary Outcome Measure Information:

Title

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

Time Frame

2 weeks

Title

Percentage of patients showing complete healing of the corneal defect

Time Frame

4 weeks

Title

Percentage of patients showing complete healing of the corneal defect

Time Frame

2 weeks

Title

Measurement of the depth of the corneal defect (mm)

Time Frame

2 and 4 weeks

Title

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

Time Frame

2 and 4 weeks

Title

Ocular pain with VAS scale

Time Frame

2 and 4 weeks

Title

Osmolarity of lacrimal film

Time Frame

2 and 4 weeks

Title

Measurement of treatment tolerance

Description

Measurement of treatment tolerance with a 0 4 score

Time Frame

2 and 4 weeks

Title

Adverse events

Description

Percentage of adverse event occurrence

Time Frame

2 and 4 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Gorka Orive, PhD

Phone

663027696

gorka.orive@bti-implant.es

Facility Information:

Facility Name

Instituto Oftalmológico Fernández-Vega

City

Oviedo

State/Province

Asturias

Country

Spain

Facility Name

Instituto Clínico Quirúrgico de Oftalmología (ICQO)

City

Bilbao

State/Province

Bizkaia

Country

Spain

Facility Name

Instituto de Microcirugía Ocular (IMO)

City

Barcelona

Country

Spain

Facility Name

Hospital Ramón y Cajal

City

Madrid

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

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

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