A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy

A Multicenter, Randomized, Open-label, Two-arms Phase I/II Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy

This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of Neurotrophic Keratopathy (NK). Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).

Study Overview

• Status: Terminated
• Conditions: Neurotrophic Keratopathy
• Intervention / Treatment: Drug: Cord Blood Eye Drops; Drug: Conventional treatment

Detailed Description

This is a multicenter, randomized, open-label, two-arms phase I/II, clinical trial, in which 42 patients will be enrolled with the principal objective to evaluate the efficacy through changes in lesion size and, secondary, to evaluate the safety and efficacy through corneal sensibility, corneal opacity, visual acuity and complications of NK. Patients will be randomized 1:1 to receive experimental treatment (cord blood eye drops) or conventional treatment (artificial tears and therapeutic contact lens).

All patients, with conventional or experimental treatment, will be treated for 19 days. A topical antibiotic will be added too as a concomitant treatment to all treatment groups, until the injury closes or according to medical criteria.

After signing informed consent, inclusion and exclusion criteria will be assessed, and if the patient meets all the requirements, the patient will be randomized.

After initiation of the treatment, patients will be follow-up at 2-3 days and once a week for 3 weeks. A final follow-up is planned at 6 weeks.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2; Phase 1

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic i Provincial de Barcelona
  • Barcelona, Spain, 08024
    • Hospital de l'Esperança
  • Barcelona, Spain, 08017
    • Instituto Oftalmológico Quirónsalud Barcelona
  • Barcelona, Spain, 08035
    • Institut de microcirurgia ocular IMO
  • Girona, Spain, 17007
    • Hospital Josep Trueta
  • Tarragona, Spain, 43005
    • Hospital Joan XXIII
  • Barcelona
    • Badalona, Barcelona, Spain, 08916
      • Hospital Universitari Germans Trias I Pujol
    • Terrassa, Barcelona, Spain, 08221
      • Hospital Mutua De Terrassa
  • Catalonia
    • Barcelona, Catalonia, Spain, 08035
      • Hospital Vall d'Hebron
    • Barcelona, Catalonia, Spain, 08026
      • Hospital de la Santa Creu i Sant Pau

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥ 18 years old
2. NK stage 2 or 3 (Mackie classification)
3. Signed Informed Consent Form
4. The patient is able to understand the nature of the study and to participate throughout its duration

Exclusion Criteria:

1. Medical history of eye tumors
2. Active eye infection
3. Eyelid bad position or eyelid closure problems
4. Conjunctiva scarring
5. Topic chronic eye treatments with corticoids
6. Acute corneal burns (<3 months)
7. Intolerance to contact lens
8. Allergy or inability to receive concomitant treatment with Exocin®
9. Patients with immunosuppressive or chemotherapy treatment
10. Pregnant woman or woman without proper contraceptive methods according to the investigator (*), or lactating women
11. Participation in another clinical trial in the last month (*) Contraceptive methods accepted in the protocol are: hormonal, intrauterine device (IUD), barrier methods, voluntary sterilization or the patient has menopause >1 year duration

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: cord blood eye drops; Experimental drug: cord blood eye drops Description: eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives Dosage regimen: 1 drop every 2 hours Pharmaceutical form: ophthalmic preparation eye drops Presentation: batch of 19 vials of 1 mL per vial Route of administration: ophthalmic/ocular	Drug: Cord Blood Eye Drops; Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives
Active Comparator: Conventional treatment; Conventional treatment: Artificial tears Description: Lubristil ® (single dose) Dosage regimen: 1 drop every 2 hours Pharmaceutical form: ophthalmic preparation eye drops Presentation: batch of 20 or 30 vials of 0.3 mL per vial Route of administration: ophthalmic; Therapeutic Contact lens Description: Air Optix Night&Day Dosage regimen: 1 contact lens per visit Pharmaceutical form: contact lens Presentation: 1 unit per case Route of administration: ophthalmic/ocular	Drug: Conventional treatment; Artificial tears: Lubristil ®; Therapeutic Contact lens: Air Optix Night&Day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Corneal lesion size	Variation percentage in corneal lesion size	after 3 weeks post-treatment,

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of Adverse Events	Safety evaluation through laboratory data and adverse events	From date of randomization until the date of the last visit (6 weeks post-treatment)
Corneal lesion size	Variation percentage in corneal lesion size	at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment
Stage on the corneal lesion	Changes stage on the corneal lesion (cured, stage 1, stage 2, stage 3) from baseline	at 3 weeks post-treatment
Qualitative scale of corneal sensibility	Changes in qualitative scale of corneal sensibility (normoesthesia, hypoesthesia, anesthesia)	at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment
Corneal opacity	Changes on corneal opacity from baseline (not response, improvement, worse)	at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment
Visual acuity	Line variation in relation to visual acuity	at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment
Neurotrophic keratopathy	Number of neurotrophic keratopathy complications	From date of randomization until the date of the last visit (6 weeks post-treatment)

Collaborators and Investigators

• Sponsor: Banc de Sang i Teixits
• Investigators: Principal Investigator: Sergi Querol Giner, MD PHD, Banc de Sang i Teixits

Publications and helpful links

General Publications

• Samarkanova D, Martin S, Bisbe L, Puig J, Calatayud-Pinuaga M, Rodriguez L, Azqueta C, Coll R, Casaroli-Marano R, Madrigal A, Rebulla P, Querol S; Barcelona CBED Study Group (Appendix I). Clinical evaluation of allogeneic eye drops from cord blood platelet lysate. Blood Transfus. 2021 Jul;19(4):347-356. doi: 10.2450/2020.0130-20. Epub 2020 Oct 9.

Study record dates

Study Major Dates

• Study Start (Actual): February 24, 2017
• Primary Completion (Actual): March 12, 2020
• Study Completion (Actual): March 12, 2020

Study Registration Dates

• First Submitted: March 8, 2017
• First Submitted That Met QC Criteria: March 14, 2017
• First Posted (Actual): March 21, 2017

Study Record Updates

• Last Update Posted (Actual): October 27, 2020
• Last Update Submitted That Met QC Criteria: October 23, 2020
• Last Verified: October 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pharmaceutical Solutions; Ophthalmic Solutions
• Other Study ID Numbers: I.2016.010

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No