Clinical trial NCT03084861: A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
Official title: 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
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE1
PHASE2
Conditions: Neurotrophic Keratopathy
Lead sponsor: Banc de Sang i Teixits
Sponsor class: OTHER
First posted: 2017-03-21
Enrollment: 9
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: open label
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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

Primary outcomes:
measure: Corneal lesion size
timeFrame: after 3 weeks post-treatment,
Secondary outcomes:
measure: Incidence of Adverse Events
timeFrame: From date of randomization until the date of the last visit (6 weeks post-treatment)
measure: Corneal lesion size
timeFrame: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment
measure: Stage on the corneal lesion
timeFrame: at 3 weeks post-treatment
measure: Qualitative scale of corneal sensibility
timeFrame: at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment
measure: Corneal opacity
timeFrame: at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment
measure: Visual acuity
timeFrame: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment
measure: Neurotrophic keratopathy
timeFrame: From date of randomization until the date of the last visit (6 weeks post-treatment)
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitari Germans Trias i Pujol
state: Barcelona
city: Terrassa
country: Spain
facility: Hospital Mútua de Terrassa
state: Barcelona
city: Barcelona
country: Spain
facility: Hospital de la Santa Creu i Sant Pau
state: Catalonia
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebron
state: Catalonia
city: Barcelona
country: Spain
facility: Instituto Oftalmológico Quirónsalud Barcelona
city: Barcelona
country: Spain
facility: Hospital de l'Esperança
city: Barcelona
country: Spain
facility: Institut de microcirurgia ocular IMO
city: Barcelona
country: Spain
facility: Hospital Clinic i Provincial de Barcelona
city: Girona
country: Spain
facility: Hospital Josep Trueta
city: Tarragona
country: Spain
facility: Hospital Joan XXIII
Study officials:
affiliation: Banc de Sang i Teixits
name: Sergi Querol Giner, MD PHD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.