Neurotrophic KeratopathyPhase 1/2NCT03084861
A Clinical Trial to Asses Efficacy and Safety of Cord Blood Eye Drops in Neurotrophic Keratopathy
A Phase 1/2 study testing Cord Blood Eye Drops and Conventional treatment in people with Neurotrophic Keratopathy, run by Banc de Sang i Teixits at 10 sites in Spain.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Neurotrophic Keratopathy
- What is being tested?
- Cord Blood Eye Drops and Conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 10 sitesSpain
- Study dates
- 24 Feb 2017to 12 Mar 2020
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old
- NK stage 2 or 3 (Mackie classification)
- Signed Informed Consent Form
- The patient is able to understand the nature of the study and to participate throughout its duration
Who cannot join
- Medical history of eye tumors
- Active eye infection
- Eyelid bad position or eyelid closure problems
- Conjunctiva scarring
- Topic chronic eye treatments with corticoids
- Acute corneal burns (<3 months)
Show all 11Show fewer
- Intolerance to contact lens
- Allergy or inability to receive concomitant treatment with Exocin®
- Patients with immunosuppressive or chemotherapy treatment
- Pregnant woman or woman without proper contraceptive methods according to the investigator (*), or lactating women
- 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
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
Spain10 sites
Hospital Universitari Germans Trias i Pujol
Badalona, Barcelona, 08916
Hospital de la Santa Creu i Sant Pau
Barcelona, Catalonia, 08026
Hospital Vall d'Hebron
Barcelona, Catalonia, 08035
Instituto Oftalmológico Quirónsalud Barcelona
Barcelona, 08017
Hospital de l'Esperança
Barcelona, 08024
Institut de microcirurgia ocular IMO
Barcelona, 08035
Hospital Clinic i Provincial de Barcelona
Barcelona, 08036
Hospital Josep Trueta
Girona, 17007
Hospital Joan XXIII
Tarragona, 43005
Hospital Mútua de Terrassa
Terrassa, Barcelona, 08221
About this study
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
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).
Read the 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.
- Conditions
- Neurotrophic Keratopathy
- Being tested
- Cord Blood Eye Drops, Conventional treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cord Blood Eye DropsDrug
Eye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives
Conventional treatmentDrug
- Artificial tears: Lubristil ®
- Therapeutic Contact lens: Air Optix Night\&Day
| Study group | Role | What they receive |
|---|---|---|
| cord blood eye drops | Experimental | 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 Receives: Drug: Cord Blood Eye Drops |
| Conventional treatment | Active comparator | Conventional treatment:
1. 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
2. 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 Receives: Drug: Conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Corneal lesion size
Variation percentage in corneal lesion size
Measured: after 3 weeks post-treatment,
Secondary outcomes (7)
Incidence of Adverse Events
Safety evaluation through laboratory data and adverse events
Measured: From date of randomization until the date of the last visit (6 weeks post-treatment)
Corneal lesion size
Variation percentage in corneal lesion size
Measured: 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
Measured: at 3 weeks post-treatment
Qualitative scale of corneal sensibility
Changes in qualitative scale of corneal sensibility (normoesthesia, hypoesthesia, anesthesia)
Measured: 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)
Measured: 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
Measured: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment
Neurotrophic keratopathy
Number of neurotrophic keratopathy complications
Measured: From date of randomization until the date of the last visit (6 weeks post-treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2017
- Study start24 Feb 2017
- Primary completion12 Mar 2020
- Study completion12 Mar 2020
Why it stopped: Low recruitment. No safety issue associated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Neurotrophic KeratopathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- open label
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Banc de Sang i Teixits
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sergi Querol Giner, MD PHD, Principal investigator, Banc de Sang i Teixits
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03084861
- Sponsor's protocol ID
- I.2016.010
- Status last verified
- Oct 2020
- First submitted
- 8 Mar 2017
- Last updated
- 27 Oct 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 33085593
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03084861
- Acronym / sponsor ID
- I.2016.010
- Conditions
- Neurotrophic Keratopathy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Low recruitment. No safety issue associated.
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Banc de Sang i TeixitsUniversity, hospital or other
- Study start
- 24 Feb 2017 (actual)
- Primary completion
- 12 Mar 2020 (actual)
- Study completion
- 12 Mar 2020 (actual)
- First posted
- 21 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- open label
| Arm | Type | Receives |
|---|---|---|
| cord blood eye drops | Experimental | Drug: Cord Blood Eye DropsExperimental 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 |
| Conventional treatment | Active comparator | Drug: Conventional treatmentConventional treatment: 1. 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 2. 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old
- NK stage 2 or 3 (Mackie classification)
- Signed Informed Consent Form
- The patient is able to understand the nature of the study and to participate throughout its duration
Key exclusion criteria (11 listed)
- Medical history of eye tumors
- Active eye infection
- Eyelid bad position or eyelid closure problems
- Conjunctiva scarring
- Topic chronic eye treatments with corticoids
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cord Blood Eye DropsEye drops plasma from cord blood diluted v/v with Plasmalyte®, without antimicrobial preservatives | Drug | cord blood eye drops |
| Conventional treatment1. Artificial tears: Lubristil ® 2. Therapeutic Contact lens: Air Optix Night\&Day | Drug | Conventional treatment |
Primary outcome
Corneal lesion size
Time frame: after 3 weeks post-treatment,
Variation percentage in corneal lesion size
7 secondary outcomes
Incidence of Adverse Events
Time frame: From date of randomization until the date of the last visit (6 weeks post-treatment)
Corneal lesion size
Time frame: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment
Stage on the corneal lesion
Time frame: at 3 weeks post-treatment
Qualitative scale of corneal sensibility
Time frame: at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment
Corneal opacity
Time frame: at 2-3 days post-treatment and at 1, 2, 3 and 6 weeks post-treatment
Visual acuity
Time frame: at 2-3 days post-treatment and at 1, 2 and 6 weeks post-treatment
Neurotrophic keratopathy
Time frame: From date of randomization until the date of the last visit (6 weeks post-treatment)
Results and safety
The study was stopped early (reason given: Low recruitment. No safety issue associated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2020.
- Derived from this study: PubMed 33085593Samarkanova 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sergi Querol Giner, MD PHD principal investigator
Banc de Sang i Teixits
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Cord Blood Eye Drops and Conventional treatment in people with Neurotrophic Keratopathy, run by Banc de Sang i Teixits at 10 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Oct 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Low recruitment. No safety issue associated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Corneal lesion size (time frame: after 3 weeks post-treatment,). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03084861, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2020.