Blood Based Eyedrops From Different Sources in the Treatment of Severe Keratopathy

Sponsor

IRCCS Azienda Ospedaliero-Universitaria di Bologna (Other)

Overall Status

Unknown status

CT.gov ID

NCT03064984

Collaborator

University of Bologna (Other), Regione Emilia-Romagna (Other), Centro Nazionale Sangue (Other)

Enrollment

Locations

Arms

Anticipated Duration (Months)

Patients Per Site

2.5

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Topical preparations (eye drops) derived from the blood have become a relatively common treatment for more advanced forms of keratopathy. The purpose of this study is to evaluate the effect of two blood components from donors (serum cord blood and serum from adult subject donor peripheral blood) in the treatment of severe keratopathies.

Condition or Disease	Intervention/Treatment	Phase
Keratopathy Sjogren's Syndrome GVHD - Graft-Versus-Host Disease	Other: CBS eyedrops Other: PBS eyedrops	N/A

Detailed Description

The rationale for the use of eye drops prepared from the blood as a source is mainly based on their content in growth factors (Growth factors, GF), which play an important role in regulation of many processes involved in normal healing of damaged corneal epithelium . The most used product so far is the eye drop prepared from serum (Autologous Serum, AS) or from platelet-rich plasma (Plasma Rich Platelet, PRP) of peripheral blood taken from the patients themselves. More recently, treatments were introduced by homologous sources that undoubtedly offer advantages as compared to autologous sources. In particular the homologous sources show:

not invasiveness to the patient, who could in time not like the repeated withdrawals
applicability even in patients with underlying systemic conditions. They may contain in their blood, among others, higher levels of pro-inflammatory factors, with the consequence of poor and inappropriate final product to be prepared and delivered to the eye
reliability, since the homologous products can be prepared, controlled, also validated under the microbiological profile and standardized advance, then kept frozen until the dispensation
conceptually unlimited availability of the product to be dispensed
versatility of therapeutic indications, based on different GF levels which are estimated in advance

The purpose of this study is to evaluate the effect of two products derived from two different blood sources (cord blood collected at birth from placenta umbilical veins and adult subject donor peripheral blood) in the treatment of severe keratopathies.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

60 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

This is a double-blind, interventional clinical study, randomized, multicenter. The treatments under study comprise topical products prepared from two different sources: umbilical cord blood collected at birth and adult subject donor peripheral blood. The products are prepared, standardized, controlled and sealed in anonymous frozen vials in the Transfusional Service, partner in the study. The study consists of two phases: Phase 1 is runned for one month treatment. The assignment of the treatment in Phase 1 is performed through a computer based randomization process, blind to the patient and the clinician, only known to the Transfusion Service personnel. The patient enter Phase 2 only in case of a corneal epithelial damage relapse taking place within two months after the end of Phase 1, and the treatment assigned belongs to the remaining arm. In this case also, the treatment is only known to the Transfusion Service personnel, trained to keep data aside.This is a double-blind, interventional clinical study, randomized, multicenter. The treatments under study comprise topical products prepared from two different sources: umbilical cord blood collected at birth and adult subject donor peripheral blood. The products are prepared, standardized, controlled and sealed in anonymous frozen vials in the Transfusional Service, partner in the study. The study consists of two phases: Phase 1 is runned for one month treatment. The assignment of the treatment in Phase 1 is performed through a computer based randomization process, blind to the patient and the clinician, only known to the Transfusion Service personnel. The patient enter Phase 2 only in case of a corneal epithelial damage relapse taking place within two months after the end of Phase 1, and the treatment assigned belongs to the remaining arm. In this case also, the treatment is only known to the Transfusion Service personnel, trained to keep data aside.

Masking:

Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Masking Description:

The products under study are prepared, standardized, controlled and sealed in anonymous frozen vials in the Transfusional Service of the S.Orsola-Malpighi Hospital, our partner and collaborator in the study. The products have same physical and colour characteristics and cannot be visually recognized. Boxes containing the vials report a code of assignement only known by the Transfusion service personnel.

Primary Purpose:

Treatment

Official Title:

Blood Based Eyedrops From Different Sources in the Treatment of Severe Keratopathy - A Randomized Clinical Trial

Actual Study Start Date :

Jan 30, 2017

Anticipated Primary Completion Date :

Jun 30, 2017

Anticipated Study Completion Date :

Sep 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: CBS eyedrops Eyedrops prepared from CBS (Cord Blood Serum), and administered 1 drop/each eye/8 times per day, for 30 days	Other: PBS eyedrops PBS eyedrops (prepared from adult peripheral blood serum) will be provided as frozen vials containing 0.8 ml of the product and will be administered at a regimen of 1 drop / 8 times day / each eye during the waking period, with the last administration to take before bedtime.
Active Comparator: PBS eyedrops Eyedrops prepared from PBS (Peripheral Blood Serum) from adult donor subjects, administered 1 drop/each eye/8 times per day, for 30 days	Other: CBS eyedrops CBS eyedrops (prepared from umbilical cord blood serum) will be provided as frozen vials containing 0.8 ml of the product and will be administered at a regimen of 1 drop / 8 times day / each eye during the waking period, with the last administration to take before bedtime.

Arm

Intervention/Treatment

Active Comparator: CBS eyedrops

Eyedrops prepared from CBS (Cord Blood Serum), and administered 1 drop/each eye/8 times per day, for 30 days

Other: PBS eyedrops

PBS eyedrops (prepared from adult peripheral blood serum) will be provided as frozen vials containing 0.8 ml of the product and will be administered at a regimen of 1 drop / 8 times day / each eye during the waking period, with the last administration to take before bedtime.

Active Comparator: PBS eyedrops

Eyedrops prepared from PBS (Peripheral Blood Serum) from adult donor subjects, administered 1 drop/each eye/8 times per day, for 30 days

Other: CBS eyedrops

CBS eyedrops (prepared from umbilical cord blood serum) will be provided as frozen vials containing 0.8 ml of the product and will be administered at a regimen of 1 drop / 8 times day / each eye during the waking period, with the last administration to take before bedtime.

Outcome Measures

Primary Outcome Measures

Variation of corneal epithelium damage [30 days]
The effect of the treatment(s) will be evaluated by measuring the area of damaged corneal epithelium (calculated as the mm2 of damaged epithelium) after treatment as compared to baseline, and defined as 1. complete healing : no detection of damaged area; 2. Partial healing : reduction of the damaged corneal area after treatment as compared to baseline ; 3. No improvement : same damaged corneal epithelial area in mm2 at baseline and after treatment; 4. Worsening : damaged corneal epithelial area in mm2 after treatment larger than at baseline

Secondary Outcome Measures

Variation of subjective sensation of discomfort [30 days]
The effect of the treatment(s) will be evaluated by measuring the subjective discomfort (expressed with the OSDI score) after treatment as compared to baseline and defined as 1. Disappearance of discomfort: OSDI score < 6/100; 2. Reduction of discomfort: reduction of the OSDI score after treatment as compared to baseline ; 3. No improvement : same values for OSDI score after treatment as detected in baseline; 4. Worsening : score for OSDI score after treatment higher than that detected at baseline

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

diagnosis of severe dry eye , scored as level severity 3 according to the Dry Eye WorkShop grade (DEWS, Ocular Surf 2007)
corneal epithelial damage, stained with fluorescein as vital dye, NEI (national Eye Institute) score> 6 (estimated with imageJ software) damage coverage> 25% of total corneal area
good general health condition
ability to adhere to treatment and to the procedures provided by the study

Exclusion Criteria:

concurrent treatment with hypotensive drugs
ocular surgery in the 12 months preceding enrollment .

Contacts and Locations

Locations

	Site	City	Country	Postal Code
1	AOU Bologna, Ophthalmology Unit	Bologna	Italy	40138
2	Ospedale S.Maria Nuova - IRCCS - Ophthalmology Unit	Reggio Emilia	Italy	42123
3	Ospedale degli Infermi, Ophtalmology Unit	Rimini	Italy	47900

Sponsors and Collaborators

IRCCS Azienda Ospedaliero-Universitaria di Bologna
University of Bologna
Regione Emilia-Romagna
Centro Nazionale Sangue

Investigators

Principal Investigator: Emilio C Campos, MD, AOU Bologna, University of Bologna

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:

Emilio C Campos, Full Professor of Ophthalmology, Head Ophthalmology Unit, University of Bologna, IRCCS Azienda Ospedaliero-Universitaria di Bologna

ClinicalTrials.gov Identifier:

NCT03064984

Other Study ID Numbers:

100/2016/O/Sper

First Posted:

Feb 27, 2017

Last Update Posted:

Feb 27, 2017

Last Verified:

Feb 1, 2017

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Sjogren's Syndrome

Graft vs Host Disease

Ophthalmic Solutions

Study Results

No Results Posted as of Feb 27, 2017