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

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ClinicalTrials.gov Identifier: NCT03064984
Recruitment Status : Unknown
Verified February 2017 by Emilio C Campos, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi.
Recruitment status was:  Recruiting
First Posted : February 27, 2017
Last Update Posted : February 27, 2017
Sponsor:
Collaborators:
University of Bologna
Regione Emilia-Romagna
Centro Nazionale Sangue
Information provided by (Responsible Party):
Emilio C Campos, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi

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 Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated 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.

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 : January 30, 2017
Estimated Primary Completion Date : June 30, 2017
Estimated Study Completion Date : September 30, 2017

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Variation of corneal epithelium damage [ Time Frame: 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 :
  1. Variation of subjective sensation of discomfort [ Time Frame: 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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 .

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03064984


Contacts
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Contact: Emilio C Campos, MD +39 051 2142831 emilio.campos@unibo.it
Contact: Piera Versura, BSD +39 051 2142850 piera.versura@unibo.it

Locations
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Italy
AOU Bologna, Ophthalmology Unit Recruiting
Bologna, Italy, 40138
Contact: Emilio C Campos, MD    + 390512142831    emilio.campos@unibo.it   
Contact: Piera Versura, BSD    + 390512142850    piera.versura@unibo.it   
Sub-Investigator: Giuseppe Giannaccare, PhD         
Ospedale S.Maria Nuova - IRCCS - Ophthalmology Unit Not yet recruiting
Reggio Emilia, Italy, 42123
Contact: Luigi Fontana, MD, PHD    +393382060005    luigi.fontana@asmn.re.it   
Ospedale degli Infermi, Ophtalmology Unit Not yet recruiting
Rimini, Italy, 47900
Contact: Alessandra Brancaleoni, MD    +390541608692    alebranca@me.com   
Contact: Stefano Volanti, MD    +390541608692    stefanovolanti@libero.it   
Sponsors and Collaborators
Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
University of Bologna
Regione Emilia-Romagna
Centro Nazionale Sangue
Investigators
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Principal Investigator: Emilio C Campos, MD AOU Bologna, University of Bologna

Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Emilio C Campos, Full Professor of Ophthalmology, Head Ophthalmology Unit, University of Bologna, Azienda Ospedaliera Universitaria di Bologna Policlinico S. Orsola Malpighi
ClinicalTrials.gov Identifier: NCT03064984     History of Changes
Other Study ID Numbers: 100/2016/O/Sper
First Posted: February 27, 2017    Key Record Dates
Last Update Posted: February 27, 2017
Last Verified: February 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sjogren's Syndrome
Graft vs Host Disease
Immune System Diseases
Arthritis, Rheumatoid
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases
Dry Eye Syndromes
Lacrimal Apparatus Diseases
Eye Diseases
Connective Tissue Diseases
Autoimmune Diseases
Ophthalmic Solutions
Pharmaceutical Solutions