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

NCT03064984 | Unknown DMC

• 1 other identifier: 100/2016/O/Sper
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 3

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.

Conditions

Keratopathy; Sjogren's Syndrome; GVHD - Graft-Versus-Host Disease

Outcome Measures

Primary Outcomes (1)

• Variation of corneal epithelium damage

  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

  30 days

Secondary Outcomes (1)

• Variation of subjective sensation of discomfort

  30 days

Study Arms (2)

CBS eyedrops

ACTIVE COMPARATOR

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

ACTIVE COMPARATOR

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

Interventions

CBS eyedrops OTHER

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.

PBS eyedrops

PBS eyedrops OTHER

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.

CBS eyedrops

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• IRCCS Azienda Ospedaliero-Universitaria di Bologna: lead
• University of Bologna: collaborator
• Regione Emilia-Romagna: collaborator
• Centro Nazionale Sangue: collaborator

Study Sites (3)

AOU Bologna, Ophthalmology Unit

Bologna, Bologna, 40138, Italy

RECRUITING

Ospedale S.Maria Nuova - IRCCS - Ophthalmology Unit

Reggio Emilia, Reggio Emilia, 42123, Italy

NOT YET RECRUITING

Ospedale degli Infermi, Ophtalmology Unit

Rimini, Rimini, 47900, Italy

NOT YET RECRUITING

Related Publications (17)

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• Yoon KC, Im SK, Park YG, Jung YD, Yang SY, Choi J. Application of umbilical cord serum eyedrops for the treatment of dry eye syndrome. Cornea. 2006 Apr;25(3):268-72. doi: 10.1097/01.ico.0000183484.85636.b6.

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• Yoon KC, You IC, Im SK, Jeong TS, Park YG, Choi J. Application of umbilical cord serum eyedrops for the treatment of neurotrophic keratitis. Ophthalmology. 2007 Sep;114(9):1637-42. doi: 10.1016/j.ophtha.2006.12.014. Epub 2007 Mar 26.

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• Versura P, Profazio V, Buzzi M, Stancari A, Arpinati M, Malavolta N, Campos EC. Efficacy of standardized and quality-controlled cord blood serum eye drop therapy in the healing of severe corneal epithelial damage in dry eye. Cornea. 2013 Apr;32(4):412-8. doi: 10.1097/ICO.0b013e3182580762.

  PMID: 22955120 BACKGROUND

• Versura P, Buzzi M, Giannaccare G, Grillini M, Terzi A, Pagliaro P, Campos EC. Cord blood serum-based eye drops: the impact of donor haematological and obstetric factors on the variability of epidermal growth factor levels. Blood Transfus. 2014 Jan;12 Suppl 1(Suppl 1):s44-50. doi: 10.2450/2013.0115-13. Epub 2013 Oct 3.

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• Versura P, Buzzi M, Giannaccare G, Terzi A, Fresina M, Velati C, Campos EC. Targeting growth factor supply in keratopathy treatment: comparison between maternal peripheral blood and cord blood as sources for the preparation of topical eye drops. Blood Transfus. 2016 Mar;14(2):145-51. doi: 10.2450/2015.0020-15. Epub 2015 Jul 9.

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• Campos E, Versura P, Buzzi M, Fontana L, Giannaccare G, Pellegrini M, Lanconelli N, Brancaleoni A, Moscardelli F, Sebastiani S, Vaselli C, Randi V. Blood derived treatment from two allogeneic sources for severe dry eye associated to keratopathy: a multicentre randomised cross over clinical trial. Br J Ophthalmol. 2020 Aug;104(8):1142-1147. doi: 10.1136/bjophthalmol-2019-314859. Epub 2019 Nov 19.

  PMID: 31744796 DERIVED

MeSH Terms

Conditions

Sjogren's Syndrome; Graft vs Host Disease

Condition Hierarchy (Ancestors)

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; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Emilio C Campos, MD

  AOU Bologna, University of Bologna

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Emilio C Campos, MD

CONTACT

+39 051 2142831; emilio.campos@unibo.it

Piera Versura, BSD

CONTACT

+39 051 2142850; piera.versura@unibo.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Full Professor of Ophthalmology, Head Ophthalmology Unit, University of Bologna

Model Details: 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.

Study Record Dates

• First Submitted: February 15, 2017
• First Posted: February 27, 2017
• Study Start: January 30, 2017
• Primary Completion: June 30, 2017
• Study Completion: September 30, 2017
• Last Updated: February 27, 2017

Record last verified: 2017-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (3)