Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis

NCT ID: NCT04275232

Last Updated: 2024-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ENROLLING_BY_INVITATION

Clinical Phase

PHASE3

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-31

Study Completion Date

2025-10-31

Brief Summary

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Allogenic plasma aliquots, used as eye drops, will provide a source of plasminogen in the treatment of ligneous conjunctivitis. The investigational product will be available through written request from the Sponsor-Investigator to Canadian Blood Services, as approved by Health Canada.

Detailed Description

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Ligneous conjunctivitis is a chronic progressive disorder of the conjunctival mucosa which occurs secondary to plasminogen deficiency. The condition is characterized by thick, fibrous pseudo membranes adherent to the conjunctival surface of the eye lid.The investigational product, allogenic plasma aliquots, is a source of plasminogen. It will be used as eye drops, to treat recurrences of these pseudo membranes by providing the plasminogen required for fibrinolysis. The allogenic plasma aliquots are prepared by Canadian Blood Services. An initial supply of 680 vials was made available through the Special Access program, upon approval by Health Canada. Through this Clinical Trial, additional allogenic plasma aliquots will be available when required to treat recurrences of the pseudo membranes. The study has been conditionally approved by local HREB, pending registration with clinicaltrials.gov

Conditions

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Ligneous Conjunctivitis, Left Eye

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

The patient will receive treatment with the interventional biologic product when she experiences recurrences of ligneous conjunctivitis
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Allogenic Plasma Aliquots

Allogenic Plasma Aliquots to be used as eye drops in the treatment of recurrences of ligneous conjunctivitis. Two drops will be administered to the affected eye, every 1 to 4 hours, depending on severity of the recurrence.

Group Type EXPERIMENTAL

Allogenic plasma aliquots, a source of plasminogen

Intervention Type BIOLOGICAL

Plasma eye drops, a source of plasminogen

Interventions

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Allogenic plasma aliquots, a source of plasminogen

Plasma eye drops, a source of plasminogen

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Subject diagnosed with ligneous conjunctivitis associated with Type 1 plasminogen deficiency

Exclusion Criteria

* Subject has concurrent eye disease which prevents use of the investigational drug
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Canadian Blood Services

OTHER

Sponsor Role collaborator

Dorothy Bautista, MD

OTHER

Sponsor Role lead

Responsible Party

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Dorothy Bautista, MD

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Dorothy V Bautista, MD

Role: PRINCIPAL_INVESTIGATOR

Memorial University of Newfoundland

Locations

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Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, Canada

Site Status

Countries

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Canada

References

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Kizilocak H, Ozdemir N, Dikme G, Koc B, Atabek AA, Cokugras H, Iskeleli G, Donmez-Demir B, Christiansen NM, Ziegler M, Ozdag H, Schuster V, Celkan T. Treatment of plasminogen deficiency patients with fresh frozen plasma. Pediatr Blood Cancer. 2018 Feb;65(2). doi: 10.1002/pbc.26779. Epub 2017 Sep 6.

Reference Type BACKGROUND
PMID: 28876531 (View on PubMed)

Ku JY, Lichtinger A, Yeung SN, Kim P, Cserti-Gazdewich C, Slomovic AR. Topical fresh frozen plasma and heparin treatment of ligneous conjunctivitis in a Canadian hospital setting. Can J Ophthalmol. 2012 Oct;47(5):e27-8. doi: 10.1016/j.jcjo.2012.03.025. Epub 2012 Jul 13. No abstract available.

Reference Type BACKGROUND
PMID: 23036559 (View on PubMed)

Pergantou H, Likaki D, Fotopoulou M, Katsarou O, Xafaki P, Platokouki H. Management of ligneous conjunctivitis in a child with plasminogen deficiency. Eur J Pediatr. 2011 Oct;170(10):1333-6. doi: 10.1007/s00431-011-1483-9. Epub 2011 May 31.

Reference Type BACKGROUND
PMID: 21625933 (View on PubMed)

Ang MJ, Papageorgiou KI, Chang SH, Kohn J, Chokron Garneau H, Goldberg RA. Topical Plasminogen as Adjunctive Treatment in Recurrent Ligneous Conjunctivitis. Ophthalmic Plast Reconstr Surg. 2017 Mar/Apr;33(2):e37-e39. doi: 10.1097/IOP.0000000000000694.

Reference Type BACKGROUND
PMID: 27065432 (View on PubMed)

Shapiro AD, Nakar C, Parker JM, Albert GR, Moran JE, Thibaudeau K, Thukral N, Hardesty BM, Laurin P, Sandset PM. Plasminogen replacement therapy for the treatment of children and adults with congenital plasminogen deficiency. Blood. 2018 Mar 22;131(12):1301-1310. doi: 10.1182/blood-2017-09-806729. Epub 2018 Jan 10.

Reference Type BACKGROUND
PMID: 29321155 (View on PubMed)

Conforti FM, Di Felice G, Bernaschi P, Bartuli A, Bianco G, Simonetti A, Buzzonetti L, Valente P, Corsetti T. Novel plasminogen and hyaluronate sodium eye drop formulation for a patient with ligneous conjunctivitis. Am J Health Syst Pharm. 2016 Apr 15;73(8):556-61. doi: 10.2146/ajhp150395.

Reference Type BACKGROUND
PMID: 27045067 (View on PubMed)

Other Identifiers

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DVB-LC-1

Identifier Type: -

Identifier Source: org_study_id

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