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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT04275232
Other study ID # DVB-LC-1
Secondary ID
Status Enrolling by invitation
Phase Phase 3
First received
Last updated
Start date May 2024
Est. completion date May 2024

Study information

Verified date April 2023
Source Memorial University of Newfoundland
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 1
Est. completion date May 2024
Est. primary completion date May 2024
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group N/A and older
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Biological:
Allogenic plasma aliquots, a source of plasminogen
Plasma eye drops, a source of plasminogen

Locations

Country Name City State
Canada Memorial University of Newfoundland St. John's Newfoundland and Labrador

Sponsors (2)

Lead Sponsor Collaborator
Dorothy Bautista, MD Canadian Blood Services

Country where clinical trial is conducted

Canada, 

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Resolution of pseudo membrane associated with ligneous conjunctivitis Patient to be observed daily to every few weeks for resolution, based on clinical observation From date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment