Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis

NCT04275232 | Enrolling By Invitation Phase 3

• 1 other identifier: DVB-LC-1
• Study Type: interventional
• Target: 1
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Ligneous Conjunctivitis, Left Eye

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Allogenic Plasma Aliquots

EXPERIMENTAL

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.

Biological: Allogenic plasma aliquots, a source of plasminogen

Interventions

Allogenic plasma aliquots, a source of plasminogen BIOLOGICAL

Plasma eye drops, a source of plasminogen

Allogenic Plasma Aliquots

Eligibility Criteria

• Gender Eligibility Details: Clinical trial involves one patient (female)
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Subject has concurrent eye disease which prevents use of the investigational drug

Sponsors & Collaborators

• Dorothy Bautista, MD: lead
• Canadian Blood Services: collaborator

Study Sites (1)

Memorial University of Newfoundland

St. John's, Newfoundland and Labrador, A1B 3V6, Canada

Location

Related Publications (6)

• 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.

  PMID: 28876531 BACKGROUND

• 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.

  PMID: 23036559 BACKGROUND

• 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.

  PMID: 21625933 BACKGROUND

• 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.

  PMID: 27065432 BACKGROUND

• 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.

  PMID: 29321155 BACKGROUND

• 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.

  PMID: 27045067 BACKGROUND

MeSH Terms

Conditions

Plasminogen Deficiency, Type I

Study Officials

• Dorothy V Bautista, MD

  Memorial University of Newfoundland

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Clinical Professor

Model Details: The patient will receive treatment with the interventional biologic product when she experiences recurrences of ligneous conjunctivitis

Study Record Dates

• First Submitted: February 7, 2020
• First Posted: February 19, 2020
• Study Start: May 1, 2025
• Primary Completion: October 1, 2025
• Study Completion: October 1, 2025
• Last Updated: November 22, 2024

Record last verified: 2024-11

Locations

CA (1)