Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis
Primary Purpose
Ligneous Conjunctivitis, Left Eye
Status
Enrolling by invitation
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Allogenic plasma aliquots, a source of plasminogen
Sponsored by
About this trial
This is an interventional treatment trial for Ligneous Conjunctivitis, Left Eye
Eligibility Criteria
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
Sites / Locations
- Memorial University of Newfoundland
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Allogenic Plasma Aliquots
Arm Description
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.
Outcomes
Primary Outcome Measures
Resolution of pseudo membrane associated with ligneous conjunctivitis
Patient to be observed daily to every few weeks for resolution, based on clinical observation
Secondary Outcome Measures
Full Information
NCT ID
NCT04275232
First Posted
February 7, 2020
Last Updated
April 5, 2022
Sponsor
Dorothy Bautista, MD
Collaborators
Canadian Blood Services
1. Study Identification
Unique Protocol Identification Number
NCT04275232
Brief Title
Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis
Official Title
The Use of Allogenic Plasma Aliquots as a Source of Plasminogen in the Treatment of Ligneous Conjunctivitis, Clinical Trial of One Case
Study Type
Interventional
2. Study Status
Record Verification Date
April 2022
Overall Recruitment Status
Enrolling by invitation
Study Start Date
May 2023 (Anticipated)
Primary Completion Date
May 2023 (Anticipated)
Study Completion Date
May 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Dorothy Bautista, MD
Collaborators
Canadian Blood Services
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
Detailed 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ligneous Conjunctivitis, Left Eye
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Model Description
The patient will receive treatment with the interventional biologic product when she experiences recurrences of ligneous conjunctivitis
Masking
None (Open Label)
Allocation
N/A
Enrollment
1 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Allogenic Plasma Aliquots
Arm Type
Experimental
Arm Description
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.
Intervention Type
Biological
Intervention Name(s)
Allogenic plasma aliquots, a source of plasminogen
Intervention Description
Plasma eye drops, a source of plasminogen
Primary Outcome Measure Information:
Title
Resolution of pseudo membrane associated with ligneous conjunctivitis
Description
Patient to be observed daily to every few weeks for resolution, based on clinical observation
Time Frame
From date of first documented recurrence of pseudo membranes up to two years, starting from the date of enrolment
10. Eligibility
Sex
Female
Gender Based
Yes
Gender Eligibility Description
Clinical trial involves one patient (female)
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dorothy V Bautista, MD
Organizational Affiliation
Memorial University of Newfoundland
Official's Role
Principal Investigator
Facility Information:
Facility Name
Memorial University of Newfoundland
City
St. John's
State/Province
Newfoundland and Labrador
ZIP/Postal Code
A1B 3V6
Country
Canada
12. IPD Sharing Statement
Citations:
PubMed Identifier
28876531
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.
Results Reference
background
PubMed Identifier
23036559
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.
Results Reference
background
PubMed Identifier
21625933
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.
Results Reference
background
PubMed Identifier
27065432
Citation
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.
Results Reference
background
PubMed Identifier
29321155
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.
Results Reference
background
PubMed Identifier
27045067
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.
Results Reference
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Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis
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