Ligneous Conjunctivitis, Left Eye Clinical Trial
Official title:
The Use of Allogenic Plasma Aliquots as a Source of Plasminogen in the Treatment of Ligneous Conjunctivitis, Clinical Trial of One Case
| Verified date | April 2023 |
| Source | Memorial University of Newfoundland |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| 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 |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Memorial University of Newfoundland | St. John's | Newfoundland and Labrador |
| Lead Sponsor | Collaborator |
|---|---|
| Dorothy Bautista, MD | Canadian Blood Services |
Canada,
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
| 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 |