Management of Recurrent and Progressive Ligneous Conjunctivitis Due to Plasminogen Deficiency. An N of One Clinical Trial of Topical Administration of Allogenic Plasma to Affected Eye

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

Congenital plasminogen deficiency causes impaired wound healing and growth of pseudomembranous lesions over multiple parts of the body. The most common lesions involve eyes and are known as Ligneous conjunctivitis. These can cause scarring of the sclera, vision loss and even blindness. These pseudomembranous lesions are recur after surgical excisions, administration of intra-ocular cyclosporine, autologous serum drops or corticosteroids. Clinical data shows that these growths do not worsen and do not recur after administration of plasminogen (either as concentrate or as plasma) in the eyes, locally or intravenously. As plasminogen is not available as concentrate, we are using aliquoted allogenic plasma provided by Canadian Blood Services for intra-ocular application. These will be applied to eyes multiple times a day for a period of 2 to 6 months depending on disease severity and patient response. These may be used again if ligneous conjunctivitis recurs. The patient will be followed for a period of 2 years at least. All serious adverse events will be reported to Canadian Blood Services and Health Canada as appropriate.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 1 month
Maximum Age: 18
Healthy Volunteers: f
View:

• Patients under the age of 18 years

• Diagnosis of plasminogen deficiency (Definition: clinical presence of pseudomembranous lesions and serum plasminogen level \< 50%)

• Ocular involvement (Ligneous Conjunctivitis) due to plasminogen deficiency

Locations
Other Locations
Canada
University of Saskatchewan
RECRUITING
Saskatoon
Contact Information
Primary
Sarah Tehseen, MBBS MSc.
sarah.tehseen@saskhealthauthority.ca
639-998-3972
Backup
Simona Meier, BSc, ACRP-CP.
simona.meier@usask.ca
306-978-8302
Time Frame
Start Date: 2022-12-15
Estimated Completion Date: 2024-12-31
Participants
Target number of participants: 1
Treatments
Experimental: Intervention arm (aliquoted plasma application into the conjunctiva)
This is the only arm of the study. The intervention is administration of aliquoted plasma provided by Canadian Blood Services in eye droppers (3 ml aliquots in 7 ml vials) in the patient's conjunctiva.~The duration of therapy can be 2 to 6 months depending on response The intra-ocular drops will be administered every 1-5 hours daily in the affected eye based on disease severity and may be repeated
Sponsors
Collaborators: Canadian Blood Services
Leads: University of Saskatchewan

This content was sourced from clinicaltrials.gov

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