Allogenic Plasma Aliquots in the Treatment of Ligneous Conjunctivitis

Dorothy Bautista, MD

Status and phase: Invitation-only; Phase 3

Conditions: Ligneous Conjunctivitis, Left Eye

Treatments: Biological: Allogenic plasma aliquots, a source of plasminogen

Study type: Interventional

Funder types: Other

Identifiers

NCT04275232

DVB-LC-1

Details and patient eligibility

About

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.

Full 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

Enrollment: 1 estimated patient

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1 participants in 1 patient group

Allogenic Plasma Aliquots

Experimental group

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.

Treatment:

Biological: Allogenic plasma aliquots, a source of plasminogen