Sponsor Initiated Expanded Access Protocol, Intermediate-Size Patient Population

This is an expanded access trial for Ligneous Conjunctivitis Read More

Inclusion Criteria:

• Subjects diagnosed with LC associated with Type I plasminogen deficiency, confirmed by laboratory documentation at screening visit, with or without ocular pseudomembranes. The presence of membranes in different areas is not an exclusion criterion.
• Subjects and their legally authorized representative, in the case of subjects <18 years of age, should be informed of the nature of the treatment, agree to its provision, sign and date the informed and data handling consent forms approved by the IRB.
• Subjects must be available for the duration of the treatment and agree to be compliant with the protocol visit and follow-up schedule.
• Subjects agree to keep the treating physician or specialist in charge informed about any occurrence related to the treatment.

Exclusion Criteria:

• Subjects with any condition which, in the opinion of the treating physician or specialist in charge might interfere with the treatment.
• Females of childbearing potential who are either pregnant or not using an adequate method of birth control (adequate is defined as hormonal contraceptive or partner vasectomy for at least 3 months, condoms, intrauterine device [IUD], abstinence or other prescribed birth control). Enrolled males must agree to utilize appropriate contraceptive methods to prevent pregnancy in partners.
• Females who are breastfeeding.