Clinical Trial of Gene Therapy for Leber Congenital Amaurosis Caused by RPE65 Mutations

Exclusion Criteria

• •Immune deficiency or use of immunosuppressive medications;
• •Pre-existing eye conditions that would preclude the planned surgery or interfere with the interpretation of study endpoints (for example, glaucoma or ocular media opacities);
• •Complicating systemic diseases;
• •Impaired coagulation or use of anti-platelet agents within 7 days prior to study agent administration;
• •Pregnancy or breastfeeding;
• •Individuals (males and females) of childbearing potential who are unwilling to use effective contraception for 1 year following agent administration and barrier contraception for 3 months following agent administration;
• •Any other condition that would prevent a subject from completing follow-up examinations during the course of the study;
• •Any other condition that, in the opinion of the investigator, makes the subject unsuitable for the study;
• •Current or recent participation in any other research protocol involving investigational agents or therapies, including recent (within past 6 months) receipt of an investigational biologic therapeutic agent.
• •Subjects will not be excluded based on their gender, race or ethnicity.