Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

A Phase I/II Prospective, Randomized, Multicenter, Double-Masked, Vehicle-Controlled Clinical Trial to Evaluate the Safety and Efficacy of Corneal Collagen Cross-Linking of Keratoprosthesis Carrier Tissue in High-Risk Keratoprosthesis Implantation

This is a phase I/II prospective, randomized, multi-center, double-masked, vehicle-controlled clinical trial evaluating the safety and efficacy of corneal collagen cross-linking the keratoprosthesis carrier tissue in subjects who are candidates for high-risk keratoprosthesis implantation but because of a history of corneal melts or autoimmune diseases are not candidate for a traditional corneal transplant.

The study is a multi-center, parallel, randomized, double-blinded study with subsequent follow-up period of two years. Eight-four subjects across twelve sites will be randomized 1:1 to receive either a corneal tissue that have been cross-linked or not cross-linked (No UVA light source). Cross-linking is a term that refers to the linking of polymers (long chain) molecules by chemical bonds. It is believed that cross-linking the cornea will make the cornea stronger and more resistant to degradation.

CorneaGen (formerly Keralink International) (Baltimore site) will supply the donor tissue and Avedro Inc (Waltham MA) will supply the riboflavin and the UV light source. Staff at CorneaGenwill administer the riboflavin with dextran solution and perform the cross-linking procedure according to one of randomization groups before shipping the masked donor cornea to study sites for Boston Keratoprosthesis (B-KPro) implantation.

Inclusion Criteria:

• Willing and able to provide written informed consent

• Willing and able to comply with study assessments for the full duration of the study

• Age ≥ 18 years

• Candidate for a Boston Keratoprosthesis / Cornea transplant

• In generally good stable overall health

• Patients with an eye at risk for a cornea sterile ulcer which includes:

  • Autoimmune diseases (mucus membrane pemphigoid, Stevens-Johnson syndrome, systemic lupus erythematosis, rheumatoid arthritis, or other autoimmune diseases); OR
  • History of previous sterile cornea ulceration requiring a cornea transplant

Exclusion Criteria:

• Age < 18 years
• Inability to provide written informed consent and comply with study assessments for the full duration of the study
• No or minimal tear production with evidence of keratinization of the bulbar conjunctiva
• Corneal or ocular surface infection within 30 days prior to study entry
• Ocular or periocular malignancy
• Inability to wear a contact lens due to lid abnormalities or shortened fornix
• Signs of current infection, including fever and current treatment with antibiotics
• Pregnancy (positive pregnancy test) or lactating
• Participation in another simultaneous interventional medical investigation or trial