Clinical trial NCT02863809: Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Keratolysis
Keywords: Keratolysis
Corneal Melting
Boston KPro
Keratoprosthesis
Lead sponsor: Massachusetts Eye and Ear Infirmary
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2016-08-11
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Time From Surgery to Device Loss or Replacement
timeFrame: 2 years
Secondary outcomes:
measure: Number of Participants With Kpro Retention at 12 Months
timeFrame: Twelve months
measure: Number of Cumulative Delayed Epithelial Healing Events at Day 30
timeFrame: 30 days
measure: Median Time From Surgery to Retroprosthetic Membrane Treatment in Days (Laser or Surgical Interventions)
timeFrame: 2 years
measure: Median Time From Surgery to Occurrence of Vitritis (Sterile or Infectious)
timeFrame: 2 years
Other outcomes:
Locations:
city: Los Angeles
country: United States
facility: The Jules Stein Eye Institute
state: California
city: Sacramento
country: United States
facility: UC Davis Health System Eye Center
state: California
city: San Diego
country: United States
facility: Shiley Eye Institute, University of California, San Diego
state: California
city: Miami
country: United States
facility: Bascom Palmer eye Institute
state: Florida
city: Chicago
country: United States
facility: Illinois Eye and Ear Infirmary
state: Illinois
city: Edgewood
country: United States
facility: Cincinnati Eye Institute
state: Kentucky
city: Baltimore
country: United States
facility: Wilmer Eye Institute
state: Maryland
city: Ann Arbor
country: United States
facility: W.K. Kellogg Eye Center
state: Michigan
city: Kansas City
country: United States
facility: Tauber Eye Center
state: Missouri
city: New York
country: United States
facility: David and Ilene Flaum Eye Institute, University of Rochester
state: New York
city: Cleveland
country: United States
facility: University Hospitals Eye Institute
state: Ohio
city: Bala-Cynwyd
country: United States
facility: Wills Eye
state: Pennsylvania
city: Lackland Air Force Base
country: United States
facility: Wilford Hall Ambulatory Surgical Center (WHASC)
state: Texas
Study officials:
affiliation: Massachusetts Eye and Ear Infirmary
name: Joseph B. Ciolino, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Davis SA, Bovelle R, Han G, Kwagyan J. Corneal collagen cross-linking for bacterial infectious keratitis. Cochrane Database Syst Rev. 2020 Jun 17;6(6):CD013001. doi: 10.1002/14651858.CD013001.pub2.