Working…
COVID-19 is an emerging, rapidly evolving situation.
Get the latest public health information from CDC: https://www.coronavirus.gov.

Get the latest research information from NIH: https://www.nih.gov/coronavirus.
ClinicalTrials.gov
ClinicalTrials.gov Menu

Vision Restoration With a Collagen Crosslinked Boston Keratoprosthesis Unit

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02863809
Recruitment Status : Active, not recruiting
First Posted : August 11, 2016
Last Update Posted : September 25, 2020
Sponsor:
Collaborator:
United States Department of Defense
Information provided by (Responsible Party):
Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary

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.

Condition or disease Intervention/treatment Phase
Keratolysis Drug: Riboflavin Drug: Dextran Device: UVA Light Source Phase 1 Phase 2

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 69 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
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
Actual Study Start Date : March 15, 2017
Estimated Primary Completion Date : June 2021
Estimated Study Completion Date : August 2021


Arm Intervention/treatment
Experimental: Active Treatment Arm
De-epithelialized corneas cross-linked with riboflavin 0.1% and dextran 20% solution AND ultraviolet A light (UVA Light Source).
Drug: Riboflavin
Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Other Name: Vitamin B2

Drug: Dextran
Dextran is used to increase the viscosity of the solution.
Other Names:
  • Dextran 70 6% in 0.9%
  • Sodium Chloride Dextran 70 6% in 5% Dextrose
  • Gentran 70, Hyskon

Device: UVA Light Source
Avedro's KXL® System is a UVA irradiation system that uses a light emitting diode (LED) to deliver a dose of UVA light to a targeted treatment area for illuminating the cornea during corneal collagen cross-linking.
Other Name: KXL® System

Active Comparator: Control Treatment Arm
De-epithelialized corneas will be exposed to only riboflavin 0.1% with dextran 20% solution (NO ultraviolet A light).
Drug: Riboflavin
Riboflavin, a water soluble vitamin, is an essential nutrient and a natural component of many foods.
Other Name: Vitamin B2

Drug: Dextran
Dextran is used to increase the viscosity of the solution.
Other Names:
  • Dextran 70 6% in 0.9%
  • Sodium Chloride Dextran 70 6% in 5% Dextrose
  • Gentran 70, Hyskon




Primary Outcome Measures :
  1. Time from surgery to device loss or replacement [ Time Frame: 2 years ]
    If the device fails after surgery the time and reason behind the failure will be recorded. The number of device losses in the control group will be compared to the number of device losses in investigational group.


Secondary Outcome Measures :
  1. Twelve-month retention rate [ Time Frame: Twelve months ]
    The number of retained devices at the end of twelve months will be studied and differences in retention rate between investigational and control groups will be reported

  2. Incidence of delayed epithelial healing at day 7 [ Time Frame: 7 days ]
    The incidences of delayed epithelial healing at day 7 will be recorded. If there is delayed epithelial healing at day 7 it will be determined if those incidences occurred more often in the control group versus the investigational group.

  3. Cornea thickness metrics measured by AS-OCT; at week(s) 1, 4, 16, 24, 36, 52, 78, and 104. [ Time Frame: week(s) 1, 4, 16, 24, 36, 52, 78, and 104 ]
    Cornea thickness will be measured before and after study intervention and at all follow up visits. Corneal thickness will be analyzed and occurrences will be recorded to compare between study groups.

  4. Time from surgery to retroprosthetic membrane treatment (laser or surgical interventions) [ Time Frame: 2 years ]
    If follow up surgery is needed to replace or treat the prosthetic the time and reason will be recorded and these incidences will be compared between the study treatment groups

  5. Time from surgery to occurrence of vitritis (sterile or infectious) [ Time Frame: 2 years ]
    The incidences of vitritis will be recorded and the number of incidences will be compared between the study treatment groups. The timing of these incidences will also be recorded.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02863809


Locations
Layout table for location information
United States, California
The Jules Stein Eye Institute
Los Angeles, California, United States, 90095-7003
UC Davis Health System Eye Center
Sacramento, California, United States, 95817
Shiley Eye Institute, University of California, San Diego
San Diego, California, United States, 92093
United States, Florida
Bascom Palmer eye Institute
Miami, Florida, United States, 33136
United States, Illinois
Illinois Eye and Ear Infirmary
Chicago, Illinois, United States, 60612
United States, Kentucky
Cincinnati Eye Institute
Edgewood, Kentucky, United States, 41017
United States, Maryland
Wilmer Eye Institute
Baltimore, Maryland, United States, 21287
United States, Michigan
W.K. Kellogg Eye Center
Ann Arbor, Michigan, United States, 48105
United States, Missouri
Tauber Eye Center
Kansas City, Missouri, United States, 64111
United States, New York
David and Ilene Flaum Eye Institute, University of Rochester
New York, New York, United States, 14642
United States, Ohio
University Hospitals Eye Institute
Cleveland, Ohio, United States, 44106
United States, Pennsylvania
Wills Eye
Bala-Cynwyd, Pennsylvania, United States, 19007
United States, Texas
Wilford Hall Ambulatory Surgical Center (WHASC)
Lackland Air Force Base, Texas, United States, 78236
Sponsors and Collaborators
Joseph B. Ciolino, MD
United States Department of Defense
Investigators
Layout table for investigator information
Principal Investigator: Joseph B. Ciolino, MD Massachusetts Eye and Ear Infirmary
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Joseph B. Ciolino, MD, Professor of Opthalmology, Massachusetts Eye and Ear Infirmary
ClinicalTrials.gov Identifier: NCT02863809    
Other Study ID Numbers: 798474
First Posted: August 11, 2016    Key Record Dates
Last Update Posted: September 25, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: The data within StudyTrax will be extracted at the completion of the study. This data will be held in a secure network file at MEEI for at least two years following a marketing application submission to the FDA or longer, if required by the MEEI IRB.

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: Yes
Keywords provided by Joseph B. Ciolino, MD, Massachusetts Eye and Ear Infirmary:
Keratolysis
Corneal Melting
Boston KPro
Keratoprosthesis
Additional relevant MeSH terms:
Layout table for MeSH terms
Riboflavin
Dextrans
Vitamins
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Vitamin B Complex
Photosensitizing Agents
Dermatologic Agents
Anticoagulants
Plasma Substitutes
Blood Substitutes