Safety and Efficacy Study of Corneal Collagen Cross-Linking in Eyes With Keratoconus

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2014 by Avedro, Inc.
Sponsor:
Information provided by (Responsible Party):
Avedro, Inc.
ClinicalTrials.gov Identifier:
NCT01643226
First received: July 16, 2012
Last updated: August 18, 2014
Last verified: August 2014
  Purpose

The objectives of this study are to evaluate the safety and efficacy of corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as compared to placebo in impeding the progression of, and/or reducing, maximum corneal curvature.


Condition Intervention Phase
Keratoconus
Drug: riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system
Drug: placebo: 0.0% riboflavin ophthalmic solution with the KXL system
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multi-Center, Randomized, Placebo-Controlled Evaluation of the Safety and Efficacy of the KXL System With VibeX (Riboflavin Ophthalmic Solution) for Corneal Collagen Cross-Linking in Eyes With Keratoconus

Resource links provided by NLM:


Further study details as provided by Avedro, Inc.:

Primary Outcome Measures:
  • Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group [ Time Frame: baseline to 6 months ] [ Designated as safety issue: No ]
  • Safety [ Time Frame: 12 months ] [ Designated as safety issue: Yes ]
    The primary safety endpoints are loss of BSCVA beginning at the 6 month follow-up examination, specifically, the percentage of eyes that have a loss of 15 or more letters in BSCVA on the ETDRS chart as compared to baseline and the incidence of serious ophthalmic adverse events.


Secondary Outcome Measures:
  • Mean change in maximum corneal curvature (Kmax) between the VibeX active treatment group and placebo control group [ Time Frame: baseline to 12 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 226
Study Start Date: July 2012
Estimated Study Completion Date: March 2016
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Riboflavin drops and UVA light exposure Drug: riboflavin: 0.12% riboflavin ophthalmic solution with the KXL system
Subjects will receive 0.12% riboflavin ophthalmic solution (VibeX) followed by irradiation with the KXL system at 30mW/cm^2 for 4 minutes
Placebo Comparator: Placebo and UVA light exposure Drug: placebo: 0.0% riboflavin ophthalmic solution with the KXL system
Subjects will receive 0.0% riboflavin ophthalmic solution (Placebo) followed by irradiation with the KXL system at 30mW/cm^2 for 4 minutes

Detailed Description:

The objectives of this study are to evaluate the safety and efficacy of corneal collagen cross-linking performed with VibeX (riboflavin ophthalmic solution) and the KXL System as compared to placebo in impeding the progression of, and/or reducing, maximum corneal curvature.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients must meet all of the following criteria in order to be enrolled into the trial:

  1. Be at least 12 years of age, male or female, of any race;
  2. Provide written informed consent and sign a HIPAA form. Patients who are under the age of 18 will need to sign an assent form as well as having a parent or legal guardian sign an informed consent;
  3. Willingness and ability to follow all instructions and comply with schedule for follow-up visits;
  4. For females capable of becoming pregnant, agree to have urine pregnancy testing performed prior to randomization of the study eye and prior to treatment of a fellow and/or cross-over eye; must not be lactating, and must agree to use a medically acceptable form of birth control for at least one week prior to the randomization visit, one week prior to treatment of a fellow eye or cross-over eye, and continue to use the method for one month following the last treatment. Acceptable forms for birth control are spermicide with barrier, oral contraceptive, injectable or implantable method of contraception, transdermal contraceptive, intrauterine device, or surgical sterilization of partner. For non-sexually active females, abstinence will be considered an acceptable form of birth control. Women considered capable of becoming pregnant include all females who have experienced menarche and have not experienced menopause (as defined by amenorrhea for greater than 12 consecutive months) or have not undergone successful surgical sterilization (e.g. hysterectomy, bilateral tubal ligation, or bilateral oophorectomy);
  5. Having topographic evidence of keratoconus with a diagnosis of mild, moderate, or severe keratoconus defined as the following:

    • Mild Keratoconus:

      • Axial topography consistent with keratoconus
      • Flat Pentacam keratometry reading ≤ 51.00D
    • Moderate Keratoconus:

      • Axial topography consistent with keratoconus
      • Flat Pentacam keratometry reading ≥ 51.01 D and ≤ 56.00 D or astigmatism ≥ 8.00 D
    • Severe Keratoconus:

      • Axial topography consistent with keratoconus with marked areas of steepening
      • Flat Pentacam keratometry reading ≥ 56.01 D
  6. Presence of central or inferior steepening on the Pentacam map;
  7. Have a maximum corneal curvature, as measured by Kmax of ≥ 47.00 D;
  8. BSCVA (Best Spectacle Corrected Visual Acuity) of ≥ 1 letter and ≤ 80 letters on ETDRS (Early Treatment of Diabetic Retinopathy Study) chart;
  9. Contact Lens Wearers Only: Removal of contact lenses is required for a 1 week period prior to the screening visit(s);
  10. Contact Lens Wearers Only: Manifest refraction must be stable between two visits which occur at least 7 days apart. A stable refraction is one in which the manifest refraction spherical equivalent and the average K (Km) on the Pentacam taken at the first visit do not differ by more than 0.75 D from the respective measurements taken at the second exam.

Exclusion Criteria:

Patients must not meet any of the following criteria in order to be enrolled in the trial:

  1. Contraindications, sensitivity or known allergy to the use of the test article(s) or their components;
  2. If female, be pregnant, nursing or planning a pregnancy or have a positive urine pregnancy test prior to the randomization or treatment of either eye or during the course of the study;
  3. Eyes classified as either normal, atypical normal, or keratoconus suspect on the severity grading scheme;
  4. A history of previous corneal surgery or the insertion of Intacs in the eye to be treated;
  5. A history of previous Limbal Relaxing Incision (LRI) procedure in the eye to be treated;
  6. Corneal pachymetry that is < 375 microns prior to epithelial debridement at the thinnest point measured by Pentacam in the eye to be treated;
  7. Eyes which are aphakic;
  8. Eyes which are pseudophakic and do not have a UV blocking lens implanted;
  9. Eyes that have the maximum corneal curvature (Kmax) outside of the central 5mm zone as measured by the Pentacam;
  10. Previous ocular condition (other than refractive error) in the eye to be treated that may predispose the eye for future complications. For example:

    1. History of corneal disease (e.g., herpes simplex, herpes zoster keratitis, corneal melt, corneal dystrophy, etc.);
    2. Clinically significant corneal scarring in the cross-linking treatment zone that is not related to keratoconus or, in the investigator's opinion, will interfere with the cross-linking procedure;
  11. A history of delayed epithelial healing in the eye to be treated;
  12. Patients with nystagmus or any other condition that would prevent a steady gaze during the treatment or other diagnostic tests;
  13. Patients with a current condition that, in the investigator's opinion, would interfere with or prolong epithelial healing;
  14. Taking Vitamin C (ascorbic acid) supplements within 1 week of the cross-linking treatment.
  15. A history of previous corneal crosslinking treatment in the eye to be treated;
  16. Have used an investigational drug or device within 30 days of the study or be concurrently enrolled in another investigational drug or device trial within 30 days of the study;
  17. In addition, the Investigator may exclude or discontinue any subject for any sound medical reason.
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01643226

Locations
United States, California
Gordon -Weiss Vision Institute Recruiting
San Diego, California, United States, 92122
Contact: Elizabeth Medina    858-455-9972 ext 153    emedina@gwsvision.com   
Contact: Dorothy Wang    858-455-9972 ext 153    dwang@gordonweissvision.com   
Principal Investigator: Michael Gordon, MD         
United States, Indiana
Price Vision Group Recruiting
Indianapolis, Indiana, United States, 46260
Contact: Tiffany Schendel    317-814-2995    tiffanyschendel@pricevisiongroup.net   
Principal Investigator: Francis Price, MD         
United States, Kansas
Durrie Vision Recruiting
Overland Park, Kansas, United States, 66211
Contact: Teresa Nolan    913-234-4119 ext 7214    tnolan@durrievision.com   
Principal Investigator: Daniel Durrie, MD         
United States, New Jersey
Cornea & Laser Eye Institute; Hersh Vision Group Recruiting
Teaneck, New Jersey, United States, 07666
Contact: BethAnn Furlong--Hibbert    201-883-0505    Bfurlong-hibbert@vision-institute.com   
Contact: Stacy Lazar    201-883-0505    slazar@vision-institute.com   
Principal Investigator: Peter Hersh, MD         
United States, New York
Columbia University Harkness Eye Institute Not yet recruiting
New York, New York, United States, 10032
Contact: Edylin Bautista    212-305-5922    mmb2225@columbia.edu   
Principal Investigator: Leejee Suh, MD         
United States, Pennsylvania
UPMC Eye Center Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Stefanie Mader    412-647-7603    madersk@upmc.edu   
Contact: Kristy Truman    412-383-8778    trumank@upmc.edu   
Principal Investigator: Deepinder Dhaliwal, MD         
United States, Virginia
See Clearly Vision Recruiting
McLean, Virginia, United States, 22102
Contact: Josef Tamory    703-827-5454 ext 4029    jtamory@seeclearly.com   
Principal Investigator: Rajesh Rajpal, MD         
Sponsors and Collaborators
Avedro, Inc.
Investigators
Study Director: Gerry Lohan Avedro, Inc.
  More Information

No publications provided

Responsible Party: Avedro, Inc.
ClinicalTrials.gov Identifier: NCT01643226     History of Changes
Other Study ID Numbers: KXL-002
Study First Received: July 16, 2012
Last Updated: August 18, 2014
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Keratoconus
Corneal Diseases
Eye Diseases
Ophthalmic Solutions
Riboflavin
Pharmaceutical Solutions
Therapeutic Uses
Pharmacologic Actions
Vitamin B Complex
Vitamins
Micronutrients
Growth Substances
Physiological Effects of Drugs
Photosensitizing Agents
Dermatologic Agents
Radiation-Sensitizing Agents

ClinicalTrials.gov processed this record on August 25, 2014