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

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2014 by Avedro, Inc.
Sponsor:
Information provided by (Responsible Party):
Avedro, Inc.
ClinicalTrials.gov Identifier:
NCT01344187
First received: April 27, 2011
Last updated: July 16, 2014
Last verified: July 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
Experimental: 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 he following criteria in order to be enrolled into 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: NCT01344187

Locations
United States, California
UC Irvine Department of Ophthalmology Recruiting
Irvine, California, United States, 92697
Contact: Jeff Grijalva    714-456-7741    jgrijalv@uci.edu   
Principal Investigator: Sam Garg, MD         
United States, Florida
Bascolm Palmer Eye Institute Recruiting
Miami, Florida, United States, 33136
Contact: Ruth Vandenbroucke    305-482-4739    rvandenbroucke@med.miami.edu   
Principal Investigator: Sonia Yoo, MD         
United States, Georgia
Emory Eye Center Recruiting
Atlanta, Georgia, United States, 30342
Contact: Jeff Horton    404-778-4425    jeff.horton@emory.edu   
Principal Investigator: J. Bradley Randleman, MD         
United States, Massachusetts
Ophthalmic Consultants of Boston Active, not recruiting
Waltham, Massachusetts, United States, 02451
United States, Nebraska
Kugler Vision Not yet recruiting
Omaha, Nebraska, United States, 68144
Contact: Linda Morgan, OD    402-588-2211    drmorgan@lasikomaha.com   
Principal Investigator: Lance Kugler, MD         
United States, New Jersey
Pinceton Eye Goup Recruiting
Princeton, New Jersey, United States, 08540
Contact: Janet Bergan    609-924-9200    willslaser@yahoo.com   
Principal Investigator: Anita Miedziak, MD         
United States, Ohio
Comprehensive Eye Care of Central Ohio Recruiting
Westerville, Ohio, United States, 43082
Contact: Ashley George    614-890-5692    AGeorge@Compeyecare.com   
Principal Investigator: Kenneth Beckman, MD         
United States, South Carolina
Medical University of South Carolina Storm Eye Institute, Magill Vision Center Not yet recruiting
Mt. Pleasant, South Carolina, United States, 29464
Contact: Carol Bradham    843-792-2338    bradhamc@musc.edu   
Principal Investigator: George Waring, MD         
United States, South Dakota
Vance Thompson Vision Recruiting
Sioux Falls, South Dakota, United States, 57105
Contact: Kelly Hall    605-371-7071    kelly.hall@vancethompsonvision.com   
Principal Investigator: Vance Thompson, MD         
United States, Utah
Hoopes Vision Recruiting
Draper, Utah, United States, 84020
Contact: Steven Linn    801-568-0200    steve@hoopesvision.com   
Principal Investigator: Robert Rivera, 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: NCT01344187     History of Changes
Other Study ID Numbers: KXL-001
Study First Received: April 27, 2011
Last Updated: July 16, 2014
Health Authority: United States: Food and Drug Administration

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

ClinicalTrials.gov processed this record on July 20, 2014