SINGLE PATIENT EXPANDED ACCESS OF A PROSPECTIVE, MULTICENTER CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND PROBABLE BENEFIT OF THE KERAKLEAR NON-PENETRATING KERATOPROSTHESIS IN SUBJECTS WITH CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT

This is for a "Single Patient Expanded Access" of an on-going study (IRB#2017-3526). In the on-going study, the maximum number of subject will be 35 subjects (35 eyes) will be implanted with the KeraKlear device and will be followed for one year. However, this expanded access is for single patient use below is a description of patient condition and circumstances necessitating treatment:

88 year old female with 2 previous failed corneal transplants, had significant scarring and mild edema, surface well epithelialized, has potential for 10 letters of improvement in visual acuity. Patient is high risk for recurrent corneal rejection and failure and therefore would not be a candidate for standard corneal transplant. She would potentially do well with a partial thickness artificial cornea such as the KeraKlear.

Study Overview

• Status: Withdrawn
• Conditions: CORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANT
• Intervention / Treatment: Other: Experimental

Detailed Description

For this "Single Patient Expanded Access" the research procedures will be based on the Master Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study visit. This patient is 88 years old as of the submission of this Protocol Narrative to the IRB.

Postoperatively, subject will be examined at (with window size in parentheses):

• 1 Day (+2 days)
• 1 Week (7±2 days)
• 1 Month (30±5 days)
• 2 Months (60±7 days)
• 3 Months (90±7 days)
• 4 Months (120±10 days)
• 6 Months (180±10 days)
• 9 Months (270±20 days)
• 12 Months (360±20 days)

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Irvine, California, United States, 92697
      • University of California Irvine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 88 years to 88 years (Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

• Corneal blindness where cornea transplantation is necessary but is expected to be unsuccessful due to severe limbal stem cell deficiency (LSCD) associated with aniridia or due to multiple (two or more) failed cornea transplantation surgeries and spontaneous visual improvement without surgical intervention is not expected or probable.
• Best Corrected Distance Visual Acuity (Snellen) which is equal or worse than 20/200 in the study eye (but at least light perception with projection)
• Estimated visual potential of the study eye is greater than or equal to at least two lines visual improvement of BCDVA of current vision in the study eye.

Exclusion Criteria:

• Visual Acuity of No Light Perception (NLP) in the study eye
• The patient is monocular or the non-study eye has Best Corrected Distance Visual Acuity (Snellen) of worse than 20/160 due to an ocular condition other than severe aniridic limbal stem cell deficiency or due to multiple (two or more) failed cornea transplantation surgeries.
• Suitable for standard PK with donor tissue in the study eye.
• History of severe dry eye syndrome or a Schirmer test with results of less than 3mm after 5 minutes of testing with the use of topical anesthetic in either eye.
• Active or history of an auto-immune disease (e.g. Rheumatoid Arthritis, Ocular Cicatricial Pemphigoid, Lupus, Steven's Johnson Syndrome, atopic keratoconjunctivitis, etc.).
• On medications that may affect wound healing, such as antimetabolites or other chemotherapeutic agents.
• History of posterior segment eye disease in either eye (including macular degeneration, optic neuropathy, posterior uveitis) which is expected to limit the visual improvement to less than two lines of vision.
• History of retinal surgery in the fellow eye (including retinal detachment repair, intravitreal injection etc.).
• History of retinal surgery in the study eye (including retinal detachment repair, intravitreal injection, etc.) unless the vision is at least light perception with projection in four field quadrants and the macula is attached (if there is no view of the retina, an ultrasound must show the macula is attached).
• History of uncontrolled glaucoma in either eye (IOP has been measured above 25 mmHg at any time in the last 6 months).
• Current use of beta blocker eye drops (e.g. timolol, levobunolol, etc.).
• Vertical cup-to-disc (C:D) ratio greater than or equal to 0.8 in either eye (if able to visible through corneal opacity). If not visible, patient is not to be excluded.
• Limited visual potential (patient does not have the ability to improve a minimum of two lines of vision of BCDVA by history).
• History of amblyopia in the study eye limiting visual potential.
• If the patient has had a corneal transplant, corneal transplantation surgery was performed less than 2 years ago.
• Anticipated need for surgery on the study eye during the course of the study (including cataract surgery).
• Aphakia in the study eye.
• Active ocular infection in either eye.
• Hypotony in the study eye (IOP < 6mmHg).
• History of herpetic ocular infection in the study eye.
• Corneal thickness less than 400 microns in any region of the pachymetry map.
• Inability to protect the operated eye from trauma.
• Females who are pregnant, lactating, or unwilling to use adequate birth control for t the duration of the study.
• Patient is currently taking Sumatriptan (Imitrex) and unable to discontinue during the study.

For this "Single Patient Expanded Access" the research procedures will be based on the Master Protocol Version #1.2 dated 18Dec2017, with one foreseen deviation. Section 7.1 Page 27 under Inclusion Criteria #1 Male or female from 22 years to 80 years of age at screening study visit. This patient is 88 years old.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
1.Improvement in BCDVA compared to baseline [ Time Frame: Baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9 and Month 12 ]	Best Corrected Distance Visual Acuity (BCDVA) will be measured in the study eye. An ETDRS visual acuity chart will be used to measure BCDVA at baseline, Month 1, Month 2, Month 3, Month 4, Month 6, Month 9, and Month 12.	1 year

Collaborators and Investigators

• Sponsor: University of California, Irvine

Study record dates

Study Major Dates

• Study Start (Actual): August 10, 2018
• Primary Completion (Actual): August 9, 2019
• Study Completion (Actual): August 9, 2019

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 18, 2019
• First Posted (Actual): January 23, 2019

Study Record Updates

• Last Update Posted (Actual): May 27, 2020
• Last Update Submitted That Met QC Criteria: May 22, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Eye Diseases; Corneal Diseases; Corneal Opacity
• Other Study ID Numbers: 2018-4549

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No