A prospective, multicenter clinical trial designed to evaluate the safety and probable benefit of the keraklear non-penetrating keratoprosthesis in subjects with corneal opacity due to severe limbal stem cell deficiency associated with aniridia
- Sponsor and address
4122 East Chapman Avenue
2nd Floor, Suite 26
Orange, CA 92869Tel: 973-276-1414
- Study title
A PROSPECTIVE, MULTICENTER CLINICAL TRIAL DESIGNED TO EVALUATE THE SAFETY AND PROBABLE BENEFIT OF THE KERAKLEAR NON-PENETRATING KERATOPROSTHESIS IN SUBJECTS WITH CORNEAL OPACITY DUE TO SEVERE LIMBAL STEM CELL DEFICIENCY ASSOCIATED WITH ANIRIDIA
- Protocol nº
ANIRIDIA001 Version 01. Date: 28 March 2017
- Principal Investigator and address.
Dr. Jorge L. Alió
Calle Cabañal, 1
Tel: 0034 965154062
Fax: 0034 965151501
- Centers where the study will take place
Calle Cabañal, 1
- Evaluating IRB
CAEC (Comité Ético Autonómico de Estudios Clínicos de Medicamentos y Productos Sanitarios de la Comunitat Valenciana)
Dirección General de Farmacia y Productos Sanitarios
C/ Micer Mascó, 31
- Principal objective
To demonstrate the safety and performance of the KeraKlear Non-Penetrating Keratoprosthesis in patients with corneal blindness due to severe limbal stem cell deficiency (LSCD) associated with aniridia.
This is a prospective, single center, single arm, open-label clinical trial, designed to demonstrate the safety and performance of the KeraKlear Non-Penetrating Keratoprosthesis. Approximately 20 subjects will be enrolled to account for subjects who sign the Informed Consent Document but fail to meet the eligibility criteria and are discontinued from the study as a screen failure. A maximum of 20 subjects (20 eyes) will be implanted with the KeraKlear device. Patients with corneal blindness due to severe limbal stem cell deficiency (LSCD) associated with aniridia will be screened for study participation. Screening procedures will include measurement of uncorrected visual acuity, best-corrected visual acuity, manifest refraction, Schirmer Testing, intraocular pressure measurement, corneal pachymetry, dilated fundus examination including optic nerve assessment, and slit lamp biomicroscopy.
Eligible subjects who have provided written informed consent will then be enrolled and scheduled for implantation of the KeraKlear Implant. A copy of the Informed Consent Document is provided in Appendix Two.
Postoperatively, subjects 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)
Each study examination will include measurement of uncorrected visual acuity, best-corrected visual acuity, manifest refraction, intraocular pressure measurement, Anterior Segment Optical Coherence Tomography (OCT), dilated fundus examination including optic nerve assessment, and slit lamp biomicroscopy. Adverse events will also be recorded at each visit, as well as any unscheduled visits that occur during the study.
- Disease under investigation
Patients with corneal blindness due to severe limbal stem cell deficiency (LSCD) associated with aniridia.
- Information regarding medication under study
No pharmaceutical product is under evaluation in this study.
The medical device in evaluation in this study is the KeraKlear® Non-Penetrating Keratoprosthesis. The application of this medical device in this study is covered by the CE mark 0459 as indicated in the enclosed certificate.
- Study population and total number of subjects
The study population will consist of 20 adult subjects from 22 years to 80 years of age with corneal blindness (Best Corrected Snellen visual acuity equal to or worse than 20/200) where cornea transplantation is necessary but is expected to be unsuccessful due to severe limbal stem cell deficiency (LSCD) associated with aniridia. Only one eye is to be enrolled. If both eyes qualify, the eye with worse Best Corrected Distance Visual Acuity is to be enrolled.
- Male or female from 22 years to 80 years of age at screening study visit.
- Corneal blindness where cornea transplantation is necessary but is expected to be unsuccessful due to severe limbal stem cell deficiency (LSCD) associated with aniridia.
- 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.
- Patient and/or caregiver willing and able to insert and remove bandage contact lens.
- Negative serum pregnancy test for females of child bearing potential.
- Willing and able to give consent and sign the consent form.
- Willing and able to comply with all protocol defined procedures including use of post-operative medication and return to the office for all study visits.
- 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).
- 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 the duration of the study.
- Patient is currently taking Sumatriptan (Imitrex) and unable to discontinue during the course of the study.
- Participation in an investigational study, device or drug, within the last 30 days.
- Known allergy to any of the medications used during study procedures, surgical procedure, or post-operative care.
- Any known allergy to the materials or cleaning solutions of the implant (acrylic) or bandage contact lens.
- Active smoking habit (enrolled subjects should be cautioned regarding exposure to smoke from environmental or occupational sources)
- There is reason to believe the patient and/or caregiver would not use the prescribed post-operative regimen (medication and contact lens use) as directed. Patient has a history of medication non-compliance or dementia.
- Presence of any condition, abnormality, or situation at screening that in the opinion of the investigator precludes the patient’s ability to comply with the study requirements, including completion of the study or the quality of the data. Reason for exclusion should be documented on CRF.
- History of uncontrolled glaucoma in either eye (IOP has been measured above 25 mmHg at any time in the last 6 months)
- Funding source
This study will be fully supported by KeraMed, Inc.
- Work plan
As soon as this study is approved by all the required authorities the working plan will be as follow:
- Inclusion period of patients: Month 0 – 6
- Implantation of the First patient: Month 1
- Implantation of the last patient: Month 7
- Start of clinical follow up of the implanted patients: Month 1
- End of clinical follow up of the implanted patients: Month 19
- Report of the clinical study: Month 20
- General objectives and specifics. Fundamentals
The objectives are the evaluation of the performance and safety of the KeraMed Implant as follows:
- Improvement in BCDVA compared to baseline
- Ocular Adverse Events
- Slit Lamp and Fundus Findings
- Reduction in BCDVA from baseline