- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04653922
Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus (LinkCor)
March 8, 2023 updated by: LinkoCare Life Sciences AB
Evaluation of Safety and Efficacy of Intrastromal Implantation of LinkCor Bioengineered Corneal Implant for Management and Treatment of Keratoconus: a Prospective, Non-randomized, Non-controlled Case Series.
This is a prospective, Phase I open-label safety study to evaluate the safety, feasibility and initial efficacy of a bioengineered corneal stromal substitute after implantation into the stroma of adults with advanced keratoconus.
The bioengineered substitute and implantation technique may provide a less invasive treatment option for advanced keratoconus than current surgical approaches, that additionally does not rely on the limited availability of human donor corneal tissue.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Detailed Description
This is a Phase I, open-label, non-randomized, non-controlled ongoing clinical case series in two participating centers in Indian and Iranian hospitals, to evaluate the safety and feasibility of minimally-invasive surgery of advanced keratoconus using a bioengineered corneal stromal substitute on a compassionate basis to alleviate blindness and low vision, due to the severely limited availability of human corneal donor tissue at these centers relative to the medical need.
Patients fulfilling inclusion criteria are recruited consecutively and implanted intra-stromally with the bioengineered substitute, as a less invasive surgery than full-thickness or anterior lamellar corneal transplantation.
In the first phase of the study, a total of 20 patients were recruited and safety and efficacy outcomes were evaluated in those having a minimum of 12 months of postoperative follow-up.
In the second phase of the study (currently ongoing), up to 40 patients are being recruited, with one-year postoperative outcomes of all included patients to be evaluated as the final study endpoint.
Primary safety and efficacy outcomes will be evaluated.
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Mehrdad Rafat, PhD
- Phone Number: +46734613166
- Email: mrafat@linkocare.com
Study Contact Backup
- Name: Neil Lagali, PhD
- Phone Number: +46 700 850 953
- Email: neil.lagali@liu.se
Study Locations
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New Delhi, India, 110029
- Recruiting
- All India Institute of Medical Sciences, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS,
-
Contact:
- Namrata Sharma, MD, DNB
- Phone Number: +91-011-26593144
- Email: namrata.sharma@gmail.com
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-
-
-
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Tehran, Iran, Islamic Republic of, 13366
- Recruiting
- Farabi Eye Hospital, Tehran University of Medical Sciences
-
Contact:
- Mahmoud Jabbarvand Behrouz, MD
- Phone Number: +989121014161
- Email: ma.jabarvand@gmail.com
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-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Advanced keratoconus (according to Amsler-Krumeich classification)
- No corneal scar
- Male or female aged ≥ 18 years, no upper age limit
- Subjects indicated for a first corneal stromal transplantation (treatment naïve)
- Corneal thickness (including epithelium) at least 300µm centrally, as measured by OCT.
- Patients who gave their written signed and dated informed consent for participation
Exclusion Criteria:
- Prior corneal surgery (e.g., refractive surgery, cataract, collagen cross-linking, endothelial keratoplasty, etc.)
- Dry eye / tear film pathology
- Active ocular infection
- Glaucoma / ocular hypertension
- Active corneal ulceration
- Acute or chronic disease or illness that would increase the operation risk or confound the outcomes of the study (immune- compromised, connective tissue disease, clinically significant atopic disease, etc.)
- Any other medical condition that in the judgment of the clinical investigator or corneal surgeon is not compatible with the study procedures
- General history judged by the investigator to be incompatible with the study (e.g., life-threatening patient condition, other condition where postoperative follow-up may be difficult).
- known diabetes or other neuro-degenerative disorder (as corneal nerves can be affected leading to impaired wound healing)
- Inability of patient to understand the study procedures and thus inability to give informed consent.
- Participation in another clinical study within the last 3 months
- Already included once in this study (can only be included for one treated eye).
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Bioengineered corneal substitute
A cell-free, sterilized bioengineered corneal substitute made from medical grade collagen
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Intrastromal implantation of a bioengineered corneal equivalent device
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Safety outcome measure
Time Frame: 6 months
|
The primary safety endpoint is defined such that a rejection leading to implant removal should occur in no more than 10% of implanted eyes.
The implant rejection is defined as a clinical situation when the implanted eye has decreased central corneal clarity and decreased implant clarity, corneal vascularization inside of laser created pocket and inflammation.
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6 months
|
Corneal curvature measured by keratometry (efficacy measure)
Time Frame: 6 months
|
The maximum and minimum corneal curvature (steepness) of each eye will be measured by a keratometer and reported in diopter (D) unit and represented as "K-value".
The efficacy outcome is that more than 60% of the eyes should have a decrease in K-value at 6 months postoperatively.
|
6 months
|
Central corneal thickness measured by topography techniques (efficacy measure)
Time Frame: 6 months
|
Central corneal thickness (CCT) will be measured in microns and reported using a two-dimensional thickness map made by optical coherence tomography (OCT) and/or Pentacam topography.
The efficacy outcome is that more than 60% of the eyes should have an increase in CCT at 6 months postoperatively.
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6 months
|
Visual acuity (efficacy measure)
Time Frame: 6 months
|
Vision improvement equivalent of minimum one line in Snellen chart in uncorrected distance visual acuity (UDVA) or corrected distance visual acuity (CDVA).
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6 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Namrata Sharma, MD, ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi
- Principal Investigator: Mahmoud Jabbarvand Behrouz, MD, University of Tehran, Farabi Eye Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 1, 2016
Primary Completion (Anticipated)
December 31, 2023
Study Completion (Anticipated)
July 31, 2024
Study Registration Dates
First Submitted
November 23, 2020
First Submitted That Met QC Criteria
December 3, 2020
First Posted (Actual)
December 4, 2020
Study Record Updates
Last Update Posted (Estimate)
March 10, 2023
Last Update Submitted That Met QC Criteria
March 8, 2023
Last Verified
April 1, 2022
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMG-PRT-001
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
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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