Evaluation of Safety and Efficacy of a Bioengineered Corneal Implant for Treatment of Keratoconus

NCT ID: NCT04653922

Last Updated: 2025-09-09

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-11-30
• Study Completion Date: 2023-07-31

Brief Summary

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.

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.

Conditions

Keratoconus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Bioengineered corneal substitute

A cell-free, sterilized bioengineered corneal substitute made from medical grade collagen

Group Type: EXPERIMENTAL

LinkCor Bioengineered Corneal Implant

Intervention Type: DEVICE

Intrastromal implantation of a bioengineered corneal equivalent device

Interventions

LinkCor Bioengineered Corneal Implant

Intrastromal implantation of a bioengineered corneal equivalent device

Intervention Type: DEVICE

Eligibility Criteria

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).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

LinkoCare Life Sciences AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Namrata Sharma, MD

Role: PRINCIPAL_INVESTIGATOR

ALL INDIA INSTITUTE OF MEDICAL SCIENCES, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS, New Delhi

Mahmoud Jabbarvand Behrouz, MD

Role: PRINCIPAL_INVESTIGATOR

University of Tehran, Farabi Eye Hospital

Locations

All India Institute of Medical Sciences, Dr. R. P. Centre for Ophthalmic Sciences, AIIMS,

New Delhi, , India

Farabi Eye Hospital, Tehran University of Medical Sciences

Tehran, , Iran

Countries

India; Iran

References

Rafat M, Jabbarvand M, Sharma N, Xeroudaki M, Tabe S, Omrani R, Thangavelu M, Mukwaya A, Fagerholm P, Lennikov A, Askarizadeh F, Lagali N. Bioengineered corneal tissue for minimally invasive vision restoration in advanced keratoconus in two clinical cohorts. Nat Biotechnol. 2023 Jan;41(1):70-81. doi: 10.1038/s41587-022-01408-w. Epub 2022 Aug 11.

Reference Type: RESULT

PMID: 35953672 (View on PubMed)

Other Identifiers

CMG-PRT-001

Identifier Type: -

Identifier Source: org_study_id