Trial Outcomes & Findings for Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty (NCT NCT02277054)

Last Updated: 2018-10-26

Results Overview

Implant safety and tolerability will be measured by absence/presence of its lysis as well as by degree of eye inflammation based on conjunctival injection, perifocal corneal haze, aqueous humor transparency, increased intraocular pressure and self reported postoperative pain. Each item is scored 0-4: 0 = no symptom, 4 = severe symptom.

Recruitment status

COMPLETED

Study phase

Target enrollment

5 participants

Primary outcome timeframe

12 months

Results posted on

2018-10-26

Participant Flow

Participant milestones

Participant milestones
Measure	RHCIII-MPC Cornea Substitute Recombinant human collagen type III -methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique. Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 350 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures were superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.
Overall Study STARTED	5
Overall Study COMPLETED	5
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	RHCIII-MPC Cornea Substitute n=5 Participants Recombinant human collagen type III -methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique. Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 250-500 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	3 Participants n=5 Participants
Age, Categorical >=65 years	2 Participants n=5 Participants
Sex: Female, Male Female	2 Participants n=5 Participants
Sex: Female, Male Male	3 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	5 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment Ukraine	5 participants n=5 Participants

PRIMARY outcome

Timeframe: 12 months

Outcome measures

Outcome measures
Measure	RHCIII-MPC Cornea Substitute n=5 Participants Recombinant human collagen type III-methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique. Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 350 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures were superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.
Incidence of Treatment-Emergent Adverse Events	0 events

SECONDARY outcome

Timeframe: 12 months

Cornea is considered to have healed up when there is no defect of corneal epithelium, which is confirmed by fluorescein staining of corneal surface

Outcome measures

Outcome measures
Measure	RHCIII-MPC Cornea Substitute n=5 Participants Recombinant human collagen type III-methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique. Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 350 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures were superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.
Number of Participants With Healed Cornea at 12 Months	5 Participants

SECONDARY outcome

Timeframe: 12 months

Improvement of 1 or more lines in Corrected Distance Visual Acuity in comparison to preoperative visual acuity

Outcome measures

Outcome measures
Measure	RHCIII-MPC Cornea Substitute n=5 Participants Recombinant human collagen type III-methylphosphorylcholine (RHCIII-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique. Patients underwent surgery using conventional anterior lamellar keratoplasty technique: diseased cornea was trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection was created. Trephine diameter depended on ulcer or leukoma maximal size. A RHCIII-MPC cornea 350 microns thick and equal or 0.25 mm larger diameter was placed and sutured. The sutures were superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens were removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.
Number of Participants With Improved Visual Acuity at 12 Months	3 Participants

Adverse Events

RHCIII-MPC Cornea Substitute

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Oleksiy Buznyk

Filatov Institite of Eye Diseases and Tissue Therapy of the NAMS of Ukraine

Phone: +380487181548

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place