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

NCT02277054 | Completed Results

• 1 other identifier: 03/2013
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

Brief Summary

In this study the safety and effectiveness of biosynthetic cornea, comprising interpenetrating networks of recombinant human collagen and phosphorylcholine, will be tested in patients with severe corneal pathology (corneal ulcers or corneal opacification from corneal injury, burn or infection) - diseases, where human donor cornea transplantation (the only widely accepted treatment) carries a high risk of rejection.

Conditions

Corneal Ulcer; Leukoma

Outcome Measures

Primary Outcomes (1)

• Incidence of Treatment-Emergent Adverse Events

  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.

  12 months

Secondary Outcomes (2)

• Number of Participants With Healed Cornea at 12 Months

  12 months

• Number of Participants With Improved Visual Acuity at 12 Months

  12 months

Study Arms (1)

Collagen-MPC cornea substitute

EXPERIMENTAL

Collagen-phosphorylcholine (collagen-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique.

Device: Collagen-MPC cornea

Interventions

Collagen-MPC cornea DEVICE

Patients will undergo surgery using conventional anterior lamellar keratoplasty technique: diseased cornea will be trephined to approximately 50-90% of corneal thickness (depending on corneal ulcer or scar depth) and then a lamellar dissection will be created. Trephine diameter will depend on ulcer or leukoma maximal size. Alternatively a femtosecond laser may be used to create the dissection. A collagen-phosphorylcholine cornea 250-500 microns thick and equal or 0.25 mm larger diameter is placed and sutured. The sutures are superimposed and the implant and the sutures covered with a bandage contact lens. The sutures and bandage lens will be removed later after the initial healing period of 4 weeks or as determined by physician depending on the implant epithelial coverage.

Collagen-MPC cornea substitute

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects must sign and be given a copy of the written Informed Consent form.
• Subjects with best corrected distance visual acuity 20/200 or worse as a result of corneal ulcer or corneal scar due to burn, injury or infection in the operative eye.
• Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.

You may not qualify if:

• Subjects with severe or life-threatening systemic disease.
• Subjects with uncontrolled hypertension.
• Subjects with uncontrolled diabetes or insulin-dependent diabetes.
• Subjects with glaucoma in either eye.
• Subjects with marked microphthalmos or aniridia in either eye.
• Subjects with any other serious ocular pathology, serious ocular complications at the time of corneal transplant underlying serious medical conditions, based on the investigator's medical judgment.
• Subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.

Sponsors & Collaborators

• The Filatov Institute of Eye Diseases and Tissue Therapy: lead
• Linkoeping University: collaborator

Study Sites (1)

The Filatov Institute of Eye Diseases and Tissue Therapy

Odesa, 65061, Ukraine

Location

Related Publications (2)

• Liu W, Deng C, McLaughlin CR, Fagerholm P, Lagali NS, Heyne B, Scaiano JC, Watsky MA, Kato Y, Munger R, Shinozaki N, Li F, Griffith M. Collagen-phosphorylcholine interpenetrating network hydrogels as corneal substitutes. Biomaterials. 2009 Mar;30(8):1551-9. doi: 10.1016/j.biomaterials.2008.11.022. Epub 2008 Dec 20.

  PMID: 19097643 RESULT

• Hackett JM, Lagali N, Merrett K, Edelhauser H, Sun Y, Gan L, Griffith M, Fagerholm P. Biosynthetic corneal implants for replacement of pathologic corneal tissue: performance in a controlled rabbit alkali burn model. Invest Ophthalmol Vis Sci. 2011 Feb 3;52(2):651-7. doi: 10.1167/iovs.10-5224.

  PMID: 20847116 RESULT

MeSH Terms

Conditions

Corneal Ulcer; Corneal Opacity

Condition Hierarchy (Ancestors)

Eye Infections; Infections; Keratitis; Corneal Diseases; Eye Diseases

Results Point of Contact

• Title: Dr. Oleksiy Buznyk
• Organization: Filatov Institite of Eye Diseases and Tissue Therapy of the NAMS of Ukraine

a_buznik@bk.ru

+380487181548

Study Officials

• Nataliya Pasyechnikova, MD, PhD, DSc

  The Filatov Institute of Eye Diseases and Tissue Therapy

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 26, 2014
• First Posted: October 28, 2014
• Study Start: March 1, 2013
• Primary Completion: October 1, 2016
• Study Completion: January 1, 2017
• Last Updated: October 26, 2018
• Results First Posted: October 26, 2018

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

UA (1)