Clinical trial NCT02277054: Safety and Effectiveness of Collagen-phosphorylcholine Bioengineered Cornea in Patients Requiring Lamellar Keratoplasty
Official title: A Clinical Trial to Evaluate the Safety and Effectiveness of the Collagen-phosphorylcholine Corneal Substitutes in Patients Requiring Lamellar Keratoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Corneal Ulcer
Leukoma
Lead sponsor: The Filatov Institute of Eye Diseases and Tissue Therapy
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2014-10-28
Enrollment: 5
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Detailed description: Collagen-phosphorylcholine corneal substitute will be implanted in patient's corneas with severe pathology (corneal ulcer, corneal leukoma after burn, trauma or infection) using anterior lamellar keratoplasty technique, i.e. when patient's diseased cornea is removed it will be substituted with proposed transparent implant. Usually these patients are grafted with human donor cornea, but the latter frequently fails due to graft-versus-host problems. We will test the safety (incidence of adverse events, biocompatability) and the effectiveness (ability to promote healing and increase vision) of developed biosynthetic corneas in 10 patients with corneal pathology, where human donor cornea carries a high risk of rejection. The patients will be follow-uped for 12 months.

Eligibility criteria: Inclusion Criteria:

1. Subjects must sign and be given a copy of the written Informed Consent form.
2. 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.
3. Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.

Exclusion Criteria:

1. Subjects with severe or life-threatening systemic disease.
2. Subjects with uncontrolled hypertension.
3. Subjects with uncontrolled diabetes or insulin-dependent diabetes.
4. Subjects with glaucoma in either eye.
5. Subjects with marked microphthalmos or aniridia in either eye.
6. 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.
7. Subjects which are or lactating or who plan to become pregnant over the course of the clinical investigation.

Primary outcomes:
measure: Incidence of Treatment-Emergent Adverse Events
timeFrame: 12 months
Secondary outcomes:
measure: Number of Participants With Healed Cornea at 12 Months
timeFrame: 12 months
measure: Number of Participants With Improved Visual Acuity at 12 Months
timeFrame: 12 months
Other outcomes:
Locations:
city: Odessa
country: Ukraine
facility: The Filatov Institute of Eye Diseases and Tissue Therapy
Study officials:
affiliation: The Filatov Institute of Eye Diseases and Tissue Therapy
name: Nataliya Pasyechnikova, MD, PhD, DSc
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.