Clinical trial NCT02424006: Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea in Patients Requiring Anterior Lamellar Keratoplasty
Official title: A Prospective, Randomized, Open Label Clinical Trial to Evaluate the Safety and Effectiveness of the RHCIII-MPC Biosynthetic Cornea Compared to Human Cornea in Patients Requiring Anterior Lamellar Keratoplasty
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Leukoma
Keywords: keratoplasty
bioengineered cornea
donor cornea
Lead sponsor: L.V. Prasad Eye Institute
Sponsor class: OTHER
Collaborators: name: Linkoeping University
First posted: 2015-04-22
Enrollment: 2
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: RHCIII-MPC Biosynthetic Cornea
Primary purpose: TREATMENT

Brief summary: In this study safety and effectiveness of bioengineered cornea comprising of interpenetrating networks of recombinant human type III collagen and synthetic phospholipid - phosphorylcholine - will be tested in patients with corneal scars (leukomas) after infection, trauma or keratoconus. Control group will consist of patients with the same condition who will undergo corneal transplantation - current standard of care.

Detailed description: Recently developed and passed extensive pre-clinical testing collagen-phosphorylcholine(RHCIII-MPC) corneal substitute will be implanted in patient's corneas with corneal scar (leukoma) developed after infection, trauma or keratoconus using anterior lamellar keratoplasty technique, i.e. once patient's diseased anterior part of cornea is removed, either manually or with assistance of femtosecond laser, it will be substituted with proposed transparent implant. Control patients with same condition will be grafted with human donor cornea using the same surgical technique.

The investigators will test the safety and the effectiveness of developed biosynthetic corneas. Overall 20 patients are planned to recruit. They will be randomized in two groups - 10 patients will undergo RHCIII-MPC cornea implantation, another 10 will be impanted with human donor cornea. The patients will be follow-uped for 12 months.

Eligibility criteria: Inclusion Criteria:

* Subjects must sign and be given a copy of the written Informed Consent form.
* Subjects with best corrected distance visual acuity +1.0 LogMAR or worse as a result of corneal scar due to infection, injury or keratoconus in the operative eye.
* Subjects must be willing and able to return for scheduled follow-up examinations for 12 months after surgery.

Exclusion Criteria:

* 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 surgery 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.

Primary outcomes:
measure: Safety (Degree of eye inflammation)
timeFrame: 12 months
Secondary outcomes:
measure: Biocompatability, degree of haze and/or vascularisation measured on a scale 0-4
timeFrame: 12 months
measure: Visual acuity measured by LogMAR
timeFrame: 12 months
Other outcomes:
Locations:
city: Hyderabad
country: India
facility: L V Prasad Eye Institute, Centre for Ocular Regeneration
Study officials:
affiliation: LV Prasad Eye Institute
name: Virender S Sangwan, MBBS, MS
role: PRINCIPAL_INVESTIGATOR
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: Fagerholm P, Lagali NS, Ong JA, Merrett K, Jackson WB, Polarek JW, Suuronen EJ, Liu Y, Brunette I, Griffith M. Stable corneal regeneration four years after implantation of a cell-free recombinant human collagen scaffold. Biomaterials. 2014 Mar;35(8):2420-7. doi: 10.1016/j.biomaterials.2013.11.079. Epub 2013 Dec 25.