Corneal UlcerNCT02277054

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

A study testing Collagen-MPC cornea in people with Corneal Ulcer and Leukoma, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 1 site in Ukraine.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: Corneal Ulcer, Leukoma
What is being tested?: Collagen-MPC cornea
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 5 participants
Where: 1 siteUkraine
Study dates: Mar 2013to Jan 2017
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Ukraine1 site

The Filatov Institute of Eye Diseases and Tissue Therapy
Odesa, 65061

Other trials in Ukraine

About this study

Official title: A Clinical Trial to Evaluate the Safety and Effectiveness of the Collagen-phosphorylcholine Corneal Substitutes in Patients Requiring Lamellar Keratoplasty

Read the 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.

Conditions: Corneal Ulcer, Leukoma
Being tested: Collagen-MPC cornea
Medical subject headings: Corneal Ulcer, Corneal Opacity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Collagen-MPC corneaDevice
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.

Study groups in NCT02277054
Study group	Role	What they receive
Collagen-MPC cornea substitute	Experimental	Collagen-phosphorylcholine (collagen-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique. Receives: Device: Collagen-MPC cornea

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 12 months

Secondary outcomes (2)

Number of Participants With Healed Cornea at 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
Measured: 12 months
Number of Participants With Improved Visual Acuity at 12 Months
Improvement of 1 or more lines in Corrected Distance Visual Acuity in comparison to preoperative visual acuity
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2013Jan 2017

First posted28 Oct 2014 (estimated)
Study startMar 2013
Primary completionOct 2016
Study completionJan 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Corneal UlcerStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 5 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02277054
Sponsor's protocol ID: 03/2013
Status last verified: Oct 2018
First submitted: 26 Oct 2014
Last updated: 26 Oct 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 19097643
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.
PubMed 20847116

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 26 Oct 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Clinical Trial to Evaluate the Safety and Effectiveness of the Collagen-phosphorylcholine Corneal Substitutes in Patients Requiring Lamellar Keratoplasty
ClinicalTrials.gov ID: NCT02277054
Acronym / sponsor ID: 03/2013
Conditions: Corneal Ulcer, Leukoma
Study type: Interventional
Recruitment status: Completed
Enrolment: 5 participants (actual)
Lead sponsor: The Filatov Institute of Eye Diseases and Tissue TherapyUniversity, hospital or other
Collaborators: Linkoeping University
Study start: Mar 2013
Primary completion: Oct 2016 (actual)
Study completion: Jan 2017 (actual)
First posted: 28 Oct 2014 (estimated)
Results: Posted 26 Oct 2018

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Collagen-MPC cornea substitute	Experimental	Device: Collagen-MPC corneaCollagen-phosphorylcholine (collagen-MPC) cornea substitute transplantation using anterior lamellar keratoplasty technique.

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Collagen-MPC corneaPatients 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.	Device	Collagen-MPC cornea substitute

Primary outcome

Incidence of Treatment-Emergent Adverse Events
Time frame: 12 months
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.

2 secondary outcomes

Number of Participants With Healed Cornea at 12 Months
Time frame: 12 months
Number of Participants With Improved Visual Acuity at 12 Months
Time frame: 12 months

Results and safety

Results posted to the registry on 26 Oct 2018, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
RHCIII-MPC Cornea Substitute	5	5

Primary outcome: Incidence of Treatment-Emergent Adverse Events

Time frame: 12 months. Number. Unit: events

Measure	RHCIII-MPC Cornea Substitute n = 5
Value	0

2 secondary outcomes are reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
RHCIII-MPC Cornea Substitute	0 of 5 (0%)	0 of 5 (0%)	Not reported

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Oct 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 19097643Liu 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.
Results publication: PubMed 20847116Hackett 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.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Nataliya Pasyechnikova, MD, PhD, DSc study director

The Filatov Institute of Eye Diseases and Tissue Therapy

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Collagen-MPC cornea in people with Corneal Ulcer and Leukoma, run by The Filatov Institute of Eye Diseases and Tissue Therapy at 1 site in Ukraine.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 26 Oct 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Ukraine. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 26 Oct 2018). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of Treatment-Emergent Adverse Events (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02277054, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Oct 2018.