Corneal DiseasePhase 1NCT02374723
Evaluation of Biosynthetic Constructs to Replace Donor Corneas
A Phase 1 study testing NuCornea and donated human corneas in people with Corneal Disease, run by Region Östergötland.
Trial summary
Constructs made from cross-linked Human Recombinant Collagen type III are being used instead of human donor corneas in 6 patients at Deep anterior lamellar cornea grafting. Six patients serve as controls and are receiving human donor corneas using the same surgical technique. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Disease
- What is being tested?
- NuCornea and donated human corneas
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jun 2015to Apr 2016
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Indication for Deep anterior lamellar corneal transplantation.
- No topical Eye medication.
Who cannot join
- No Eye disease other than the indication for the corneal graft.
- No general disease that might affect the cornea.
- No general medication that might affect the cornea.
About this study
Official title: Evaluation of Biosynthetic Constructs as Replacement for Donor Corneas as Graft Material for Corneal Transplantation
Constructs made from cross-linked Human Recombinant Collagen type III are being used instead of human donor corneas in 6 patients at Deep anterior lamellar cornea grafting. Six patients serve as controls and are receiving human donor corneas using the same surgical technique. The twelve patients will be recruited from the local waiting list for patients to be undergoing corneal grafting. If the patients meet the inclusion criteria and agree to participate following oral and written consent, they will be randomized to either group. The patients will be followed for 12 months and documented with OCT, In Vivo Confocal Microscopy, slit lamp photography a o. The study is planned as a safety study with initial efficacy documentation.
Read the detailed description
12 patients will be recruited from the waitinglist for corneal transplantation.The will all be of the age of 18 years or older and capable of making their own decisions. Their medical history and present medication is reveiwed and they undergo a thorough ophthalmological examination in order to find out if they meet the inclusion criteria and create baseline values for the study. Their general health or medication should not affect the cornea or ocular surface. The Eye should be healthy with the exception of the disease indication for corneal grafting. The corneal endothelium should be healthy. Any opacification in the eye to be grafted should not reach the Descemets membrane. Visual acuity in the fellow eye should be good. If these criteria are met the patient recieve oral and written information of the study. If they agree to participate they will be randomized to either recieve biosynthetic corneas ( 6 patients) or they will recieve a donated cornea ( 6 patients) . They will be scheduled for surgery within 2 weeks from the examination irrespective if they participate in the study or not.
The surgery will be anterior deep lamellar using the femtosecond laser to do the patient cut. The laser cut wil be done in topical anaaestesi. The remaining surgery with either be performed in local oor general anaestesia according to the patients wish. The diameter of the cut will be 7 mm in diameter. The graft material will be punched to a diameter of 7.25 mm. The thickness of the material will be 500 µm . An amniotic membrane will be placed on the top of the biosynthetic material and sutured with single stiches together with the graft.A bandage lens will be placed . The donated corneas will be sutured with singled about 8 stiches.
The biosynthetic corneas will recieve topical antibiotics and dexametasone for 8 weeks when the sutures, remnants of the amniotic membrane and the bandage lens is removed. The donated corneas will recieve topical dexametasone for 5 months and the sutures will be removed after 6 months.
The check-up Schedule will be at 1 day,1,2 weeks,1,,2 months and extra when needed.The protocol in these check-ups will be descriptive and the exyes will be documented with slit lamp photography. Epitelialisation will be monitored with fluorescein staining.
At the 3,6,9 and12 months will be extensive and the same in both groups. UCVA and BSCVA will be measured and also BCLCVA at 12 months. Corrneal topography,thickness sensitivity,tear production Visante OCT and slit- lamp photography will be performed. Tear samples will be taken also form earlier check-ups for proteomic analysis. In vivo confocal microscopy will be performed. The different examination with few exceptions can all be presented in results that can be quantified and statistically analysed.
The CRFs and the adverse report forms will be filled out both on computer forms and on paper.
The safety outcome criteria are: Good engraftment, maintained integrity of the graft, epithelialisation, transparency,no induced inflammation,no induced vasculatisation.
The preliminary efficacy criteria are: UCVA,BSCVA and BCLCVA
- Conditions
- Corneal Disease
- Being tested
- NuCornea, donated human corneas
- Keywords
- improve, vision
- Medical subject headings
- Corneal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuCorneaDevice
Also called Biosynthetic cornea
Deep anterior lamellar corneal transplantation where the NuCornea is substituting a donor cornea
donated human corneasDevice
Deep anterior lamellar corneal transplantation with a donated cornea as graft material.
| Study group | Role | What they receive |
|---|---|---|
| NuCornea (Biosynthetic corneas) | Experimental | 6 patients will receive biosynthetic corneas when undergoing corneal transplantation Receives: Device: NuCornea |
| Donated human corneas | Active comparator | 6 patients will receive a donated human cornea when undergoing corneal transplantation Receives: Device: donated human corneas |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biocompatibility: Good engraftment,epithelialization, no neovascularization,retained transparency, no host inflammatory reaction
Device replacing human donor cornea at Deep anterior lamellar transplantation.
Measured: 1 year
Secondary outcomes (1)
Visual acuity
Best spectacle corrected visual acuity,Best contactlens corrected Visual acuity
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2015 (estimated)
- Study startJun 2015
- Primary completionApr 2016
- Study completionApr 2016
Why it stopped: This study was withdrawn to be replaced with a multi-site Phase I trial.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal DiseaseStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Östergötland
- Sponsor type
- University, hospital or other
- Collaborators
- The Swedish Research Council
- Responsible party
- Principal investigator, Per.Fagerholm, Region Östergötland
- Investigators
- Per Fagerholm, MD,PhD, Principal investigator, Dept of Ophthalmology, University Hospital, Linköping,Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02374723
- Sponsor's protocol ID
- DNr52120125706
- Status last verified
- Apr 2016
- First submitted
- 23 Feb 2015
- Last updated
- 15 Apr 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 15 Apr 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Biosynthetic Constructs as Replacement for Donor Corneas as Graft Material for Corneal Transplantation
- ClinicalTrials.gov ID
- NCT02374723
- Acronym / sponsor ID
- DNr52120125706
- Conditions
- Corneal Disease
- Keywords
- improve, vision
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: This study was withdrawn to be replaced with a multi-site Phase I trial.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Region ÖstergötlandUniversity, hospital or other
- Collaborators
- The Swedish Research Council
- Study start
- Jun 2015
- Primary completion
- Apr 2016 (actual)
- Study completion
- Apr 2016 (actual)
- First posted
- 2 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Constructs made from cross-linked Human Recombinant Collagen type III are being used instead of human donor corneas in 6 patients at Deep anterior lamellar cornea grafting. Six patients serve as controls and are receiving human donor corneas using the same surgical technique. The twelve patients will be recruited from the local waiting list for patients to be undergoing corneal grafting. If the patients meet the inclusion criteria and agree to participate following oral and written consent, they will be randomized to either group. The patients will be followed for 12 months and documented with OCT, In Vivo Confocal Microscopy, slit lamp photography a o. The study is planned as a safety study with initial efficacy documentation.
Detailed description
12 patients will be recruited from the waitinglist for corneal transplantation.The will all be of the age of 18 years or older and capable of making their own decisions. Their medical history and present medication is reveiwed and they undergo a thorough ophthalmological examination in order to find out if they meet the inclusion criteria and create baseline values for the study. Their general health or medication should not affect the cornea or ocular surface. The Eye should be healthy with the exception of the disease indication for corneal grafting. The corneal endothelium should be healthy. Any opacification in the eye to be grafted should not reach the Descemets membrane. Visual acuity in the fellow eye should be good. If these criteria are met the patient recieve oral and written information of the study. If they agree to participate they will be randomized to either recieve biosynthetic corneas ( 6 patients) or they will recieve a donated cornea ( 6 patients) . They will be scheduled for surgery within 2 weeks from the examination irrespective if they participate in the study or not.
The surgery will be anterior deep lamellar using the femtosecond laser to do the patient cut. The laser cut wil be done in topical anaaestesi. The remaining surgery with either be performed in local oor general anaestesia according to the patients wish. The diameter of the cut will be 7 mm in diameter. The graft material will be punched to a diameter of 7.25 mm. The thickness of the material will be 500 µm . An amniotic membrane will be placed on the top of the biosynthetic material and sutured with single stiches together with the graft.A bandage lens will be placed . The donated corneas will be sutured with singled about 8 stiches.
The biosynthetic corneas will recieve topical antibiotics and dexametasone for 8 weeks when the sutures, remnants of the amniotic membrane and the bandage lens is removed. The donated corneas will recieve topical dexametasone for 5 months and the sutures will be removed after 6 months.
The check-up Schedule will be at 1 day,1,2 weeks,1,,2 months and extra when needed.The protocol in these check-ups will be descriptive and the exyes will be documented with slit lamp photography. Epitelialisation will be monitored with fluorescein staining.
At the 3,6,9 and12 months will be extensive and the same in both groups. UCVA and BSCVA will be measured and also BCLCVA at 12 months. Corrneal topography,thickness sensitivity,tear production Visante OCT and slit- lamp photography will be performed. Tear samples will be taken also form earlier check-ups for proteomic analysis. In vivo confocal microscopy will be performed. The different examination with few exceptions can all be presented in results that can be quantified and statistically analysed.
The CRFs and the adverse report forms will be filled out both on computer forms and on paper.
The safety outcome criteria are: Good engraftment, maintained integrity of the graft, epithelialisation, transparency,no induced inflammation,no induced vasculatisation.
The preliminary efficacy criteria are: UCVA,BSCVA and BCLCVA
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| NuCornea (Biosynthetic corneas) | Experimental | Device: NuCornea6 patients will receive biosynthetic corneas when undergoing corneal transplantation |
| Donated human corneas | Active comparator | Device: donated human corneas6 patients will receive a donated human cornea when undergoing corneal transplantation |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Indication for Deep anterior lamellar corneal transplantation.
- No topical Eye medication.
Key exclusion criteria (3 listed)
- No Eye disease other than the indication for the corneal graft.
- No general disease that might affect the cornea.
- No general medication that might affect the cornea.
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 |
|---|---|---|
| NuCorneaAlso: Biosynthetic corneaDeep anterior lamellar corneal transplantation where the NuCornea is substituting a donor cornea | Device | NuCornea (Biosynthetic corneas) |
| donated human corneasDeep anterior lamellar corneal transplantation with a donated cornea as graft material. | Device | Donated human corneas |
Primary outcome
Biocompatibility: Good engraftment,epithelialization, no neovascularization,retained transparency, no host inflammatory reaction
Time frame: 1 year
Device replacing human donor cornea at Deep anterior lamellar transplantation.
1 secondary outcome
Visual acuity
Time frame: 1 year
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Apr 2016.
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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.
Per Fagerholm, MD,PhD principal investigator
Dept of Ophthalmology, University Hospital, Linköping,Sweden
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing NuCornea and donated human corneas in people with Corneal Disease, run by Region Östergötland.
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 2 inclusion and 3 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: withdrawn, as of the sponsor's last update on 15 Apr 2016. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
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?
Biocompatibility: Good engraftment,epithelialization, no neovascularization,retained transparency, no host inflammatory reaction (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 15 Apr 2016.