Corneal UlcersEarly Phase 1AmnioClipNCT02168790
Safety Study of a Sutureless Amniotic Membran Transplantation to Treat Ocular Surface Disorders (Expanded Access)
A Early Phase 1 study testing Amniotic membrane ring in people with Corneal Ulcers and Corneal Melting, run by Klinikum Chemnitz gGmbH at 1 site in Germany.
Trial summary
The investigators aimed at developing a technique to apply amniotic membrane to a diseased ocular surface without surgical intervention (sutureless amniotic membrane transplantation). This system needs to be concordant with laws and guidelines for the use of medical and pharmaceutical products. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Corneal Ulcers, Corneal Melting
- What is being tested?
- Amniotic membrane ring
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2011to Aug 2013
- Phase
- Early 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with ocular surface disorders and indication for amniotic membrane transplantation
- Willingness to provide signed Informed Consent Form
- For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
- Ability and willingness to return for all scheduled visits and assessments
Who cannot join
- An eye that, in the investigator's opinion, would not benefit from amniotic membrane transplantation
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Interventional Study to Investigate the Safety of a Combination of Amniotic Membrane and a Holder Device (AmnioClip) in the Therapy of Ocular Surface Disorders (Sutureless Amniotic Membrane Transplantation)
The investigators aimed at developing a technique to apply amniotic membrane to a diseased ocular surface without surgical intervention (sutureless amniotic membrane transplantation). This system needs to be concordant with laws and guidelines for the use of medical and pharmaceutical products.
Read the detailed description
A ring system (AmnioClip) was developed for mounting an amniotic membrane (AM) that can be applied like a large contact lens. AM is mounted between the two rings with a special designed, accessory mounting device. The safety of the ring system AmnioClip was tested in an interventional including 7 patients with ocular surface disorders and need for AM transplantation (1, 2, 3). About similar systems was reported (3, 4).
- Conditions
- Corneal Ulcers, Corneal Melting
- Being tested
- Amniotic membrane ring
- Keywords
- amniotic membrane holder, aminiotic membrane transplantation
- Medical subject headings
- Corneal Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Amniotic membrane ringDevice
Also called Amniotic membrane
The amniotic membrane ring system (AmnioClip) is device for sutureless application of amniotic membrane to oculare surfaces. Amniotic membrane is mounted between the two rings with a specially designed, accessory mounting device.
| Study group | Role | What they receive |
|---|---|---|
| Amniotic membrane ring | Experimental | Application of amniotic membrane device for 6-7 days. Receives: Device: Amniotic membrane ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slit lamp investigation of the inflammation status of the conjunctiva
The ring of the AmnioClip touches the conjunctiva of the ocular surface. To prove side effects through the medical device the conjunctiva is controlled at every visit with microscopy using a slit lamp.
Measured: Participants will be followed for the duration of hospital stay, an expanded average of 3 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jun 2014 (estimated)
- Study startFeb 2011
- Primary completionAug 2011
- Study completionAug 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Corneal UlcersStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- Klinikum Chemnitz gGmbH
- Sponsor type
- University, hospital or other
- Collaborators
- Technische Universität Dresden
- Responsible party
- Principal investigator, Katrin Engelmann, Klinikum Chemnitz gGmbH
- Investigators
- Ilya Kotomin, Study chair, Klinikum Chemnitz gGmbH
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02168790
- Sponsor's protocol ID
- SKC002AR01
- Acronym
- AmnioClip
- Status last verified
- Jun 2014
- First submitted
- 12 Jun 2014
- Last updated
- 20 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
1. Liu J, Sheha H, Fu Y et al. (2010) Update of amniotic membrane transplantation. Expert Review Ophthalmol 5:645-661 2. Dua HS, Azuara-Blanco A (1999) Amniotic membrane transplantation, Br J Ophthalmol 83:748-752 3. Daniel Meller, Mikk Pauklin, Henning Thomasen et al. (2011) Amniotic Membrane Transplantation in the Human Eye. Dtsch Arztebl Int 108: 243-8 4. Pachigolla G, Prasher P, Di Pasauale MA, Mc Culley JP, Mc Henry JG, Mootha VV, Evaluation of the role of ProKera in the mamagment of ocular surface and orbital disorders, Eye Contact Lens 2009, 35:172-175 5. Uhlig CE and Busse H, Development and evaluation of a device for sutureless and repeated application of amniotic memnbrane overlays. Cornea 29:331-5
Kotomin I, Valtink M, Hofmann K, Frenzel A, Morawietz H, Werner C, Funk RH, Engelmann K. Sutureless fixation of amniotic membrane for therapy of ocular surface disorders. PLoS One. 2015 May 8;10(5):e0125035. doi: 10.1371/journal.pone.0125035. eCollection 2015.
PubMed 25955359
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study to Investigate the Safety of a Combination of Amniotic Membrane and a Holder Device (AmnioClip) in the Therapy of Ocular Surface Disorders (Sutureless Amniotic Membrane Transplantation)
- ClinicalTrials.gov ID
- NCT02168790
- Acronym / sponsor ID
- AmnioClip / SKC002AR01
- Conditions
- Corneal Ulcers, Corneal Melting
- Keywords
- amniotic membrane holder, aminiotic membrane transplantation
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- Klinikum Chemnitz gGmbHUniversity, hospital or other
- Collaborators
- Technische Universität Dresden
- Study start
- Feb 2011
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2013 (actual)
- First posted
- 20 Jun 2014 (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.
The investigators aimed at developing a technique to apply amniotic membrane to a diseased ocular surface without surgical intervention (sutureless amniotic membrane transplantation). This system needs to be concordant with laws and guidelines for the use of medical and pharmaceutical products.
Detailed description
A ring system (AmnioClip) was developed for mounting an amniotic membrane (AM) that can be applied like a large contact lens. AM is mounted between the two rings with a special designed, accessory mounting device. The safety of the ring system AmnioClip was tested in an interventional including 7 patients with ocular surface disorders and need for AM transplantation (1, 2, 3). About similar systems was reported (3, 4).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Amniotic membrane ring | Experimental | Device: Amniotic membrane ringApplication of amniotic membrane device for 6-7 days. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with ocular surface disorders and indication for amniotic membrane transplantation
- Willingness to provide signed Informed Consent Form
- For sexually active women of childbearing potential, use of an appropriate form of contraception (or abstinence) for the duration of the study
- Ability and willingness to return for all scheduled visits and assessments
Key exclusion criteria (1 listed)
- An eye that, in the investigator's opinion, would not benefit from amniotic membrane transplantation
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 |
|---|---|---|
| Amniotic membrane ringAlso: Amniotic membraneThe amniotic membrane ring system (AmnioClip) is device for sutureless application of amniotic membrane to oculare surfaces. Amniotic membrane is mounted between the two rings with a specially designed, accessory mounting device. | Device | Amniotic membrane ring |
Primary outcome
Slit lamp investigation of the inflammation status of the conjunctiva
Time frame: Participants will be followed for the duration of hospital stay, an expanded average of 3 month
The ring of the AmnioClip touches the conjunctiva of the ocular surface. To prove side effects through the medical device the conjunctiva is controlled at every visit with microscopy using a slit lamp.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2014.
- Background1. Liu J, Sheha H, Fu Y et al. (2010) Update of amniotic membrane transplantation. Expert Review Ophthalmol 5:645-661 2. Dua HS, Azuara-Blanco A (1999) Amniotic membrane transplantation, Br J Ophthalmol 83:748-752 3. Daniel Meller, Mikk Pauklin, Henning Thomasen et al. (2011) Amniotic Membrane Transplantation in the Human Eye. Dtsch Arztebl Int 108: 243-8 4. Pachigolla G, Prasher P, Di Pasauale MA, Mc Culley JP, Mc Henry JG, Mootha VV, Evaluation of the role of ProKera in the mamagment of ocular surface and orbital disorders, Eye Contact Lens 2009, 35:172-175 5. Uhlig CE and Busse H, Development and evaluation of a device for sutureless and repeated application of amniotic memnbrane overlays. Cornea 29:331-5
- Derived from this study: PubMed 25955359Kotomin I, Valtink M, Hofmann K, Frenzel A, Morawietz H, Werner C, Funk RH, Engelmann K. Sutureless fixation of amniotic membrane for therapy of ocular surface disorders. PLoS One. 2015 May 8;10(5):e0125035. doi: 10.1371/journal.pone.0125035. eCollection 2015.
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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.
Ilya Kotomin study chair
Klinikum Chemnitz gGmbH
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Amniotic membrane ring in people with Corneal Ulcers and Corneal Melting, run by Klinikum Chemnitz gGmbH at 1 site in Germany.
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 4 inclusion and 1 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 20 Jun 2014. 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 Germany. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Slit lamp investigation of the inflammation status of the conjunctiva (time frame: Participants will be followed for the duration of hospital stay, an expanded average of 3 month). 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 NCT02168790, 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 20 Jun 2014.