Chemical InjuriesPhase 1/2NCT01582880

Use of Cross-linked Donor Corneas as Carriers for the Boston Keratoprosthesis

A Phase 1/2 study testing Riboflavin in people with Chemical Injuries and Unspecified Complication of Corneal Transplant, run by Joseph B. Ciolino, MD at 1 site in United States.

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

The purpose of the pilot study is to test the efficacy and safety of riboflavin/Ultraviolet A (UVA) cross-linked human donor corneas as carriers for the Boston Keratoprosthesis (Boston KPro) in patients with higher risk for corneal melting (keratolysis). Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chemical Injuries, Unspecified Complication of Corneal Transplant, Autoimmune Diseases
What is being tested?: Riboflavin
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1 participants
Where: 1 siteUnited States
Study dates: Mar 2012to Mar 2014
Phase: Phase 1/2
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 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Age > 18 years.
A negative urine pregnancy test.
Candidate for a Boston Keratoprosthesis/Corneal transplant.
Generally good stable overall health.
Patients with an eye at risk for a cornea sterile ulcer which includes:

Show all 9Show fewer

Chemical injuries.
Autoimmune diseases (ocular cicatricial pemphigoid, Stevens Johnson Syndrome, systemic lupus erythematosus, rheumatoid arthritis, or other autoimmune diseases).
History of previous sterile corneal ulceration requiring a cornea transplant.

Who cannot join

Age < 18 years.
Inability to provide written informed consent and comply with study assessments for the full duration of the study.
Pregnant or lactating women.
No or minimal tear production.
Ocular or periocular malignancy.
Inability to wear a contact lens due to lid abnormalities or shortened fornix.
Signs of current infection, including fever and current treatment with antibiotics.
Participation in another simultaneous medical investigation or trial

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts Eye and Ear Infirmary
Boston, Massachusetts, 02114

Other trials in United States

About this study

Official title: The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis

Read the detailed description

The corneal cross-linking technique has been shown to strengthen the cornea and resist degradation by the body's own enzymes. The use of highly-resistant donor corneas is meant to eliminate the serious post-operative complication of corneal melting (keratolysis) that repeatedly occurs in Boston KPro patients with severe ocular burns, autoimmune and cicatrizing diseases.

Conditions: Chemical Injuries, Unspecified Complication of Corneal Transplant, Autoimmune Diseases, Ocular Cicatricial Pemphigoid, Stevens Johnson Syndrome, Lupus Erythematosus, Systemic
Being tested: Riboflavin
Keywords: Keratoprosthesis, sterile cornea ulcer
Medical subject headings: Autoimmune Diseases, Pemphigoid, Benign Mucous Membrane, Stevens-Johnson Syndrome, Lupus Erythematosus, Systemic, Arthritis, Rheumatoid

What participants receive

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

RiboflavinDrug
Also called Riboflavin (vitamin B2) 0.1% solution
Used to treat donor cornea before implantation

Study groups in NCT01582880
Study group	Role	What they receive
Riboflavin Cross-linked donor cornea	Experimental	the donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis. Receives: Drug: Riboflavin

What is being measured

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

Changes in Corneal Thickness at 1 Millimeter
The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.
Measured: measured at week 4, 6, 26, 32, 52
Changes in Corneal Thickness at 2 Millimeter
The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.
Measured: measured at week 4, 6, 26, 32, 52

Secondary outcomes (3)

Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers
Number of occurrence of vitritis (sterile or infectious) ulcers. Incidences of ulcers were collected by way of slit lamp photography from time of surgery to final visit.
Measured: post op week 52
Ocular Safety
Incidence and severity of ocular adverse events during the study (ophthalmic examination, adverse events spontaneously reported)
Measured: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52
Systemic Safety
Incidence and severity of systemic adverse events during the study (clinical laboratory, adverse events spontaneously reported).
Measured: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52

Timeline

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

Mar 2012Mar 2014

First posted23 Apr 2012 (estimated)
Study startMar 2012
Primary completionMar 2014
Study completionMar 2014

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.
Other trials for Chemical InjuriesStudies 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 1 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT01582880
Sponsor's protocol ID: 10-03-020
Status last verified: Oct 2019
First submitted: 10 Apr 2012
Last updated: 21 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

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?

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Study at a glance

From the registry record, last updated by the sponsor on 21 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: The Use of Riboflavin/Ultraviolet A Cross-linked Human Donor Corneas as Carriers for the Boston Keratoprosthesis
ClinicalTrials.gov ID: NCT01582880
Acronym / sponsor ID: 10-03-020
Conditions: Chemical Injuries, Unspecified Complication of Corneal Transplant, Autoimmune Diseases, Ocular Cicatricial Pemphigoid, Stevens Johnson Syndrome, Lupus Erythematosus, Systemic
Keywords: Keratoprosthesis, sterile cornea ulcer
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 1 participants (actual)
Lead sponsor: Joseph B. Ciolino, MDUniversity, hospital or other
Study start: Mar 2012
Primary completion: Mar 2014 (actual)
Study completion: Mar 2014 (actual)
First posted: 23 Apr 2012 (estimated)
Results: Posted 24 Jul 2017

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
Riboflavin Cross-linked donor cornea	Experimental	Drug: Riboflavinthe donor cornea used as a carrier for the Boston Keratoprosthesis will undergo crosslinking treatment before being trephined and prepared for implantation with the Keratoprosthesis.

Who may qualify

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

Key inclusion criteria (9 listed)

Ability to provide written informed consent and comply with study assessments for the full duration of the study.
Age > 18 years.
A negative urine pregnancy test.
Candidate for a Boston Keratoprosthesis/Corneal transplant.
Generally good stable overall health.

Key exclusion criteria (8 listed)

Age < 18 years.
Inability to provide written informed consent and comply with study assessments for the full duration of the study.
Pregnant or lactating women.
No or minimal tear production.
Ocular or periocular malignancy.

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
RiboflavinAlso: Riboflavin (vitamin B2) 0.1% solutionUsed to treat donor cornea before implantation	Drug	Riboflavin Cross-linked donor cornea

Primary outcome

Changes in Corneal Thickness at 1 Millimeter
Time frame: measured at week 4, 6, 26, 32, 52
The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 1 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.
Changes in Corneal Thickness at 2 Millimeter
Time frame: measured at week 4, 6, 26, 32, 52
The average carrier graft thickness over the first year of postoperative follow-up. The corneal thickness was measured at each visit using AS-OCT imaging 2 mm away from the KPro stem at 3, 6, 9, and 12 o'clock. The individual corneal thickness measurements (3, 6, 9, and 12 o'clock) where then averaged. The average corneal thickness measurements for week 4, 6, 26, 32 and 52 are reported below.

3 secondary outcomes

Number of Occurrences of Vitritis (Sterile or Infectious) Ulcers
Time frame: post op week 52
Ocular Safety
Time frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52
Systemic Safety
Time frame: measured at day 1, and week 1, 4, 8, 12, 16, 24, 36, 52

Results and safety

Results posted to the registry on 24 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Riboflavin Cross-linked Donor Cornea	1	1

Primary outcome: Changes in Corneal Thickness at 1 Millimeter

Time frame: measured at week 4, 6, 26, 32, 52. Number. Unit: micrometer

Measure	Riboflavin Cross-linked Donor Cornea n = 1
week 4 corneal thickness	730
week 6 corneal thickness	760
week 26 corneal thickness	700
week 32 corneal thickness	720
week 52 corneal thickness	680

Population analysed: 52 year old white male patient

Primary outcome: Changes in Corneal Thickness at 2 Millimeter

Time frame: measured at week 4, 6, 26, 32, 52. Number. Unit: micrometer

Measure	Riboflavin Cross-linked Donor Cornea n = 1
week 4 corneal thickness	940
week 6 corneal thickness	860
week 26 corneal thickness	820
week 32 corneal thickness	795
week 52 corneal thickness	780

Population analysed: 52 year old white male patient

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: This study enrolled one study subject. The study subject was followed for Adverse Events from the time of signing the study informed consent form 2/12/2013 to one year post surgery 3/13/2014. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Riboflavin Cross-linked Donor Cornea	0 of 1 (0%)	0 of 1 (0%)	0 of 1

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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.

Joseph Ciolino, MD principal investigator

Massachusetts Eye and Ear Infirmary

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

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Riboflavin in people with Chemical Injuries and Unspecified Complication of Corneal Transplant, run by Joseph B. Ciolino, MD at 1 site in United States.

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 9 inclusion and 8 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 21 Oct 2019. 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 United States. 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 combined 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.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Jul 2017). 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?

Changes in Corneal Thickness at 1 Millimeter (time frame: measured at week 4, 6, 26, 32, 52). The study lists 2 primary outcomes in all. 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 NCT01582880.

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 21 Oct 2019.