Progressive KeratoconusPhase 2CXLNCT00925327
Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus
A Phase 2 study testing Corneal collagen cross-linking with riboflavin/UVA light in people with Progressive Keratoconus, run by Peschke Meditrade, GmbH at 1 site in United States.
Trial summary
This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Progressive Keratoconus
- What is being tested?
- Corneal collagen cross-linking with riboflavin/UVA light
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- Start not givento not given
- Phase
- Phase 2
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age 6 to 18 years
- Having a diagnosis of progressive keratoconus
- Signed written informed consent
- Having a condition that limits the patient's capacity to comply with the cross-linking treatment procedures and/or the diagnostic tests and measurements required by the ongoing clinical studies
- Willingness and ability to comply with schedule for follow-up visits
Who cannot join
- Corneal pachymetry at the screening exam that is <400 microns at the thinnest point
- Previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications, for example (herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
- A history of delayed epithelial healing in the eye(s) to be treated
- Pregnancy or lactation during the course of the study
- A known sensitivity to study medications
Trial locations and contacts
1 site in 1 country.
Erin D. Stahl, MD contact
United States1 site
Children's Mercy Hospitals and Clinics
Kansas City, Missouri, 65108
Erin D. Stahl, MD, 816-234-3046
Scott E. Olitsky, MD
About this study
This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.
Read the detailed description
This is a non-randomized study. All eyes that qualify for the study will receive the cross-linking (CXL) procedure. Corneal collagen cross-linking is performed as a single treatment. Depending on the patient's condition, the CXL procedure may be performed under sedation or anesthesia. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.
- Conditions
- Progressive Keratoconus
- Being tested
- Corneal collagen cross-linking with riboflavin/UVA light
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Corneal collagen cross-linking with riboflavin/UVA lightOther
Corneal collagen cross-linking with riboflavin/UVA light
| Study group | Role | What they receive |
|---|---|---|
| Corneal collagen cross-linking with riboflavin and UVA light | Experimental | Not described Receives: Other: Corneal collagen cross-linking with riboflavin/UVA light |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in keratometry
Measured: 3 Months
Secondary outcomes (1)
Change in manifest refraction spherical equivalent
Measured: 3 Month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2009 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Progressive KeratoconusStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 7 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peschke Meditrade, GmbH
- Sponsor type
- Industry (pharma, biotech, devices)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00925327
- Sponsor's protocol ID
- UVX-004
- Acronym
- CXL
- Status last verified
- Jun 2009
- First submitted
- 19 Jun 2009
- Last updated
- 22 Jun 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety and Effectiveness of the UV-X System for Corneal Collagen Cross-Linking for Compassionate Treatment in Pediatric Patients With Progressive Keratoconus
- ClinicalTrials.gov ID
- NCT00925327
- Acronym / sponsor ID
- CXL / UVX-004
- Conditions
- Progressive Keratoconus
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 7 participants (estimated)
- Lead sponsor
- Peschke Meditrade, GmbHIndustry (pharma, biotech, devices)
- First posted
- 22 Jun 2009 (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.
This is a compassionate treatment protocol for the use of the UV-X system for corneal collagen cross-linking (CXL) in eyes with progressive keratoconus in patients who have conditions that limit their capacity to comply with the cross-linking treatment procedures required by ongoing clinical trials.
Detailed description
This is a non-randomized study. All eyes that qualify for the study will receive the cross-linking (CXL) procedure. Corneal collagen cross-linking is performed as a single treatment. Depending on the patient's condition, the CXL procedure may be performed under sedation or anesthesia. Subjects are followed for 12 months after the procedure to evaluate the long term effects of corneal collagen cross-linking.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Corneal collagen cross-linking with riboflavin and UVA light | Experimental | Other: Corneal collagen cross-linking with riboflavin/UVA light |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age 6 to 18 years
- Having a diagnosis of progressive keratoconus
- Signed written informed consent
- Having a condition that limits the patient's capacity to comply with the cross-linking treatment procedures and/or the diagnostic tests and measurements required by the ongoing clinical studies
- Willingness and ability to comply with schedule for follow-up visits
Key exclusion criteria (5 listed)
- Corneal pachymetry at the screening exam that is <400 microns at the thinnest point
- Previous ocular condition in the eye(s) to be treated that may predispose the eye for future complications, for example (herpes simplex, herpes zoster keratitis, recurrent erosion syndrome, corneal melt, or corneal dystrophy, etc.)
- A history of delayed epithelial healing in the eye(s) to be treated
- Pregnancy or lactation during the course of the study
- A known sensitivity to study medications
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 |
|---|---|---|
| Corneal collagen cross-linking with riboflavin/UVA lightCorneal collagen cross-linking with riboflavin/UVA light | Other | Corneal collagen cross-linking with riboflavin and UVA light |
Primary outcome
Change in keratometry
Time frame: 3 Months
1 secondary outcome
Change in manifest refraction spherical equivalent
Time frame: 3 Month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jun 2009.
Related trials for Progressive Keratoconus
RecruitingPhase 2/3
Corneal Crosslinking for Treatment of Progressive Keratoconus or Corneal Ectasia
Keratoconus, Corneal Ectasia
Enrolling by invitationPhase 1/2
Study of TN-001 Topical Eyedrops for Keratoconus
Keratoconus
RecruitingPhase 3
Use of a Freeze-dried Amniotic Membrane Post Crosslinking in Subjects With Progressive Keratoconus
Progressive Keratoconus
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.
Erin D. Stahl, MD contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Corneal collagen cross-linking with riboflavin/UVA light in people with Progressive Keratoconus, run by Peschke Meditrade, GmbH 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 5 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 22 Jun 2009. 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 phase mean?
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Erin D. Stahl, MD (816-234-3046), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in keratometry (time frame: 3 Months). 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 22 Jun 2009.