Lipid KeratopathyNCT00681603
Safety and Effectiveness of Subconjunctival Injection of Bevacizumab in the Treatment of Corneal Neovasculization
A study testing subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg) in people with Lipid Keratopathy and Penetrating Keratoplasty, run by National Taiwan University Hospital at 1 site in Taiwan.
Trial summary
1. Purpose:Our animal study demonstrated the effectiveness of subconjunctival injection of bevacizumab in the inhibition of corneal neovasculization formation. The purpose of this human interventional study is to report the treatment outcome of subconjunctival injection of bevacizumab in patients with corneal… Read more about this study
- Who is it for?
- Ages 10 to 70 years
- Conditions the study is for
- Lipid Keratopathy, Penetrating Keratoplasty, Herpetic Keratopathy
- What is being tested?
- subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 13 participants
- Where
- 1 siteTaiwan
- Study dates
- Aug 2007to Feb 2008
- Phase
- Interventional
- 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 10 to 70 years
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Significant unilateral or bilateral corneal neovascularization that extending over the limbus at least 2mm
- The underlying etiologies that caused corneal neovascularization included post penetrating keratoplasty (PKP), trauma, infectious or non-infectious corneal ulcer, post-keratoplasty, etc.
- Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25
- Post-PKP corneal neovascularization that had no associated lipid keratopathy, no corneal edema, or corneal irregularity. But the neovascularization was highly possible to cause graft rejection.
- The corneal neovascularization was refractory to other medical treatment
- The patient had received PKP or other corneal surgeries more than half a year ago and was not in the acute post-operation phase
- The patient had no active endopthalmitis, glaucoma with uncontrolled intraocular pressure, or vitreoretinal diseases
- The patient signed inform consent to have regular follow up and treatment
Who cannot join
- The neovascularization had clinical improvement three months before the first injection
- The lipid keratopathy had clinical improvement three months before the first injection
- The patient that suspected to have poor visual outcome or had already been light sense negative
- Glaucoma patient that had uncontrolled intraocular pressure
- Poor corneal epithelialization
- Post-PKP patient that had graft failure or rejection
- Patient that had systemic disease which was not suitable for bevacizumab use
- Pregnant patient
Trial locations and contacts
1 site in 1 country.
Taiwan1 site
Department of Ophthalmology, National Taiwan University Hospital,
Taipei, Taipei, 100
About this study
Official title: The Application of Subconjunctival Injection of Bevacizumab (Avastin) in the Treatment of Corneal Neovasculization
- Purpose:Our animal study demonstrated the effectiveness of subconjunctival injection of bevacizumab in the inhibition of corneal neovasculization formation. The purpose of this human interventional study is to report the treatment outcome of subconjunctival injection of bevacizumab in patients with corneal neovascularization.
- Material and methods: We enrolled 13 patients with unilateral or bilateral clinically significant corneal neovascularization during Aug. 2007 to Jan. 2008. Subconjunctival injection of bevacizumab once per month for at most 7 times was performed according to clinical response.
- Main outcome measurements: resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity.
- Being tested
- subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)
- Keywords
- corneal neovascularization, lipid keratopathy, penetrating keratopathy, bevacizumab, Avastin, subconjunctival injection
- Medical subject headings
- Rosacea, Corneal Neovascularization
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)Drug
Also called bevacizumab ( Avastin )
subconjunctival injection of bevacizumab ( 1.25 to 2.50mg) according to the clinical judgment. Once per months for three times then reevaluate the drug effect, if the response was adequate, stop the trial; if no improvement, another three month intervention would be performed.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | 13 cases that accepted subconjunctival injection of bevacizumab Receives: Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity
Measured: prospective
Secondary outcomes (1)
major side effects
Measured: prospective
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2008 (estimated)
- Study startAug 2007
- Primary completionFeb 2008
- Study completionFeb 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lipid KeratopathyStudies of the same condition, open and under way.
- More trials run by National Taiwan University HospitalThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Taiwan University Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Wei-Li Chen, Principal investigator, National Taiwan University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00681603
- Sponsor's protocol ID
- 200708015M
- Status last verified
- Aug 2007
- First submitted
- 19 May 2008
- Last updated
- 21 May 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Application of Subconjunctival Injection of Bevacizumab (Avastin) in the Treatment of Corneal Neovasculization
- ClinicalTrials.gov ID
- NCT00681603
- Acronym / sponsor ID
- 200708015M
- Keywords
- corneal neovascularization, lipid keratopathy, penetrating keratopathy, bevacizumab, Avastin, subconjunctival injection
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- National Taiwan University HospitalUniversity, hospital or other
- Study start
- Aug 2007
- Primary completion
- Feb 2008 (actual)
- Study completion
- Feb 2008 (actual)
- First posted
- 21 May 2008 (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.
- Purpose:Our animal study demonstrated the effectiveness of subconjunctival injection of bevacizumab in the inhibition of corneal neovasculization formation. The purpose of this human interventional study is to report the treatment outcome of subconjunctival injection of bevacizumab in patients with corneal neovascularization.
- Material and methods: We enrolled 13 patients with unilateral or bilateral clinically significant corneal neovascularization during Aug. 2007 to Jan. 2008. Subconjunctival injection of bevacizumab once per month for at most 7 times was performed according to clinical response.
- Main outcome measurements: resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Drug: subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)13 cases that accepted subconjunctival injection of bevacizumab |
Who may qualify
- Ages
- 10 to 70 years
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Significant unilateral or bilateral corneal neovascularization that extending over the limbus at least 2mm
- The underlying etiologies that caused corneal neovascularization included post penetrating keratoplasty (PKP), trauma, infectious or non-infectious corneal ulcer, post-keratoplasty, etc.
- Corneal neovascularization induced lipid keratopathy, corneal edema, or irregular corneal surface. The best-corrected visual acuity was less than 20/25
- Post-PKP corneal neovascularization that had no associated lipid keratopathy, no corneal edema, or corneal irregularity. But the neovascularization was highly possible to cause graft rejection.
- The corneal neovascularization was refractory to other medical treatment
Key exclusion criteria (8 listed)
- The neovascularization had clinical improvement three months before the first injection
- The lipid keratopathy had clinical improvement three months before the first injection
- The patient that suspected to have poor visual outcome or had already been light sense negative
- Glaucoma patient that had uncontrolled intraocular pressure
- Poor corneal epithelialization
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 |
|---|---|---|
| subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg)Also: bevacizumab ( Avastin )subconjunctival injection of bevacizumab ( 1.25 to 2.50mg) according to the clinical judgment. Once per months for three times then reevaluate the drug effect, if the response was adequate, stop the trial; if no improvement, another three month intervention would be performed. | Drug | 1 |
Primary outcome
Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity
Time frame: prospective
1 secondary outcome
major side effects
Time frame: prospective
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 21 May 2008.
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.
Wei-Li Chen principal investigator
National Taiwan University Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing subconjunctival injection of bevacizumab ( 1.25 to 2.50 mg) in people with Lipid Keratopathy and Penetrating Keratoplasty, run by National Taiwan University Hospital at 1 site in Taiwan.
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 8 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 May 2008. 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 Taiwan. 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?
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?
Resolution of corneal neovascularization, reduction of lipid infiltrate, improved visual acuity (time frame: prospective). 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 21 May 2008.