Corneal NewvesselsPhase 3BECONNECNCT01501760
Efficacy and Safety Study of Avastin to Treat Neovascularisation of the Cornea
A Phase 3 study testing bevacizumab and NaCl in people with Corneal Newvessels, run by University Hospital, Limoges at 5 sites in France.
Trial summary
Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed to reduce newascularization induced by gastric cancer or age-related macular degeneration. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Corneal Newvessels
- What is being tested?
- bevacizumab and NaCl
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 38 participants
- Where
- 5 sitesFrance
- Study dates
- 13 May 2012to Oct 2019
- Phase
- Phase 3
- 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
- Patients with corneal neovascularization whatever the origin
- Patient did not receive treatment with topical corticosteroids during the month preceding inclusion.
- Patient who has been properly informed and signed consent
- Patient aged over 18
- Patient affiliated with a health insurance plan or benefit of such a regime
Who cannot join
- Patients who received local or general treatment of concomitant prostaglandin derivatives
- Patients with current infection of the cornea or other tissue / organ
- Women of childbearing age without contraception
- Pregnancy and Lactation
- Patient participating in another study
- Patient with contact lenses
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- Patients with uncontrolled hypertension
- Patient with a history of stroke, myocardial infarction, angina pectoris, thrombophlebitis, Raynaud's phenomenon.
- Patients hypersensitive to the active substance or any excipients
- Patients hypersensitive to products of Chinese hamster ovary cells or other recombinant human or humanized antibodies.
- Patients with active bacterial eye infections, fungal, parasitic or viral infection (with the exception of herpes)
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Service d'Ophtalmologie
Limoges, 87042
CHU Poitiers-Ophtalmologie
Poitiers, 86021
CHU St Etienne
Saint-Etienne
CHU Strasbourg- Service Ophtalmlogie
Strasbourg, 67000
CHU de Toulouse, Service d'Ophtalmologie
Toulouse, 31059
About this study
Official title: Effect of Bevacizumab Subconjunctival Injections on Corneal Newvessels
Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed to reduce newascularization induced by gastric cancer or age-related macular degeneration. A few reports have been published showing the interest of VEGF inhibitors to treat corneal newvessels, but no randomized study has been achieved to date.
This study is designed to assess the efficacy of Bevacizumab, a VEGF inhibitor monoclonal antibody, to reduce the surface of corneal newvessels in when compared to placebo
Read the detailed description
This study will involve 42 outpatients of the CHU of Limoges, Bordeaux, and Toulouse, addressed for corneal pathologies including corneal newvessels. The patients will be randomly assigned to two groups, one receiving three subconjunctival injections of bevacizumab, the other three subconjunctival injections of placebo (Balanced salt solution). The progression of newvessels will be assessed using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels. Randomization, and preparation of both study drug and placebo syringes will be performed by the central pharmacy of the CHU de Limoges. Patients will be followed-up as outpatients, with visits scheduled 15 days before treatment, at baseline, and then at 1 month, 2 months, 3 months, and 6 months.
- Primary outcome: To demonstrate Bevacizumab subconjunctival injections effectiveness on corneal neovascularisation reduction definite by a superior percentage of patient with a reduction higher than 30 % of the corneal surface occupied by newvessels , at 3 months, in the group Bevacizumab compared with the group placebo
- Secondary outcomes:
- The effectiveness of bevacizumab on reducing the percentage of corneal surface occupied by neovascularization at 6 months
- The effectiveness of bevacizumab on reducing the use of corneal graft.
- The local and general toxicity of bevacizumab administered by subconjunctival way.
- Conditions
- Corneal Newvessels
- Being tested
- bevacizumab, NaCl
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
bevacizumabDrug
Three subconjunctival injections of 0.5 ml of bevacizumab at: inclusion, 1 month, 2 month
NaClDrug
Three subconjunctival injections 0.5 ml placebo (Balanced salt) solution at inclusion, 1 month, 2month
| Study group | Role | What they receive |
|---|---|---|
| bevacizumab | Experimental | Three subconjunctival injections of 0.5 ml of bevacizumab at inclusion, 1 month, 2 month. Receives: Drug: bevacizumab |
| Placebo | Placebo comparator | Three subconjunctival injections of 0.5 ml of Nacl at inclusion, 1 month, 2 month. Receives: Drug: NaCl |
What is being measured
The primary outcome is the main question the study is designed to answer.
Neovascularisation reduction at 3 months
Assessement using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 3 months. A reduction of 30% is target.
Measured: at 3 months
Secondary outcomes (2)
Local and general toxicity of bevacizumab
Safty data are collected at each visit either by clinical examination or by patient questionnary
Measured: at 1 months, 2 month, 3 month, 6 month
Efficacy at 6 months
Assessed using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 6 month
Measured: at 6 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Dec 2011 (estimated)
- Study start13 May 2012
- Primary completionOct 2019
- Study completionOct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Corneal NewvesselsStudies of the same condition, open and under way.
- More trials run by University Hospital, LimogesThe 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Limoges
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01501760
- Sponsor's protocol ID
- I07034
- Acronym
- BECONNEC
- Status last verified
- Oct 2018
- First submitted
- 26 Dec 2011
- Last updated
- 24 Oct 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Bevacizumab Subconjunctival Injections on Corneal Newvessels
- ClinicalTrials.gov ID
- NCT01501760
- Acronym / sponsor ID
- BECONNEC / I07034
- Conditions
- Corneal Newvessels
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University Hospital, LimogesUniversity, hospital or other
- Study start
- 13 May 2012 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Oct 2019 (actual)
- First posted
- 29 Dec 2011 (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.
Corneal newvessels may arise from a fan of pathologies, inducing long-standing corneal opacification requiring keratoplasty. These last years, VEGF inhibitors have been designed to reduce newascularization induced by gastric cancer or age-related macular degeneration. A few reports have been published showing the interest of VEGF inhibitors to treat corneal newvessels, but no randomized study has been achieved to date.
This study is designed to assess the efficacy of Bevacizumab, a VEGF inhibitor monoclonal antibody, to reduce the surface of corneal newvessels in when compared to placebo
Detailed description
This study will involve 42 outpatients of the CHU of Limoges, Bordeaux, and Toulouse, addressed for corneal pathologies including corneal newvessels. The patients will be randomly assigned to two groups, one receiving three subconjunctival injections of bevacizumab, the other three subconjunctival injections of placebo (Balanced salt solution). The progression of newvessels will be assessed using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels. Randomization, and preparation of both study drug and placebo syringes will be performed by the central pharmacy of the CHU de Limoges. Patients will be followed-up as outpatients, with visits scheduled 15 days before treatment, at baseline, and then at 1 month, 2 months, 3 months, and 6 months.
- Primary outcome: To demonstrate Bevacizumab subconjunctival injections effectiveness on corneal neovascularisation reduction definite by a superior percentage of patient with a reduction higher than 30 % of the corneal surface occupied by newvessels , at 3 months, in the group Bevacizumab compared with the group placebo
- Secondary outcomes:
- The effectiveness of bevacizumab on reducing the percentage of corneal surface occupied by neovascularization at 6 months
- The effectiveness of bevacizumab on reducing the use of corneal graft.
- The local and general toxicity of bevacizumab administered by subconjunctival way.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| bevacizumab | Experimental | Drug: bevacizumabThree subconjunctival injections of 0.5 ml of bevacizumab at inclusion, 1 month, 2 month. |
| Placebo | Placebo comparator | Drug: NaClThree subconjunctival injections of 0.5 ml of Nacl at inclusion, 1 month, 2 month. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patients with corneal neovascularization whatever the origin
- Patient did not receive treatment with topical corticosteroids during the month preceding inclusion.
- Patient who has been properly informed and signed consent
- Patient aged over 18
- Patient affiliated with a health insurance plan or benefit of such a regime
Key exclusion criteria (11 listed)
- Patients who received local or general treatment of concomitant prostaglandin derivatives
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 |
|---|---|---|
| bevacizumabThree subconjunctival injections of 0.5 ml of bevacizumab at: inclusion, 1 month, 2 month | Drug | bevacizumab |
| NaClThree subconjunctival injections 0.5 ml placebo (Balanced salt) solution at inclusion, 1 month, 2month | Drug | Placebo |
Primary outcome
Neovascularisation reduction at 3 months
Time frame: at 3 months
Assessement using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 3 months. A reduction of 30% is target.
2 secondary outcomes
Local and general toxicity of bevacizumab
Time frame: at 1 months, 2 month, 3 month, 6 month
Efficacy at 6 months
Time frame: at 6 month
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 24 Oct 2019.
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.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing bevacizumab and NaCl in people with Corneal Newvessels, run by University Hospital, Limoges at 5 sites in France.
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 11 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 24 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 5 sites in France. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Neovascularisation reduction at 3 months (time frame: at 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 24 Oct 2019.