- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01501760
Efficacy and Safety Study of Avastin to Treat Neovascularisation of the Cornea (BECONNEC)
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
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Limoges, France, 87042
- Service d'Ophtalmologie
-
Poitiers, France, 86021
- CHU Poitiers-Ophtalmologie
-
Saint-Étienne, France
- CHU ST Etienne
-
Strasbourg, France, 67000
- CHU Strasbourg- Service Ophtalmlogie
-
Toulouse, France, 31059
- CHU de Toulouse, Service d'Ophtalmologie
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
inclusion criteria:
- 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
Exclusion Criteria:
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
- 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)
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: bevacizumab
Three subconjunctival injections of 0.5 ml of bevacizumab at inclusion, 1 month, 2 month.
|
Three subconjunctival injections of 0.5 ml of bevacizumab at: inclusion, 1 month, 2 month
|
Placebo Comparator: Placebo
Three subconjunctival injections of 0.5 ml of Nacl at inclusion, 1 month, 2 month.
|
Three subconjunctival injections 0.5 ml placebo (Balanced salt) solution at inclusion, 1 month, 2month
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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.
|
at 3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Local and general toxicity of bevacizumab
Time Frame: at 1 months, 2 month, 3 month, 6 month
|
Safty data are collected at each visit either by clinical examination or by patient questionnary
|
at 1 months, 2 month, 3 month, 6 month
|
Efficacy at 6 months
Time Frame: at 6 month
|
Assessed using color photographs and a picture-analyser software that will calculate the percentage of corneal surface occupied by the newvessels at 6 month
|
at 6 month
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- I07034
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Corneal Newvessels
-
Keratoplasty Alliance InternationalRecruitingCorneal Disease | Corneal Transplant Failure | Endothelial Corneal Dystrophy | Corneal Transplant RejectionUnited States
-
Oregon Health and Science UniversityNational Eye Institute (NEI); National Institutes of Health (NIH)Completed
-
Umeå UniversityGlaukos CorporationActive, not recruitingEye Diseases | Keratoconus | Corneal Crosslinking | Corneal Densitometry | Scheimpflug Photography | Corneal DisorderSweden
-
Umeå UniversityGlaukos CorporationCompletedEye Diseases | Keratoconus | Corneal Disease | Corneal Crosslinking | Corneal Biomechanics | Corneal Densitometry | Scheimpflug PhotographySweden
-
University of California, IrvineWithdrawnCORNEAL OPACITY WITH POOR PROGNOSIS FOR CORNEAL TRANSPLANTUnited States
-
Cornea and Laser Eye InstituteActive, not recruitingKeratoconus | Corneal Ectasia | Irregular Astigmatism | Aberration, Corneal Wavefront | Wavefront Aberration, Corneal | Pellucid Marginal Corneal Degeneration | KeratoglobusUnited States
-
Klinikum Chemnitz gGmbHTechnische Universität DresdenCompletedCorneal Ulcers | Corneal MeltingGermany
-
University Hospital, Strasbourg, FranceTerminatedKeratitis | Pterygium | Corneal Perforation | Corneal Opacity Corneal ThinningFrance
-
Tianjin Eye HospitalRecruitingDeep Learning, Corneal Disease, ScreeningChina
-
University of Texas Southwestern Medical CenterCompletedCorneal Edema Secondary to Corneal Endothelial DystrophyUnited States
Clinical Trials on bevacizumab
-
National Cancer Institute (NCI)Active, not recruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Clear Cell Cystadenocarcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Serous Cystadenocarcinoma | Endometrial Clear Cell Adenocarcinoma | Endometrial Serous Adenocarcinoma | Recurrent... and other conditionsUnited States
-
National Cancer Institute (NCI)NRG OncologyCompletedGlioblastoma | Gliosarcoma | Recurrent Glioblastoma | Oligodendroglioma | Giant Cell Glioblastoma | Recurrent Brain NeoplasmUnited States, Canada
-
M.D. Anderson Cancer CenterRecruitingStage IB Hepatocellular Carcinoma AJCC v8 | Stage II Hepatocellular Carcinoma AJCC v8 | Resectable Hepatocellular Carcinoma | Stage I Hepatocellular Carcinoma AJCC v8 | Stage IA Hepatocellular Carcinoma AJCC v8United States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI)RecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Ovarian Endometrioid Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Fallopian Tube Clear Cell Adenocarcinoma | Fallopian Tube Endometrioid Adenocarcinoma | Fallopian Tube Serous Adenocarcinoma and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingOvarian Endometrioid Adenocarcinoma | Primary Peritoneal High Grade Serous Adenocarcinoma | Fallopian Tube Endometrioid Adenocarcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Ovarian High Grade Serous Adenocarcinoma | Platinum-Resistant... and other conditionsUnited States, Canada
-
National Cancer Institute (NCI)CompletedCervical Adenocarcinoma | Cervical Adenosquamous Carcinoma | Cervical Squamous Cell Carcinoma, Not Otherwise Specified | Stage IVA Cervical Cancer AJCC v6 and v7 | Recurrent Cervical Carcinoma | Stage IV Cervical Cancer AJCC v6 and v7 | Stage IVB Cervical Cancer AJCC v6 and v7United States
-
Northwestern UniversityNational Cancer Institute (NCI); Ipsen BiopharmaceuticalsCompletedRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Platinum-Resistant Fallopian Tube Carcinoma | Platinum-Resistant Primary Peritoneal Carcinoma | Platinum-Resistant Ovarian Carcinoma | Refractory Ovarian Carcinoma | Refractory Fallopian Tube... and other conditionsUnited States
-
Roswell Park Cancer InstituteNational Cancer Institute (NCI); Merck Sharp & Dohme LLC; Celldex TherapeuticsRecruitingRecurrent Fallopian Tube Carcinoma | Recurrent Ovarian Carcinoma | Recurrent Primary Peritoneal Carcinoma | Recurrent Endometrial Serous Adenocarcinoma | Ovarian Clear Cell Adenocarcinoma | Recurrent Platinum-Resistant Ovarian Carcinoma | Platinum-Sensitive Ovarian Carcinoma | Recurrent Fallopian... and other conditionsUnited States
-
National Cancer Institute (NCI)Active, not recruitingStage IV Cutaneous Melanoma AJCC v6 and v7 | Stage IIIC Cutaneous Melanoma AJCC v7 | Unresectable MelanomaUnited States
-
City of Hope Medical CenterNational Cancer Institute (NCI)Active, not recruitingMetastatic Lung Non-Small Cell Carcinoma | Stage IVA Lung Cancer AJCC v8 | Stage IVB Lung Cancer AJCC v8 | Stage III Lung Cancer AJCC v8 | Stage IV Lung Cancer AJCC v8 | Stage IIIA Lung Cancer AJCC v8 | Stage IIIB Lung Cancer AJCC v8 | Stage IIIC Lung Cancer AJCC v8 | Locally Advanced Lung Non-Small... and other conditionsUnited States