Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion
EBOVER
Study of the Safety and Efficacy of Bevacizumab Intravitreal Injections for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions
2 other identifiers
interventional
107
1 country
13
Brief Summary
Lack of an effective treatment for macular edema secondary to central retinal vein occlusion and the bad response to grid laser treatment in patients with macular edema secondary to branch retinal vein occlusion, together with the high incidence of the pathology and the great functional loss in the patients that suffer from it has motivated the search for new therapeutic approaches. In recent times, intravitreal bevacizumab has been tested in clinical practice in small series of patients with this pathology, whether as first treatment or after failure of grid laser treatment with good functional results in short series. However, no retreatment information is available, although preliminary results from published series are good.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Sep 2009
Typical duration for phase_3
13 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
September 2, 2009
CompletedFirst Posted
Study publicly available on registry
September 3, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2013
CompletedMarch 19, 2014
March 1, 2014
3.4 years
September 2, 2009
March 18, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Best corrected visual acuity assessed as described in the Early Treatment for Diabetes Retinopathy Study (ETDRS)
1 month
Secondary Outcomes (1)
Macular Subcentral Field Thickness assessed by Ocular coherence tomography
1 month
Study Arms (4)
Central RVO - Macular edema - Avastin
EXPERIMENTALPatients with Macular edema secondary to CENTRAL Retinal Vein Occlusion that will be treated with intravitreal injection of avastin once per month during the first 3 months. Re-treatments will be given as per protocol.
Central RVO - Macular edema - Sham
SHAM COMPARATORPatients with Macular edema secondary to CENTRAL Retinal Vein Occlusion that will have a sham procedure performed. Injection without needle.
Branch RVO - Macular edema - Avastin
EXPERIMENTALPatients with Macular edema secondary to BRANCH Retinal Vein Occlusion that will be treated with intravitreal injection of avastin once per month during the first 3 months. Re-treatments will be given as per protocol.
Branch RVO - Macular edema - Sham
SHAM COMPARATORPatients with Macular edema secondary to BRANCH Retinal Vein Occlusion that will have a sham procedure performed. Injection without needle.
Interventions
Intravitreal injection of 1.25mg Avastin (Bevacizumab) per month, during the first 3 months. Retreatments will be required if visual acuity or macular edema thickness worsen as defined per protocol
Intravitreal Injection simulation with a syringe without needle. The rest of the procedure remains the same as if intravitreal injection were to be performed (antibiotic prophylaxis, local anesthesia, ...).
Eligibility Criteria
You may qualify if:
- Patient male or female 18 years old or more
- Foveal macular edema secondary to Retinal Vein Occlusion confirmed by Fluorescein angiography and Optical Coherence Tomography, with a subcentral field thickness of at least 250 microns
- Patients with best corrected visual acuity loss within the last 6 months of evolution, caused by the macular edema as stated by investigator´s judgement.
- Best corrected visual acuity tested by ETDRS within 20/40 and 20/400 in the study eye.
- Signed Informed consent.
- Signed Data Protection Consent.
- Negative pregnancy test before entering the study for childbearing potential women, who must commit to use a medically accepted contraceptive method for the whole study.
- Macular Subcentral field assessed by Ocular coherence tomography of at least 250 microns thick.
- No presence of eye opacities that may prevent fundus exploration. No condition that may prevent correct eye dilation.
- No known allergy to fluorescein.
- Only an eye per patient will be included in the study,even if both eyes have the pathology.
You may not qualify if:
- Macular edema secondary to any other condition such as: diabetes retinopathy, hypertension, Juxtafoveal telangiectasia, ...
- Any previous treatment for macular edema such as photocoagulation, vitrectomy, triamcinolone, radial optic neurotomy, ... in the study eye.
- Any ocular illness thay may be associated to increased/high levels of VEGF (Age related macular degeneration, Diabetes retinopathy, Uveitis, ...)
- Systemical illnesses thay may be associated to increased/high levels of VEGF (e.g. tumours).
- Pregnancy or nursing.
- Hypersensibility known or suspected to Bevacizumab, his excipients or any related molecule.
- Uncontrolled hypertension refractary to medical treatment.
- Participation in any other trial or study within the last 3 months (minerals and vitamins excluded) or treatment with anti-VEGF in the non-study eye within the previous 3 months.
- Tractional maculopathy and/or epiretinal membrane assessed by Ocular Coherence Tomography.
- Media opacities that don´t allow correct eye exploration and fundus examination/photographs.
- Cataract surgery / Yag capsulotomy within the previous 6 months.
- Filtration surgery.
- Previous medical history of ocular illnesses as: viral infections, inflammatory pathology, serous central choroidopathy, retinal detachment or any other illness that may have an influence in visual acuity.
- Presence of foveal atrophy, severe pigmentary changes, dense subfoveal haemorrhages, confluent subfoveal hard exudates or any other condition that may influence functional recovery of the macular edema.
- Cataract that may be responsible for additional visual acuity loss of more than 2/10.
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (13)
Instituto Oftalmológico de Alicante
Alicante, Alicante, 03015, Spain
Hospital de la Vall D´Hebrón
Barcelona, Barcelona, 08022, Spain
Hospital Clinic
Barcelona, Barcelona, 08036, Spain
Hospital Provincial Conxo - Fundación IDICHUS
Santiago de Compostela, La Coruña, 15706, Spain
Hospital Clínico San Carlos
Madrid, Madrid, 28010, Spain
Hospital Ramón y Cajal
Madrid, Madrid, 28034, Spain
Hospital La Paz
Madrid, Madrid, 28046, Spain
Hospital General Reina Sofía
Espinardo, Murcia, 30100, Spain
Clínica Universitaria de Navarra
Pamplona, Navarre, 31080, Spain
Hospital Virgen de la Macarena
Seville, Sevilla, 41009, Spain
Hospital Virgen de Valme
Seville, Sevilla, 41014, Spain
Hospital General Universitario de Valencia
Valencia, Valencia, 46014, Spain
Instituto Universitario de Oftalmobiología Aplicada
Valladolid, Valladolid, 47011, Spain
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
María Isabel López Gálvez, MD, PhD
IOBA - Instituto Universitario de Oftalmobiología Aplicada
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 2, 2009
First Posted
September 3, 2009
Study Start
September 1, 2009
Primary Completion
February 1, 2013
Study Completion
February 1, 2013
Last Updated
March 19, 2014
Record last verified: 2014-03