Safety and Effectiveness of Bevacizumab Intravitreal Injections in the Treatment of Macular Edema Secondary to Retinal Vein Occlusion (EBOVER)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier:
NCT00970957
First received: September 2, 2009
Last updated: March 18, 2014
Last verified: March 2014
  Purpose

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.


Condition Intervention Phase
Macular Edema
Retinal Vein Occlusion
Drug: Avastin Intravitreal Injection
Drug: Sham Avastin Intravitreal Injection
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Study of the Safety and Efficacy of Bevacizumab Intravitreal Injections for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions

Resource links provided by NLM:


Further study details as provided by Instituto Universitario de Oftalmobiología Aplicada:

Primary Outcome Measures:
  • Best corrected visual acuity assessed as described in the Early Treatment for Diabetes Retinopathy Study (ETDRS) [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Macular Subcentral Field Thickness assessed by Ocular coherence tomography [ Time Frame: 1 month ] [ Designated as safety issue: No ]

Enrollment: 107
Study Start Date: September 2009
Study Completion Date: February 2013
Primary Completion Date: February 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Central RVO - Macular edema - Avastin
Patients 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.
Drug: Avastin Intravitreal Injection
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
Other Name: Avastin
Sham Comparator: Central RVO - Macular edema - Sham
Patients with Macular edema secondary to CENTRAL Retinal Vein Occlusion that will have a sham procedure performed. Injection without needle.
Drug: Sham Avastin Intravitreal Injection
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, ...).
Other Name: Sham
Experimental: Branch RVO - Macular edema - Avastin
Patients 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.
Drug: Avastin Intravitreal Injection
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
Other Name: Avastin
Sham Comparator: Branch RVO - Macular edema - Sham
Patients with Macular edema secondary to BRANCH Retinal Vein Occlusion that will have a sham procedure performed. Injection without needle.
Drug: Sham Avastin Intravitreal Injection
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, ...).
Other Name: Sham

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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).
  • Medical history of brain vascular episodes (stroke), ictus, angor pectoris or myocardial infarct within 3 months before study inclusion.
  • 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.
  • Medically uncontrolled intraocular pressure higher than 25 mm Hg.
  • External ocular illnesses active at inclusion as: conjunctivitis, blepharitis, eye sore, ...
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00970957

Locations
Spain
Hospital Provincial Conxo - Fundación IDICHUS
Santiago de Compostela, La Coruña, Spain, 15706
Hospital General Reina Sofía
Espinardo, Murcia, Spain, 30100
Clínica Universitaria de Navarra
Pamplona, Navarra, Spain, 31080
Instituto Oftalmológico de Alicante
Alicante, Spain, 03015
Hospital de la Vall D´Hebrón
Barcelona, Spain, 08022
Hospital Clinic
Barcelona, Spain, 08036
Hospital Ramón y Cajal
Madrid, Spain, 28034
Hospital Clínico San Carlos
Madrid, Spain, 28010
Hospital La Paz
Madrid, Spain, 28046
Hospital Virgen de Valme
Sevilla, Spain, 41014
Hospital Virgen de la Macarena
Sevilla, Spain, 41009
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Instituto Universitario de Oftalmobiología Aplicada
Valladolid, Spain, 47011
Sponsors and Collaborators
Instituto Universitario de Oftalmobiología Aplicada
Investigators
Principal Investigator: María Isabel López Gálvez, MD, PhD IOBA - Instituto Universitario de Oftalmobiología Aplicada
  More Information

No publications provided

Responsible Party: Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov Identifier: NCT00970957     History of Changes
Other Study ID Numbers: IOBA-03-2008, EUDRA -CT 2008-005789-30
Study First Received: September 2, 2009
Last Updated: March 18, 2014
Health Authority: Spain: Spanish Agency of Medicines

Keywords provided by Instituto Universitario de Oftalmobiología Aplicada:
Macular edema
Retinal Vein Occlusion
Bevacizumab

Additional relevant MeSH terms:
Edema
Macular Edema
Retinal Vein Occlusion
Signs and Symptoms
Macular Degeneration
Retinal Degeneration
Retinal Diseases
Eye Diseases
Venous Thrombosis
Thrombosis
Embolism and Thrombosis
Vascular Diseases
Cardiovascular Diseases
Bevacizumab
Angiogenesis Inhibitors
Angiogenesis Modulating Agents
Growth Substances
Physiological Effects of Drugs
Pharmacologic Actions
Growth Inhibitors
Antineoplastic Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on September 14, 2014