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

Macular Edema Clinical Trial

— EBOVER  

Official title:

Study of the Safety and Efficacy of Bevacizumab Intravitreal Injections for the Treatment of Macular Edema Secondary to Retinal Vein Occlusions

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00970957
• Other study ID #: IOBA-03-2008
• Secondary ID: EUDRA -CT 2008-0
• Status: Completed
• Phase: Phase 3
• First received: September 2, 2009
• Last updated: March 18, 2014
• Start date: September 2009
• Est. completion date: February 2013

Study information

• Verified date: March 2014
• Source: Instituto Universitario de Oftalmobiología Aplicada
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 107
• Est. completion date: February 2013
• Est. primary completion date: February 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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, ...

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Edema
• Macular Edema
• Retinal Vein Occlusion

Intervention

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
• 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, ...).

Locations

Country	Name	City	State
Spain	Instituto Oftalmológico de Alicante	Alicante
Spain	Hospital Clinic	Barcelona
Spain	Hospital de la Vall D´Hebrón	Barcelona
Spain	Hospital General Reina Sofía	Espinardo	Murcia
Spain	Hospital Clínico San Carlos	Madrid
Spain	Hospital La Paz	Madrid
Spain	Hospital Ramón y Cajal	Madrid
Spain	Clínica Universitaria de Navarra	Pamplona	Navarra
Spain	Hospital Provincial Conxo - Fundación IDICHUS	Santiago de Compostela	La Coruña
Spain	Hospital Virgen de la Macarena	Sevilla
Spain	Hospital Virgen de Valme	Sevilla
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Instituto Universitario de Oftalmobiología Aplicada	Valladolid

Sponsors (1)

Lead Sponsor	Collaborator
Instituto Universitario de Oftalmobiología Aplicada

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Best corrected visual acuity assessed as described in the Early Treatment for Diabetes Retinopathy Study (ETDRS)		1 month	No
Secondary	Macular Subcentral Field Thickness assessed by Ocular coherence tomography		1 month	No