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

Sponsor

Instituto Universitario de Oftalmobiología Aplicada (Institute of Applied Ophthalmobiology) - IOBA (Other)

Overall Status

Completed

CT.gov ID

NCT00970957

Collaborator

(none)

107

Enrollment

Locations

Arms

Duration (Months)

8.2

Patients Per Site

0.2

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Macular Edema Retinal Vein Occlusion	Drug: Avastin Intravitreal Injection Drug: Sham Avastin Intravitreal Injection	Phase 3

Study Design

Study Type:

Interventional

Actual Enrollment :

107 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Double (Participant, 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

Study Start Date :

Sep 1, 2009

Actual Primary Completion Date :

Feb 1, 2013

Actual Study Completion Date :

Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
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 Names: 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 Names: 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 Names: 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 Names: Sham

Outcome Measures

Primary Outcome Measures

Best corrected visual acuity assessed as described in the Early Treatment for Diabetes Retinopathy Study (ETDRS) [1 month]

Secondary Outcome Measures

Macular Subcentral Field Thickness assessed by Ocular coherence tomography [1 month]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	Hospital Provincial Conxo - Fundación IDICHUS	Santiago de Compostela	La Coruña	Spain	15706
2	Hospital General Reina Sofía	Espinardo	Murcia	Spain	30100
3	Clínica Universitaria de Navarra	Pamplona	Navarra	Spain	31080
4	Instituto Oftalmológico de Alicante	Alicante		Spain	03015
5	Hospital de la Vall D´Hebrón	Barcelona		Spain	08022
6	Hospital Clinic	Barcelona		Spain	08036
7	Hospital Clínico San Carlos	Madrid		Spain	28010
8	Hospital Ramón y Cajal	Madrid		Spain	28034
9	Hospital La Paz	Madrid		Spain	28046
10	Hospital Virgen de la Macarena	Sevilla		Spain	41009
11	Hospital Virgen de Valme	Sevilla		Spain	41014
12	Hospital General Universitario de Valencia	Valencia		Spain	46014
13	Instituto Universitario de Oftalmobiología Aplicada	Valladolid		Spain	47011