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

Information source: Instituto Universitario de Oftalmobiología Aplicada
ClinicalTrials.gov processed this data on August 20, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Macular Edema; Retinal Vein Occlusion

Intervention: Avastin Intravitreal Injection (Drug); Sham Avastin Intravitreal Injection (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Instituto Universitario de Oftalmobiología Aplicada

Official(s) and/or principal investigator(s):
María Isabel López Gálvez, MD, PhD, Principal Investigator, Affiliation: IOBA - Instituto Universitario de Oftalmobiología Aplicada


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.

Clinical Details

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

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

Primary outcome: Best corrected visual acuity assessed as described in the Early Treatment for Diabetes Retinopathy Study (ETDRS)

Secondary outcome: Macular Subcentral Field Thickness assessed by Ocular coherence tomography


Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.


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


- 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.


- 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


- 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


- Media opacities that don´t allow correct eye exploration and fundus


- 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, ...

Locations and Contacts

Instituto OftalmolĂłgico de Alicante, Alicante 03015, Spain

Hospital Clinic, Barcelona 08036, Spain

Hospital de la Vall D´Hebrón, Barcelona 08022, Spain

Hospital ClĂ­nico San Carlos, Madrid 28010, Spain

Hospital La Paz, Madrid 28046, Spain

Hospital RamĂłn y Cajal, Madrid 28034, Spain

Hospital Virgen de la Macarena, Sevilla 41009, Spain

Hospital Virgen de Valme, Sevilla 41014, Spain

Hospital General Universitario de Valencia, Valencia 46014, Spain

Instituto Universitario de OftalmobiologĂ­a Aplicada, Valladolid 47011, Spain

Hospital Provincial Conxo - Fundación IDICHUS, Santiago de Compostela, La Coruña 15706, Spain

Hospital General Reina SofĂ­a, Espinardo, Murcia 30100, Spain

ClĂ­nica Universitaria de Navarra, Pamplona, Navarra 31080, Spain

Additional Information

Starting date: September 2009
Last updated: March 18, 2014

Page last updated: August 20, 2015

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