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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 investigatorĀ“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 donĀ“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


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
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