WithdrawnPhase 4

Unilateral Bevacizumab for Bilateral Diabetic Macular Edema

Stopped: Poor accrual

Mexico0Started 2007-04

Plain-language summary

The endothelial growth factor (VEGF), has been implied in the genesis of diverse Neovascular disease. In the industrialized and developing countries, the main cause of blindness is the diabetic retinopathy. Bevacizumab (Avastin, genentech, Inc., San Francisco, California, the USA) is a drug.In the last years its use "off-label", in ophthalmology field, has become popular. This is due to its proven safeness and effectiveness for the treatment of diverse ocular diseases. A lot has been speculated about the systemic absorption of Bevacizumab. It is for that reason that the objective of this study is the systematic and random revision of the fellows eyes, of the patients programmed for the intravitreal administration of Bevacizumab, with bilateral macular edema. In such a way that the therapeutic value in the fellow eye of bevacizumab can be determined

Who can participate

Age range30 Years – 90 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Patient greater of 30 years old, with bilateral diffuse diabetic macular edema, with any degree of diabetic retinopathy that has been programmed for Bevacizumab intravitreal administration in one of both eyes. * Bilateral macular Thickening, measured by OCT of 225mm or bigger. * Pupil dilatation greater than 5mm. * Patient with no previous treatment for diabetic macular edema. Exclusion Criteria: * Focal diabetic macular edema or macular edema of different etiology, besides diabetes. (uveitis, pseudophakic patients, vitreous-retinal traction, CRVO, BRVO, CSC). * Macular edema 3B patter, measured by OCT, according to the macular edema classification. * Medical history of severe thromboembolic events, uncontrolled arterial hypertension, transitory ischemic attacks, cardiac stroke, acute cerebral vascular event. * Pregnant women or breast feeding women * Know allergy to Bevacizumab

What they're measuring

Retinal thickness

Timeframe: Interventional

Trial details

NCT IDNCT00496405

SponsorAsociación para Evitar la Ceguera en México

Sponsor typeOTHER

Study typeINTERVENTIONAL