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 range

30 Years – 90 Years

Sex

ALL

See this in plain English?

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Retinal thickness

Timeframe: Interventional

Trial details

NCT IDNCT00496405

SponsorAsociación para Evitar la Ceguera en México

Sponsor typeOTHER

Study typeINTERVENTIONAL

View on ClinicalTrials.gov More Diabetic Macular Edema trials