| Grant number: | 09/08895-1 |
| Support Opportunities: | Regular Research Grants |
| Start date: | November 01, 2010 |
| End date: | October 31, 2012 |
| Field of knowledge: | Health Sciences - Medicine |
| Principal Investigator: | Walter Yukihiko Takahashi |
| Grantee: | Walter Yukihiko Takahashi |
| Host Institution: | Faculdade de Medicina (FM). Universidade de São Paulo (USP). São Paulo , SP, Brazil |
| City of the host institution: | São Paulo |
Abstract
Nowadays Brazil has approximately 5 million diabetic patients and it is estimated 11 million in 2025. The direct and indirect costs with the disease represent 5 to 14% of the economic sources Brazilian public health system. United States spends 138 billion dollars per year with diabetes mellitus (DM). One of the most important complication of DM is diabetic retinopathy (DR). It is the main cause of blindness in Americans between 20-64 years of age, causing 8000 new cases of blindness per year. In Brazil it is estimated that half of patients with DM are affected by DR, been responsible for 7,5% of the causes of laboral incapacity in adults. It is emphasized the importance of studies related to DR, to minimize the limitations caused by this disease. The purpose of this prospective, randomized and comparative study is to quantify the functional and structural alterations of the macula in patients with proliferative DR submitted to laser photocoagulation and to evaluate the efficacy of intravitreal bevacizumab as a adjuvant therapy in preventing the adverse events of that procedure. The study will be conducted in patients assisted at Clínica Oftalmológica of the HC-FMUSP. The patients with proliferative DR with indication of binocular laser photocoagulation will be examined by ophthalmologists who will measure the visual acuity, perform slit lamp examination, fundus examination, optic coherence tomography and eletroretinography before and after laser photocoagulation. Laser photocoagulation will be performed in both eyes according the multicentric study called "Early Treatment Diabetic Retinopathy Study" that advocate the realization of 3 episodes of laser photocoagulation in 3 weeks.This comparative study analyses the effect of intravitreal bevacizumab one week before laser photocoagulation and one month after the randomization visit. The fellow eye will be submitted only to laser photocoagulation and will be considered as control. It is estimated a sample of 30 patients. All procedures, purposes and methods will be explained to all patients. (AU)
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