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Intravitreal ranibizumab combined with green diode laser (ETDRS) or pattern scan laser (Pascal) panretinal photocoagulation (PRP) combined with intravitreal ranibizumab (IVR) versus only intravitreal ranibizumab for proliferative diabetic retinophaty

Grant number: 12/17309-1
Support type:Regular Research Grants
Duration: March 01, 2013 - February 28, 2015
Field of knowledge:Health Sciences - Medicine
Principal Investigator:Rodrigo Jorge
Grantee:Rodrigo Jorge
Home Institution: Faculdade de Medicina de Ribeirão Preto (FMRP). Universidade de São Paulo (USP). Ribeirão Preto , SP, Brazil

Abstract

Introduction: The DRS and ETDRS showed the benefits of preventing losses of vision acuity and new vessels' progress in high risk proliferative diabetic retinophaty by panretinal laser photocoagulation (PRP). However, the PRP parameters have been related to extensive damages in retina's function and morphology as perimetry's contraction, worsening macular' aedema and sometimes being painful for patients. According to this settings, new therapies as intravitreal antiVEGF (Ranibizumab or Bevacizumab) and pattern scan laser (Pascal) have been included in order to optimize desease's control, decreasing retinal damage and improving patient's adherence.Objectives: To evaluate the retinal effects of panretinal laser photocoagulaton with single spot (ETDRS-PRP) comparing with panretinal laser photocoagulaton with multiple spot (PASCAL-PRP) associated to intravitreal Ranibizumab (IVR), by changes in total area of new vessels activity, visual acuity, retinal electral physiology and visual perimetry. Methods: Prospective and randomized clinical trial with 45 patients with hPDR divided into 3 groups according to the treatment: ETDRS + IVR (n=15), PASCAL + IVR (n=15) and IVR (n=15). Evaluations will include measurement of best-corrected visual acuity, ISCEV-Standard full-field electroretinogram (ERG), full-field scotopic threshold, visual field (30-2-threshold), retinography and fluorescein angiography, and optical coherence tomography (OCT). Exams will be performed at baseline, 4, 8 and 12 weeks after treatment.Expected results: We expect to describe the changes in retinal function and morphology associated with the different treatment strategies, and to estimate their relationships with therapeutic efficiency. (AU)