Estudio de fase 2 de microdosis de ranibizumab en el edema macular diabético - Estudio MINIMA 2

Criterios de inclusión

• Male or female subjects, 18 years of age or older
• Subjects with diagnosis of diabetes mellitus (Type I or II)
• Signed informed consent
• Patient must be able to comply with study assessments
• Clinical sings and angiographic evidence of diabetic macular edema
• Central foveal thickness of at least 270 assessed by OCT
• Best corrected visual acuity of 20/40 to 20/320 (ETDRS chart) in the study eye
• Use of any intraocular or periocular drug injection over the previous 3 months
• Macular or panretinal photocoagulation within 3 months of the study entry in the study eye
• High myopia (more than 6D)
• Any ocular disorders in the study eye that may confound interpretation of study results including patients with choroidal neovascularization, macular hole, retinal detachment, epiretinal membrane, ischemic maculopathy or any other retinal vascular disease such as vascular occlusive diseases.
• Vitreomacular traction
• Subretinal fibrosis
• Uncontrolled or advanced glaucoma
• Active ocular inflammation or history of active intraocular inflammation during the 6 months prior to enrollment of the study
• Any ophthalmic surgery performed within 3 months prior to study entry in the study eye
• Previous pars plana vitrectomy in the study eye
• History of ocular trauma of any type in the study eye
• Subjects with media opacities or abnormalities that would preclude observation of the retina in the study eye, per the investigator's judgement
• History of fluorescein allergy
• Known hypersensitivity to ranibizumab
• History of stroke or Myocardial infraction within 6 months
• Pregnancy, lactation or any women with no adequate contraception
• Participation in another simultaneous medical investigation or trial
• Any other condition that, in the opinion of the investigator, would produce a significant hazard or jeopardize the safety of the patient