Resumen

The objective of this study is to investigate if the drug ranibizumab administrated by microdose injection into the eye is safe and effective to treat diabetic macular edema.

Descripción detallada

The MINIMA-2 Study is a multi-center clinical trial that initiated in order to investigate the effect of microdoses of ranibizumab in diabetic macular edema. The duration of the study is up to 13 months. Patients with diabetic macular edema will be randomized into 2 different groups. Consented subjects will receive monthly injections over a 6-month treatment period, and a 6 month follow-up and treatment period. Several eye examinations and procedures will be performed to evaluate response to the treatment. These include best corrected visual acuity testing (ETDRS), contrast sensitivity testing, ophthalmic examination, fluorescein angiography (FA)and macular thickness measurements based on optical coherence tomography (OCT). Serum chemistry, hematology and glycosylated hemoglobin HbA1c testing, urinalysis and pregnancy testing will be performed at screening visit (Days -14 to 0) and two more times during the study. Approximately 72 patients with a baseline central foveal thickness by OCT of at least 270 will be included. The BCVA must be worst than 20/40 but better than or equal to 20/320 due diabetic macular edema.

Elegibilidad

Edad mínima: 18 YearsEdad máxima: 75 YearsSexo: ALL

Criterios de inclusión

High myopia (more than 6D)
Uncontrolled or advanced glaucoma
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
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
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

Intervenciones

drug

Ranibizumab 0.05mg

Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria)

drug

Ranibizumab 0.5mg

Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)

Phase 2 Study of Microdoses of Ranibizumab in Diabetic Macular Edema - the MINIMA 2 Study