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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
72
Intravitreal injections of 0.05mg ranibizumab over 6 months then additional treatment with ranibizumab 0.05mg as needed (according to re-treatment criteria)
Intravitreal injections of 0.5mg ranibizumab over 6 months then additional treatment with ranibizumab 0.5mg as needed (according to re-treatment criteria)
Centro Privado de Ojos Rogamosa SA y Fundación VER
Córdoba, Argentina
Hospital San José
Guadalajara, Jalisco, Mexico
Centro de Retina Médica y Quirúrgica S. C.
Zapopan, Jalisco, Mexico
Hospital Regional Valentín Gómez Farías
Zapopan, Jalisco, Mexico
Best corrected visual acuity
Improvement in vision of best corrected visual acuity of 15 or more letters, or a final vision of 20/25 (50 letters) or better if best corrected visual acuity (BCVA) was 20/40 (40 letters)
Time frame: 12 months
Mean change in central retinal thickness and volume by OCT
Changes in central retinal thickness and volume assessed by optical coherence tomography (OCT)
Time frame: 6 months and 12 months
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Hospital Universitario Doctor José Eleuterio González
Monterrey, Nuevo León, Mexico
Hospital Central
San Luis Potosí City, San Luis Potosí, Mexico