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Clinical Trial Summary

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.


Clinical Trial Description

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 Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment


Related Conditions & MeSH terms


NCT number NCT01112085
Study type Interventional
Source Especialistas en Retina Medica y Quirurgica Grupo de Investigacion
Contact
Status Completed
Phase Phase 2
Start date April 2010
Completion date June 2014

See also
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