Diabetic Macular Edema Clinical Trial
Official title:
Phase 2 Study of Microdoses of Ranibizumab in Diabetic Macular Edema - the MINIMA 2 Study
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment
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