Clinical Study to Evaluate PRO-169 for Diabetic Macular Edema
442 patients around the world
Available in Mexico, Colombia
A total of 442 patients with diabetic macular edema will be randomized 1:1 to be treated with
either PRO-169 (bevacizumab) or Lucentis® (ranibizumab). There will be a total of 14 visits,
including selection and final visits. Monthly evaluations will include ophthalmologic
evaluations of anterior and posterior segments, as well as OCT (optic coherence tomography)
to obtain central macular width and retinal volume. Fluorescein angiography will be performed
on selection visit as well as 6 and 12 months into the study (visits 7 and 13). All patients
will be exposed to intravitreal injection of either of the studied drugs monthly for the
first 4 months. Starting on visit 5 patients will be injected depending on their response to
treatment, calculated according predetermined algorithms including clinical and image
variables. Starting on month 6, patients may be subjected to rescue therapy with
photocoagulation if they comply with predetermined criteria for such measure.