Purpose. An expanded access program (PRIDE study) in Italy to provide ranibizumab 0.5   mg to @entity1103 ( @entity1103 ) @entity1 , prior to reimbursement. Methods. Open-label, prospective, phase IIIb study. Majority of @entity1 were not treatment-na  ve before enrollment. @entity1 received ranibizumab as per the EU label (2011). Safety was assessed by incidences of ocular/systemic adverse events (AEs) and @entity137 ( @entity137 ) and efficacy in terms of visual acuity (VA) change from baseline (decimal score or Snellen (20/value)). Results. Overall, 515 @entity1 (83.5%) completed the study. In unilateral/bilateral @entity1 , commonly observed AEs were @entity299 (1.3%/1.3%) and @entity3002 (1.3%/1.1%); @entity137 were reported in 4.5%/4.8% of @entity1 . @entity810 , @entity2 , and @entity1167 were the causes of @entity204 in one unilateral and two bilateral @entity1 . Ranibizumab improved/maintained VA (Snellen (20/value)/decimal scores) in both unilateral (up to -16.7/1.5) and bilateral @entity1 (up to -23.6/1.2) at Month 5, with a mean of 4.15 and 4.40 injections, respectively. Overall, no difference was observed in the VA outcomes and treatment exposure between unilateral/bilateral @entity1 . Conclusions. The PRIDE study provided early ranibizumab access to >600 Italian @entity1 . Ranibizumab was well-tolerated and improved/maintained VA in 40.2%-68.8% @entity1 , with no differences in case of unilateral or bilateral pathology. The study is registered with EudraCT.

Ranibizumab for Visual Impairment due to XXXX : Real-World Evidence in the Italian Population (PRIDE Study).

@entity1 :: ('9606', 'Species') :: ['Patients', 'patients'] @entity137 :: ('MESH:D064420', 'Disease') :: ['SAEs', 'serious AEs'] @entity2 :: ('MESH:D008175', 'Disease') :: ['lung carcinoma'] @entity3002 :: ('MESH:D009421', 'Disease') :: ['nervous system disorders'] @entity1103 :: ('MESH:D008269', 'Disease') :: ['DME', 'diabetic macular edema'] @entity810 :: ('MESH:D058186', 'Disease') :: ['Acute renal failure'] @entity299 :: ('MESH:D006331', 'Disease') :: ['cardiac disorders'] @entity1167 :: ('MESH:D006323', 'Disease') :: ['cardiac arrest'] @entity204 :: ('MESH:D003643', 'Disease') :: ['death']
@entity1103 :: (MESH:D008269,Disease) :: ['Diabetic Macular Edema']
