Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study)‎

الملخص EN

Purpose.

An expanded access program (PRIDE study) in Italy to provide ranibizumab 0.5 mg to diabetic macular edema (DME) patients, prior to reimbursement.

Methods.

Open-label, prospective, phase IIIb study.

Majority of patients were not treatment-naïve before enrollment.

Patients received ranibizumab as per the EU label (2011).

Safety was assessed by incidences of ocular/systemic adverse events (AEs) and serious AEs (SAEs) and efficacy in terms of visual acuity (VA) change from baseline (decimal score or Snellen (20/value)).

Results.

Overall, 515 patients (83.5%) completed the study.

In unilateral/bilateral patients, commonly observed AEs were cardiac disorders (1.3%/1.3%) and nervous system disorders (1.3%/1.1%); SAEs were reported in 4.5%/4.8% of patients.

Acute renal failure, lung carcinoma, and cardiac arrest were the causes of death in one unilateral and two bilateral patients.

Ranibizumab improved/maintained VA (Snellen (20/value)/decimal scores) in both unilateral (up to −16.7/1.5) and bilateral patients (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 patients.

Conclusions.

The PRIDE study provided early ranibizumab access to >600 Italian patients.

Ranibizumab was well-tolerated and improved/maintained VA in 40.2%–68.8% patients, with no differences in case of unilateral or bilateral pathology.

The study is registered with EudraCT.