ArticleJournal of ophthalmology2015
Ranibizumab for Visual Impairment due to Diabetic Macular Edema: Real-World Evidence in the Italian Population (PRIDE Study).
Article in Journal of ophthalmology, 2015. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 11 papers.
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Who cites it
11 citing papers in PubMed, 22 citations in OpenAlex.
- Comparisons of Efficacy of Intravitreal Aflibercept and Ranibizumab in Eyes with Diabetic Macular Edema.BioMed research international · 2017Trial
- Real-World Experience with Brolucizumab Compared to Aflibercept in Treatment-Naïve and Therapy-Refractory Patients with Diabetic Macular Edema.Journal of clinical medicine · 2024Article
- A real-world data analysis of ocular adverse events linked to anti-VEGF drugs: a WHO-VigiAccess study.Frontiers in pharmacology · 2024Article
- Treatment results of diabetic macular edema with different choroidal thickness with intravitreal anti vascular endothelial growth factor.BMC ophthalmology · 2022Article
- Real-life experience of ranibizumab for diabetic macular edema in Taiwan.International ophthalmology · 2019Article
- One-year outcomes of novel VEGF decoy receptor therapy with intravitreal conbercept in diabetic retinopathy-induced macular edema.Molecular vision · 2019Article
- Diabetic macular edema: Evidence-based management.Indian journal of ophthalmology · 2018Review
- Efficacy of One-Year Treatment with Aflibercept for Diabetic Macular Edema with Practical Protocol.BioMed research international · 2017Article
- Estimation of the need for bilateral intravitreal anti-VEGF injections in clinical practice.BMC ophthalmology · 2016Article
- The real life data of ranibizumab use among the diabetic macular edema patients in Turkey: Documenting the improvement with clinical optimization during three consecutive years.Saudi journal of ophthalmology : official journal of the Saudi Ophthalmological SocietyArticle
- Evaluation of Patients Receiving Intravitreal Antivascular Endothelial Growth Factor for Diabetic Macular Edema in Clinical Practice in the United States.Journal of vitreoretinal diseasesArticle
Corrections and comments
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Authors and funding
8 authors at 7 institutions in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.