Efficacy and safety of ranibizumab with or without panretinal laser photocoagulation versus laser photocoagulation alone in proliferative diabetic retinopathy - the PRIDE study.

PRIDE study anti-VEGF therapy panretinal laser photocoagulation proliferative diabetic retinopathy ranibizumab retinal neovascularization

Journal

Acta ophthalmologica
ISSN: 1755-3768
Titre abrégé: Acta Ophthalmol
Pays: England
ID NLM: 101468102

Informations de publication

Date de publication:
Aug 2020
Historique:
received: 19 06 2019
accepted: 31 10 2019
pubmed: 7 12 2019
medline: 7 12 2019
entrez: 7 12 2019
Statut: ppublish

Résumé

Panretinal photocoagulation (PRP) is the current standard of care in proliferative diabetic retinopathy (PDR). However, treatment with anti-vascular endothelial growth factor agents might offer better patient outcomes with fewer side-effects. The PRIDE study aimed to assess the efficacy and safety of ranibizumab with or without PRP compared with PRP alone in patients with PDR. A total of 106 PDR patients without diabetic macular oedema were randomized to receive ranibizumab 0.5 mg monotherapy (n = 35), PRP (n = 35) or combined ranibizumab 0.5 mg/PRP (n = 36). The primary objective of this 12-month, multicentre, phase II study was to investigate the change in area of retinal neovascularization (NV). Complete regression of leakage and best-corrected visual acuity (BCVA) were key secondary end-points. At Month 12, there was a statistically significant difference of -2.83 mm² in the least square mean change in NV area between the ranibizumab monotherapy and PRP group, favouring ranibizumab (95% CI [-5.45; -0.21], p = 0.0344). At Month 3, 67%/0%/67% of the patients in the ranibizumab/PRP/combination groups, respectively, showed complete regression of leakage from NVs, while at Month 12, 28%/8%/18% showed complete regression of leakage from NVs. BCVA change was greater in the ranibizumab group compared with the PRP monotherapy group at Month 12 (+1.6 letters; 95% CI [-2.3; 5.5] versus -3.9 letters; 95% CI [-7.8; -0.1], p = 0.0495). Ranibizumab monotherapy is an alternative treatment option to laser treatment in patients with PDR. Ranibizumab showed stronger effects on NV leakage and area reduction while offering better visual acuity results than PRP alone.

Identifiants

pubmed: 31808278
doi: 10.1111/aos.14312
doi:

Types de publication

Journal Article

Langues

eng

Sous-ensembles de citation

IM

Pagination

e530-e539

Subventions

Organisme : Novartis Pharma GmbH

Informations de copyright

© 2019 The Authors. Acta Ophthalmologica published by John Wiley & Sons Ltd on behalf of Acta Ophthalmologica Scandinavica Foundation.

Références

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Auteurs

Gabriele E Lang (GE)

Department of Ophthalmology, University of Ulm, Ulm, Germany.

Andreas Stahl (A)

Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany.
Department of Ophthalmology, University Medical Center Greifswald, Greifswald, Germany.

Jessica Voegeler (J)

Novartis Pharma GmbH, Nuremberg, Germany.

Claudia Quiering (C)

Novartis Pharma GmbH, Nuremberg, Germany.

Katrin Lorenz (K)

University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany.

Georg Spital (G)

Eye Center at St. Franziskus-Hospital Muenster, Muenster, Germany.

Sandra Liakopoulos (S)

Cologne Image Reading Center, Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany.

Classifications MeSH