Gabriele E Lang1, Andreas Stahl2,3, Jessica Voegeler4, Claudia Quiering4, Katrin Lorenz5, Georg Spital6, Sandra Liakopoulos7. 1. Department of Ophthalmology, University of Ulm, Ulm, Germany. 2. Eye Center, Medical Center, Faculty of Medicine, University of Freiburg, Freiburg, Germany. 3. Department of Ophthalmology, University Medical Center Greifswald, Greifswald, Germany. 4. Novartis Pharma GmbH, Nuremberg, Germany. 5. University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany. 6. Eye Center at St. Franziskus-Hospital Muenster, Muenster, Germany. 7. Cologne Image Reading Center, Department of Ophthalmology, University Hospital of Cologne, Cologne, Germany.
Abstract
PURPOSE: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. METHODS: 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. RESULTS: 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). CONCLUSIONS: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.
RCT Entities:
PURPOSE: 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: 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.