Individualized Stabilization Criteria–Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion

Tadayoni, Ramin; Waldstein, Sebastian M.; Boscia, Francesco; Gerding, H.; Pearce, Ian; Priglinger, Siegfried; Wenzel, Andreas; Barnes, Elizabeth H; Gekkieva, Margarita; Pilz, Stefan; Monés, Jordi

doi:10.1016/j.ophtha.2016.02.030

Cited by 78 publications

(113 citation statements)

References 18 publications

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“…The long-term CRYSTAL study demonstrated that ranibizumab treatment effectively reduced the proportion of patients with SRF by 24 months [41]. The BRIGHTER study reported a decreased proportion of patients with visible IRF and SRF 6 months after ranibizumab treatment [42]. Similar results were also observed in the current subgroup analysis, which showed a significant decrease in the proportion of patients with IRF or SRF after ranibizumab biosimilar treatment, again consistent with the original pooled analysis.…”

Section: Discussionsupporting

confidence: 86%

Real-Life Clinical Effectiveness of Razumab® (the World’s First Biosimilar of Ranibizumab) in Retinal Vein Occlusion: A Subgroup Analysis of the Pooled Retrospective RE-ENACT Study

Sharma¹,

Khan²,

Chaturvedi³

2018

Ophthalmologica

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Background: This subgroup analysis of the RE-ENACT study evaluates the effectiveness of Razumab® (the world’s first biosimilar of ranibizumab by Intas Pharmaceuticals Ltd.) in Indian patients with retinal vein occlusion (RVO). Methods: The data on patients with RVO who had received ≥3 injections of Razumab® between January and August 2016 were analyzed. Endpoints were: improvement in best corrected visual acuity (BCVA), and a decrease in central macular thickness (CMT), intraretinal fluid (IRF), and subretinal fluid (SRF) from baseline at weeks 4, 8, and 12. Results: Of 160 patients, the majority (61.87%) were men. The mean (±SE) BCVA improved from baseline (0.76 ± 0.04) to week 4 (0.73 ± 0.03; p = 0.0656), which attained significance at week 8 (0.55 ± 0.02; p < 0.0001) and week 12 (0.47 ± 0.02; p < 0.0001). The mean (±SE) CMT significantly decreased from baseline (447.60 ± 10.91 μm) to week 4 (431.84 ± 10.92 μm; p = 0.0028), week 8 (339.28 ± 8.12 μm; p < 0.0001), and week 12 (298.23 ± 6.68 μm; p < 0.0001). The proportion of patients with IRF and SRF significantly (p < 0.0001) decreased from baseline to weeks 4, 8, and 12 (IRF: from 70.63 to 45.63, 39.38, and 30.00%, respectively; SRF: from 65.63 to 37.50, 28.13, and 24.38%, respectively). A subgroup analysis of branch RVO and central RVO showed similar results. No new safety concerns were observed. Conclusion: Razumab® (biosimilar of ranibizumab) effectively improved visual acuity and disease outcomes in patients with RVO in a real-world setting with no new safety concerns.

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Section: Discussionsupporting

confidence: 86%

Real-Life Clinical Effectiveness of Razumab® (the World’s First Biosimilar of Ranibizumab) in Retinal Vein Occlusion: A Subgroup Analysis of the Pooled Retrospective RE-ENACT Study

Sharma¹,

Khan²,

Chaturvedi³

2018

Ophthalmologica

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“…In the CRYSTAL and BRIGHTER trials (PRN), mean VA change from baseline at month 6 and 12 was higher in patients with a lower baseline BCVA compared with those with a higher baseline BCVA [20, 22]. Our study showed a similar correlation: low baseline VA resulted in higher VA gain during 12 months compared to high VA.…”

Section: Discussionsupporting

confidence: 75%

Spectral-Domain Optical Coherence Tomography-Driven Treat-and-Extend and Pro Re Nata Regimen in Patients with Macular Oedema due to Retinal Vein Occlusion: 24-Month Evaluation and Outcome Predictors

et al. 2018

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Purpose: To analyse the efficacy and outcome predictors of ranibizumab using a spectral-domain optical coherence tomography (SD-OCT)-driven treat-and-extend regimen (TER) versus SD-OCT-driven pro re nata regimen (PRN) in patients with cystoid macular oedema (CME) due to branch or central retinal vein occlusion (BRVO, CRVO). Methods: Retrospective, consecutive case series. Evaluation included best corrected visual acuity (BCVA), morphological parameters on SD-OCT, and treatment frequency. Results: From baseline to months 12, 18, and 24, BCVA improved by 16.6 ± 13.1, 15.5 ± 14.4, and 16.6 ± 15.8 letters, respectively, in TER (n = 45), compared to 11.3 ± 17.0, 11.0 ± 15.0, and 10 ± 20.5 letters in PRN (n = 31) (p = 0.152, p = 0.237, p = 0.172). The mean reduction in central retinal thickness was –261 ± 189, –272 ± 188, and –264 ± 158 μm, respectively, in TER, compared to –130 ± 196, –140 ± 210, and –166 ± 207 μm in PRN (p = 0.006, p = 0.017, p = 0.064). 59% (53%) of TER and 22% (17%) of PRN patients showed no intra- or subretinal fluid on SD-OCT at 12 (24) months. Using TER, the maximum recurrence-free treatment interval increased from 8.9 ± 2.3 weeks at 12 months to 9.8 ± 2.3 and 10.5 ± 2.7 weeks at 18 and 24 months, respectively. The number of injections was significantly higher in the TER than in the PRN group. Conclusions: In CME, due to BRVO/CRVO, TER provides better morphological outcome using more injections than PRN.

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“…Both the BRAVO study ( n = 397) and the BRIGHTER study ( n = 455) demonstrated with ranibizumab a statistically significant superior improvement in best-corrected visual acuity (BCVA) compared with laser alone in patients with BRVO. No ocular side adverse effects (SAEs) were reported in this group [90, 107]. Although many studies claimed that intravitreal ranibizumab (IVR) can improve retinal nonperfusion, the effect was usually limited [108].…”

Section: Treatmentmentioning

confidence: 99%

New Developments in the Classification, Pathogenesis, Risk Factors, Natural History, and Treatment of Branch Retinal Vein Occlusion

Paulus

Shuai

et al. 2017

Journal of Ophthalmology

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For years, branch retinal vein occlusion is still a controversial disease in many aspects. An increasing amount of data is available regarding classification, pathogenesis, risk factors, natural history, and therapy of branch retinal vein occlusion. Some of the conclusions may even change our impression of branch retinal vein occlusion. It will be beneficial for our doctors to get a deeper understanding of this disease and improve the treatment skills. The aims of this review is to collect the information above and report new ideas especially from the past a few years.

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Individualized Stabilization Criteria–Driven Ranibizumab versus Laser in Branch Retinal Vein Occlusion

Abstract: Ranibizumab with an individualized VA-based regimen, with or without laser, showed statistically significant superior improvement in BCVA compared with laser alone in patients with BRVO. Overall, there were no new safety events other than those reported in previous studies.

Cited by 78 publications

References 18 publications

Real-Life Clinical Effectiveness of Razumab® (the World’s First Biosimilar of Ranibizumab) in Retinal Vein Occlusion: A Subgroup Analysis of the Pooled Retrospective RE-ENACT Study

Real-Life Clinical Effectiveness of Razumab® (the World’s First Biosimilar of Ranibizumab) in Retinal Vein Occlusion: A Subgroup Analysis of the Pooled Retrospective RE-ENACT Study

Spectral-Domain Optical Coherence Tomography-Driven Treat-and-Extend and Pro Re Nata Regimen in Patients with Macular Oedema due to Retinal Vein Occlusion: 24-Month Evaluation and Outcome Predictors

New Developments in the Classification, Pathogenesis, Risk Factors, Natural History, and Treatment of Branch Retinal Vein Occlusion

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