&lt;p&gt;Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study&lt;/p&gt;

Callizo, Josep; Ziemssen, Focke; Bertelmann, Thomas; Feltgen, Nicolas; Vögeler, Jessica; Koch, Mirja; Eter, Nicole; Liakopoulos, Sandra; Schmitz-Valckenberg, Steffen; Spital, Georg

doi:10.2147/opth.s209253

Cited by 33 publications

(40 citation statements)

References 30 publications

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“…Treatments in the present study were withheld when vision was good, which could have led to the fewer treatments and the thickened maculae in our cohort. The visual and anatomic outcomes of CRVO at 12 months in the present study were inferior and the number of treatments fewer than those reported in studies in routine clinical practice [ 15 – 17 ]. Neovascularization on the retina and iris in our cohort was more frequent than reported in those studies.…”

Section: Discussioncontrasting

confidence: 94%

“…The anatomical outcome mirrored functional outcome in BRVO however, it did not for CRVO which was also observed in a study that evaluated the outcomes of ranibizumab for RVO in routine clinical practice in Denmark [ 14 ]. The mean VA which was worse at baseline in CRVO in the present study remained so at 12 months which was similar to those reported in other observational studies of RVO [ 15 – 17 ]. There were fewer eyes with VA ≤ 0.3 logMAR (20/40) and more with VA ≥ 1 logMAR (20/200) at 12 months in CRVO than in BRVO.…”

Section: Discussionsupporting

confidence: 92%

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Treatment outcomes of retinal vein occlusion in clinical practice in Nepal

et al. 2021

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Background This study evaluated the treatment outcomes of retinal vein occlusion (RVO) in a routine clinical practice in Nepal. Methods This was a retrospective analysis of observational data of patients with RVO who attended the retina clinic of the Tilganga Institute of Ophthalmology from 1 November 2017 to 31 October 2018. The main outcome was the mean change in visual acuity (VA) at 12 months from the start of treatment. Other outcomes of interest were the mean change in central subfield thickness (CST) and the number of treatments over 12 months. Results A total of 99 eyes (of 99 patients) with RVO (60 - branch RVO [BRVO] and 39 - central RVO [CRVO] were available for the analysis. Eyes with CRVO had worse VA and CST at baseline. Eyes in both groups were similar for age, associated factors for RVO, duration of vision loss and the presence of ischemia at baseline. The mean (95% Confidence Interval [CI]) VA change at 12 months for BRVO was − 0.35 (− 0.46, − 0.23) logMAR (p < 0.001) from a mean (SD) of 0.75 (0.42) logMAR at baseline with 63% achieving VA < 0.3 logMAR while for CRVO it was − 0.35 (− 0.46, − 0.23) logMAR (p = 0.19) from 1.13 (0.61) logMAR at baseline and VA < 0.3 logMAR in 36%. The mean (95% CI) change in CST over 12 months was − 114 (− 189, − 40) μm (p = 0.003) from a mean (SD) of 423 (151) μm at baseline for BRVO and − 184(− 276, − 91) μm (p < 0.001) from 519 (213) μm for CRVO. Patients in both groups received a median of 2 bevacizumab injections over 12 months. Around 37% eyes were lost before 12 months’ observation. The mean VA and CST trajectory in these eyes at their last visit was similar to those that completed 12 months. Conclusion The outcomes of RVO over the 12 months were inferior and the number of treatments fewer than those of the clinical trials and other reports from routine clinical practice. Future studies to identify the treatment barriers are warranted to improve the treatment outcomes in our patients.

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Section: Discussioncontrasting

confidence: 94%

Section: Discussionsupporting

confidence: 92%

Treatment outcomes of retinal vein occlusion in clinical practice in Nepal

et al. 2021

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“…All these factors lead to potential under-treatment. Similarly, other real world studies have shown annual injection frequency ranging from 3 to 5 in RVO [11][12][13][14][15][16].…”

Section: Discussionmentioning

confidence: 52%

Sub-optimal gain in vision in retinal vein occlusion due to under-treatment in the real world: results from an open-label prospective study of Intravitreal Ranibizumab

Narayanan

Kelkar²,

Abbas

et al. 2021

BMC Ophthalmol

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Background Macular edema secondary to retinal vein occlusion (RVO) is an important cause of loss of vision. Intravitreal injections (IVI) of anti-vascular endothelial growth factor (VEGF) are the standard of care in this disease, as shown in numerous randomized controlled trials. The purpose of this study was to study the efficacy and safety of ranibizumab, an anti-VEGF agent, in the real-world setting. Methods This was 48 weeks, open-label, prospective, multicentre, observational study. Patients diagnosed with ME secondary to RVO were treated with IVI of Ranibizumab 0.5 mg in real-world conditions. Efficacy was measured by improvement seen in best-corrected visual acuity (BCVA) in terms of Early Treatment of Diabetic Retinopathy Study (ETDRS) Letter Scores and change in central retinal thickness (CRT) measured by optical coherence tomography. Results One hundred eyes of 100 patients (79 with branch retinal vein occlusion and 21 with central retinal vein occlusion) were recruited in the study. The mean (standard deviation, SD) BCVA was 52.8 (21.99) letters at baseline and 62.3 (24.40) letters at week 48. From baseline, there was a significant improvement in BCVA by 7.7 letters (p = 0.001) at 48 weeks. The mean (SD) of CRT was 479.9 (216.25) μm at baseline and it decreased significantly to 284.9 (171.35) μm at week 48 (p < 0.001). During the study period, the average number of intravitreal injections was 3.5 per patient. There was no report of endophthalmitis in any eye. Conclusions Ranibizumab is well tolerated and effective in treating macular edema secondary to RVO in real-world clinical settings. However, there is under-treatment compared to controlled clinical trials, and the gain in vision is sub-optimal with under-treatment. Trial registration Clinical Trials Registry - India: CTRI/2015/07/005985.

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“…The visual and anatomic outcomes of CRVO at 12 months in the present study were inferior and the number of treatments fewer than those reported in studies in routine clinical practice. [15][16][17] Neovascularization on the retina and iris in our cohort was more frequent than reported in those studies. Neovascularization and the need of panretinal laser may be unnecessary in eyes that receive adequate treatment for vascular retinal diseases.…”

Section: Discussionmentioning

confidence: 58%

“…[14] The mean VA which was worse at baseline in CRVO in the present study remained so at 12 months which was similar to those reported in other observational studies of RVO. [15][16][17] There were fewer eyes with VA ≤ 0.3 logMAR (6/12) and more with VA ≥ 1 logMAR (6/60) at 12 months in CRVO than in BRVO. The degree of macular edema and the subsequent photoreceptor damage could have limited visual recovery in CRVO despite the improvement in the mean CST.…”

Section: Discussionmentioning

confidence: 99%

Treatment Outcomes of Retinal Vein Occlusion in Clinical Practice in Nepal

Bhandari

Poudel

Paudyal

et al. 2020

Preprint

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Background: This study evaluated the treatment outcomes of retinal vein occlusion (RVO) in a routine clinical practice in Nepal. Methods: This was a retrospective analysis of observational data of patients with RVO who attended the retina clinic of the Tilganga Institute of Ophthalmology from 1 November 2017 to 31 October 2018. The main outcome was the mean change in visual acuity (VA) at 12 months from the start of treatment. Other outcomes of interest were the mean change in central subfield thickness (CST) and the number of treatments over 12 months. Results: A total of 99 eyes (of 99 patients) with RVO (60 - branch RVO [BRVO] and 39 - central RVO [CRVO] were available for the analysis. Eyes with CRVO had worse VA and CST at baseline. Eyes in both groups were similar for age, associated factors for RVO, duration of vision loss and the presence of ischemia at baseline. The mean (95% Confidence Interval [CI]) VA change at 12 months for BRVO was -0.35 (-0.46, -0.23) logMAR (p < 0.001) from a mean (SD) of 0.75 (0.42) logMAR at baseline with 63% achieving VA < 0.3 logMAR while for CRVO it was -0.35 (-0.46, -0.23) logMAR (p = 0.19) from 1.13 (0.61) logMAR at baseline and VA < 0.3 logMAR in 36%. The mean (95% CI) change in CST over 12 months was -114 (-189, -40) µm (p = 0.003) from a mean (SD) of 423 (151) µm at baseline for BRVO and -184(-276, -91) µm (p < 0.001) from 519 (213) µm for CRVO. Patients in both groups received a median of 2 bevacizumab injections over 12 months. Around 37% eyes were lost before 12 months’ observation. The mean VA and CST trajectory in these eyes at their last visit was similar to those that completed 12 months. Conclusion: The outcomes of RVO are inferior and the number of treatments over the 12 months fewer than those of clinical trials and other reports from routine clinical practice. Future studies to identify the barriers for undertreatment in our practice are warranted to improve the treatment outcomes.

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<p>Real-World Data: Ranibizumab Treatment For Retinal Vein Occlusion In The OCEAN Study</p>

Cited by 33 publications

References 30 publications

Treatment outcomes of retinal vein occlusion in clinical practice in Nepal

Treatment outcomes of retinal vein occlusion in clinical practice in Nepal

Sub-optimal gain in vision in retinal vein occlusion due to under-treatment in the real world: results from an open-label prospective study of Intravitreal Ranibizumab

Treatment Outcomes of Retinal Vein Occlusion in Clinical Practice in Nepal

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