Real-life clinical data for dexamethasone and ranibizumab in the treatment of branch or central retinal vein occlusion over a period of six months

Winterhalter, Sibylle; Eckert, Annabelle; Brocke, Gerrit Alexander vom; Schneider, Alice; Pohlmann, Dominika; Pilger, Daniel; Joussen, Antonia M.; Rehák, Matúš; Grittner, Ulrike

doi:10.1007/s00417-017-3852-1

Cited by 11 publications

(8 citation statements)

References 30 publications

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“…Unlike them, we found that dex imp group has lower CMT and higher BCVA at month six. In a recent study, Sibylle et al compared dexamethasone and ranibizumab in BRVO and CRVO patients (24). Similar to our study, they performed additional dex imp based on clinical data.…”

Section: Discussionsupporting

confidence: 72%

A Real-Life Study: Intravitreal Aflibercept, Ranibizumab and Dexamethasone For Macular Edema Secondary to Branch Retinal Vein Occlusion

Bayat¹

2019

Beyoglu Eye J

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This study aims to compare the efficacy of intravitreal injection of aflibercept (IVA), ranibizumab (IVR) and dexamethasone implant (DEX IMP) for the treatment of macular edema (ME) secondary to branch retinal vein occlusion (BRVO). Methods: In this retrospective and comparative study, 57 eyes of 57 patients with ME after BRVO were studied. Patients were diveded into three groups according to treatment regimen as follows: 2 mg IVA (group 1, n=18), 0,5 mg IVR (group 2, n=20) and 0,7 mg Dex imp (group 3, n=19). Group 1 and group 2 were treated with three monthly anti-VEGF treatment followed by pro re nata (PRN) regimen, and group 3 was treated with 0,7 mg dexamethasone dose followed by another injection based on patients' data. Best-corrected visual acuity (BCVA), central macular thickness (CMT), intraocular pressure (IOP) measurements were noted at baseline, 1, 2, 3 and 6 months. Results: All groups were similar concerning age, gender, duration of symptoms, initial CMT and BCVA (p>0.05). Mean number of injections were 3,85±0.74 in group 1, 3,85±0,87 in group 2 and 1,75±0,44 in group 3. All the groups decreased CMT and increased BCVA for six months. There was not a statistically significant difference between groups. Concerning side effects, one person in group 1 and 2, four people in group 3 increased IOP, but all of them controlled IOP with antiglaucomatous drugs. One patient in group 1, two in group 2, four in group three patients had cataract progression. Conclusion: All three drugs have similar results in patients with ME secondary to BRVO at a six-month follow-up. Compared to anti-VEGF drugs, dex imp has side effects as increased IOP and cataract progression, but it has higher BCVA at all months in the treatment of ME after BRVO.

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Section: Discussionsupporting

confidence: 72%

A Real-Life Study: Intravitreal Aflibercept, Ranibizumab and Dexamethasone For Macular Edema Secondary to Branch Retinal Vein Occlusion

Bayat¹

2019

Beyoglu Eye J

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“…12 We found only one study that compared anti-VEGF and other treatments using real world data, that of Winterhalter et al who present data on visual acuity after 6 months of treatment with ranibizumab (n=58) or dexamethasone (n=48) and found improvements in the mean visual acuity of both groups (from 59.5 to 67 and from 54.5 to 65.5). 13 The UK EMR Users group has previously analysed data obtained from an electronic medical record (EMR), first looking at patients with age-related macular degeneration and then patients with diabetic macular oedema. They found that real world visual outcomes were not as good as those in clinical trials but that the studied treatments were nevertheless effective, and effective in wider populations than were included within the criteria of relevant trials.…”

Section: Introductionmentioning

confidence: 99%

Real world evidence on 5661 patients treated for macular oedema secondary to branch retinal vein occlusion with intravitreal anti-vascular endothelial growth factor, intravitreal dexamethasone or macular laser

Gale¹,

Pikoula

Lee

et al. 2020

Br J Ophthalmol

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Background/aimsClinical trials suggest anti-vascular endothelial growth factor is more effective than intravitreal dexamethasone as treatment for macular oedema secondary to branch retinal vein occlusion. This study asks if ‘real world’ data from a larger and more diverse population, followed for a longer period, also support this conclusion.MethodsData collected to support routine care at 27 NHS (National Health Service) Trusts between February 2002 and September 2017 contained 5661 treatment-naive patients with a single mode of treatment for macular oedema secondary to branch retinal vein occlusion and no history of cataract surgery either during or recently preceding the treatment. Number of treatment visits and change in visual acuity from baseline was plotted for three treatment groups (anti-vascular endothelial growth factor (anti-VEGF), intravitreal dexamethasone, macular laser) for up to 3 years.ResultsMean baseline visual acuity was 57.1/53.1/62.3 letters in the anti-VEGF/dexamethasone/macular laser groups, respectively. This changed to 66.72 (+9.6)/57.6 (+4.5)/63.2 (+0.9) at 12 months. Adequate numbers allowed analysis at 18 months for all groups (66.6 (+9.5)/56.1 (+3.0)/60.8 (-1.5)) and for anti-VEGF at 36 months (68.0, +10.9) Mean number of treatments were 5.1/1.5/1.2 at 12 months, 5.9/1.7/1.2 at 18 months for all three groups and 10.3 at 36 months for anti-VEGF.ConclusionsVisual acuity improvements were higher and more sustained with anti-VEGF. Higher treatment burden occurred with anti-VEGF but this reduced over 36 months. Patients with better vision at baseline than those in the clinical trials maintained high levels of vision with both anti-VEGF and dexamethasone.

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“… Non-naive 32 66.5 (12.9) 56.2 Retrospective, multi-centre 48.7 ± 30.2 weeks Ozkaya et al [ 50 ] Turkey Dexamethasone 0.7 mg Single implant then PRN regimen. Naive 41 63.1 (11.1) 46.3 Retrospective, single-centre 24 Winterhalter et al [ 43 ] Germany Dexamethasone 0.7 mg Single implant then PRN regimen. Non-naive 31 c c Retrospective, single-centre 6 Yoon et al [ 44 ] South Korea Dexamethasone 0.7 mg Single implant then 4 monthly PRN regimen.…”

Section: Resultsmentioning

confidence: 99%

“… Unclear 54 65 50 Retrospective, single-centre 12 Osaka et al [ 110 ] Japan Ranibizumab 0.5 mg Single injection then monthly PRN regimen Naive 32 68.1 (11.1) 53.13 Prospective, single-centre 12 Ozkaya et al [ 50 ] Turkey Ranibizumab 0.5 mg Three monthly injections then monthly PRN regimen. Naive 46 60.8 (8.7) 30.4 Retrospective, single-centre 24 Winterhalter et al [ 43 ] Germany Ranibizumab 0.5 mg Three monthly injections, then further sets of 3 monthly injections PRN if active disease. Naive 27 c c Retrospective, single-centre 6 Son et al a [ 94 ] South Korea Ranibizumab 0.5 mg Three monthly injections then PRN regimen.…”

Section: Resultsmentioning

confidence: 99%

A systematic review of real-world evidence of the management of macular oedema secondary to branch retinal vein occlusion

Ang

Ah-Moye

Kim

et al. 2020

Eye

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This review assessed the real-world evidence of the management of macular oedema secondary to branch retinal vein occlusion (BRVO). A meta-analysis of 2530 eyes from 48 real-world studies of therapies for macular oedema secondary to BRVO was conducted. Baseline characteristics, visual, anatomical and safety outcomes were recorded. The weighted mean and weighted estimates from random-effects models were calculated for visual acuity (VA) and central subfield thickness (CST) changes at 6, 12 and 24 months. Primary outcome was change in VA (logMAR letters) at 12 months. Study quality was assessed using the quality appraisal checklist for case series developed by Institute of Health Economics. The mean baseline VA for the pooled data was 54.0 (51.5, 56.5) letters and the mean baseline CST was 501.3 (483.5, 519.1) µm. The random-effects estimate for mean (95% CI) change in VA was 14.6 (12.5, 16.7) letters at 12 months ( n = 1727). The random-effects estimate for mean (95% CI) change in CST was −181.7 (−230.7, −132.7) µm at 12 months ( n = 1325). The quality of studies varied considerably. Ocular and systemic adverse events were discussed in 79% and 42% of treatment arms respectively, with possible under-reporting. Visual and anatomical gains achieved in the real-world for anti-VEGF therapy were not as impressive as seminal RCTs, possibly due to reduced injection frequency in the real world and differences in baseline characteristics. There is an urgent need for consensus on the minimum efficacy, treatment burden and safety data to collect to strengthen the real-world evidence base.

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Real-life clinical data for dexamethasone and ranibizumab in the treatment of branch or central retinal vein occlusion over a period of six months

Abstract: In a clinical setting, comparable improvement in BCVA and CRT were observed after DEX and IVR injections for treatment of BRVO. CRVO patients showed greater benefit with IVR.

Cited by 11 publications

References 30 publications

A Real-Life Study: Intravitreal Aflibercept, Ranibizumab and Dexamethasone For Macular Edema Secondary to Branch Retinal Vein Occlusion

A Real-Life Study: Intravitreal Aflibercept, Ranibizumab and Dexamethasone For Macular Edema Secondary to Branch Retinal Vein Occlusion

Real world evidence on 5661 patients treated for macular oedema secondary to branch retinal vein occlusion with intravitreal anti-vascular endothelial growth factor, intravitreal dexamethasone or macular laser

A systematic review of real-world evidence of the management of macular oedema secondary to branch retinal vein occlusion

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