Results of flexible ranibizumab treatment in age-related macular degeneration and search for parameters with impact on outcome

Gerding, H.; Loukopoulos, Vlassios; Riese, J.; Hefner, L.; Timmermann, M.

doi:10.1007/s00417-011-1636-6

Cited by 54 publications

(40 citation statements)

References 21 publications

(62 reference statements)

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“…Although substantial differences in efficacy could be seen compared to the clinical trials, the results from other observational studies on ranibizumab efficacy were in general similar to the current study (Dadgostar et al 2009;Rothenbuehler et al 2009;Querques et al 2010;Rotsos et al 2010;Gerding et al 2011;Gupta et al 2011;Cohen et al 2013;Finger et al 2013;Lala et al 2013;Rakic et al 2013;Wolf & Kampik 2014). Considering the treatment patterns, an apparent increase in long-term visual acuity was found in patients who completed the loading phase compared to a decrease in visual acuity in those who did not.…”

Section: Discussionsupporting

confidence: 83%

“…Observational studies located in several European countries have been conducted to evaluate the efficacy of ranibizumab for neovascular AMD in clinical practice in their respective countries (Dadgostar et al 2009;Rothenbuehler et al 2009;Querques et al 2010;Rotsos et al 2010;Gerding et al 2011;Gupta et al 2011;Cohen et al 2013;Finger et al 2013;Lala et al 2013;Rakic et al 2013;Wolf & Kampik 2014). Following marketing approval of ranibizumab for neovascular AMD, the Dutch Health Authority had requested an observational study to assess the effectiveness and safety of ranibizumab in daily clinical practice in the Netherlands.…”

Section: Introductionmentioning

confidence: 99%

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A prospective, observational, open‐label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age‐related macular degeneration

Asten¹,

Evers‐Birkenkamp

Lith-Verhoeven

et al. 2014

Acta Ophthalmologica

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ABSTRACT.Purpose: The HELIOS (Health Economics with Lucentis in Observational Settings) study was designed on request of the Dutch Health Authority for an observational study to assess the effectiveness and safety of ranibizumab for neovascular age-related macular degeneration (wet AMD) in daily practice. Methods: The HELIOS study was a 2-year prospective, observational, openlabel, multicentre study involving 14 sites. Patients with wet AMD were enrolled and observed for a period of 24 months. The data were collected at baseline and at the visits closest around the time-points 3, 6, 12, 18 and 24 months after inclusion. Results: Treatment with ranibizumab resulted in prevention of vision loss. The mean ETDRS score increased from 45.1 letters at baseline to 48.5 letters at 24 months. This was achieved with a mean of 7.8 injections over 24 months. Stabilization of visual acuity was also reflected by the scores on the quality of life EQ-5D questionnaire, which did not significantly change over the study period. The more subjective EQ-VAS questionnaire showed an overall improvement. The VFQ-25 questionnaire was also mostly stable over time. After 24 months, 32.2% of the patients gained ≥1 letter and 17.1% gained >15 letters. Patients completing the loading phase were better responders, as demonstrated by increased long-term visual acuity. In addition, ranibizumab was well tolerated and had a safety profile commonly seen in routine clinical practice. Conclusion: This study demonstrates that also in daily practice ranibizumab was effective in preventing vision loss over a period of 24 months. No new safety findings were identified.

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Section: Discussionsupporting

confidence: 83%

Section: Introductionmentioning

confidence: 99%

A prospective, observational, open‐label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age‐related macular degeneration

Asten¹,

Evers‐Birkenkamp

Lith-Verhoeven

et al. 2014

Acta Ophthalmologica

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“…Although p.r.n. regimens often have been associated with secondary functional losses after the loading dose [17][18][19], it has been shown that strict monthly visits and sensitive retreatment criteria may achieve good and durable functional results [8,20,21]. Our mean of 7.5 injections during the 12 months p.r.n.…”

Section: Discussionmentioning

confidence: 99%

Prospective study evaluating the predictability of need for retreatment with intravitreal ranibizumab for age-related macular degeneration

Mantel

Deli

Iglesias³

et al. 2012

Graefes Arch Clin Exp Ophthalmol

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Purpose To investigate the rhythm and predictability of the need for retreatment with intravitreal injections of ranibizumab for neovascular age-related macular degeneration (nAMD). Methods This prospective study enrolled 39 patients with treatment-naïve nAMD. After three loading doses of intravitreal ranibizumab, patients underwent an intensified follow-up for 12 months (initially weekly, then with stepwise increases to every 2 weeks and to monthly after each injection). Patients were retreated on an as-needed basis if any fluid or increased central retinal thickness (CRT) (>50μm) was found on spectral domain optical coherence tomography (OCT). Statistical analysis included patients who received at least two retreatments (five injections). Results A mean of 7.5 injections (range 0-12) were given between months 3 and 15. The mean visual acuity increased by 13.1 and 12.6 ETDRS letters at months 12 and 15 respectively. Two or more injection-retreatment intervals were found in 31 patients. The variability of their intra-individual intervals up to 14 weeks was small (SD 0-2.13 weeks), revealing a high regularity of the retreatment rhythm. The SD was correlated with the mean interval duration (r00.89, p< 0.001). The first interval was a good predictor of the following intervals (regression coefficient 00.81). One retreatment criterion was stable in 97 % of patients (cysts or subretinal fluid). Conclusion The results of this study demonstrate a high intra-individual predictability of retreatment need with ranibizumab injections for nAMD. These findings may be helpful for developing individualized treatment plans for maintained suppression of disease activity with a minimum of injections and visits.

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“…1,2 The recent study that compared pro re nata dosing strategies with monthly ranibizumab showed similar outcomes but the outcomes in real-life does not always mirror the clinical trial results. 3,4 Although the treating ophthalmologists are satisfied by a five-lettergain in vision, most patients struggle to read well while the others are unable to cope with more complex activities in their daily life.…”

Section: Introductionmentioning

confidence: 99%

Quality of fixation in eyes with neovascular age-related macular degeneration treated with ranibizumab

Sivaprasad

Pearce

Chong

2011

Eye

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Aims To define factors that determine the location and stability of fixation in patients with neovascular age-related macular degeneration (NV-AMD) treated with intravitreal ranibizumab injections. Methods The location and stability of fixation using microperimetry were determined in 77 eyes treated with ranibizumab for NV-AMD for at least 12 months. All patients were treated with three injections of ranibizumab 0.5 mg, 1 month apart and retreated according to predefined criteria. The fixation parameters were correlated to the visual acuity, and quantitative measures on OCT. Results The location of fixation was predominantly central in 52.6%, poor central fixation in 9.2%, and predominantly eccentric fixation in 38.2%. The fixation was stable in 65%, relatively unstable in 25%, and unstable in 10%. Visual acuity was the only factor that determined the stability and location of fixation. The characteristics of fixation were not related to the macular thickness or volume as measured by OCT. Conclusions Better visual outcome ensures central and stable fixation. Quantitative measures of OCT parameters do not determine fixation. Further studies on morphological features of the macula may provide some insight into the determinants of fixation.

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Results of flexible ranibizumab treatment in age-related macular degeneration and search for parameters with impact on outcome

Cited by 54 publications

References 21 publications

A prospective, observational, open‐label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age‐related macular degeneration

A prospective, observational, open‐label, multicentre study to investigate the daily treatment practice of ranibizumab in patients with neovascular age‐related macular degeneration

Prospective study evaluating the predictability of need for retreatment with intravitreal ranibizumab for age-related macular degeneration

Quality of fixation in eyes with neovascular age-related macular degeneration treated with ranibizumab

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