Evaluation of Injection Frequency and Visual Acuity Outcomes for Ranibizumab Monotherapy in Exudative Age-related Macular Degeneration

Dadgostar, Hajir; Ventura, Alexandre A.C.M.; Chung, Jeffrey Y.; Sharma, Sumit; Kaiser, Peter K.

doi:10.1016/j.ophtha.2009.05.033

Cited by 120 publications

(84 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Unclassified

Order By: Relevance

“…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: 82%

“…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%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionsupporting

confidence: 82%

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

View full text Add to dashboard Cite

show abstract

“…Anyhow, several studies have shown that the mean number of injections may not be too much reduced without loss of efficacy. [24][25][26] The main purpose of this study was to describe a way to apply the individually needed injections with reduced number of visits in order to offer a regimen that would contribute to fight against the real-life danger of undertreatment and visual loss. 27 In the absence of monthly evaluation visits, one may be concerned about potential undertreatment in the case of a rapidly changing need for injections.…”

mentioning

confidence: 99%

Two-year outcome of an observe-and-plan regimen for neovascular age-related macular degeneration: how to alleviate the clinical burden with maintained functional results

Gianniou

Dirani

Ferrini

et al. 2014

Eye

View full text Add to dashboard Cite

Two-year outcome of an observeand-plan regimen for neovascular age-related macular degeneration: how to alleviate the clinical burden with maintained functional results This article has been corrected since advance online publication and a corrigendum is also printed in this issue C Gianniou, A Dirani, W Ferrini, L Marchionno, D Decugis, A Deli, A Ambresin and I Mantel AbstractPurpose The purpose of this study was to report the 2-year outcome of an individually tailored 'observe-and-plan' treatment regimen for neovascular age-related macular degeneration (nAMD), and to investigate its clinical value in terms of functional outcome. This regimen aimed to reduce the clinical burden (visits) by employing individually fixed injection intervals, based on the predictability of an individual's need for retreatment. Methods This prospective case series included 104 patients (115 eyes) with nAMD. Following three loading doses of ranibizumab, the disease recurrence interval was determined in monthly observation visits. Retreatment was applied in a series of three injections with individually fixed intervals (2 weeks shorter than the recurrence interval), combined with periodic adjustment of the intervals. The allowed injection intervals in treatment plans ranged from 1 to 3 months. If there was no recurrence at 3 months, the patient could change to monitoring alone. Results Mean visual acuity (VA) improved by 8.7, 9.7, and 9.2 letters at months 3, 12, and 24, respectively. The mean number of injections was 7.8 and 5.8 during years 1 and 2, respectively, whereas the mean number of ophthalmic examinations was 4.0 and 2.9, respectively. The mean treatment interval (after the loading doses) was 2.0 months during year 1, and 2.2 months during year 2. Conclusion The observe-and-plan regimen significantly improved and maintained VA over the course of 2 years. This favourable functional outcome was achieved with fewer clinic visits compared with other regimens. Therefore, this observe-and-plan regimen has the potential to alleviate the clinical burden of nAMD treatment.

show abstract

“…There are, however, some differences between their patient and the patients we have described in our case series. 2 None of our patients had visible pigment in the chamber angle. None of our patients had an alteration of Correspondence visual acuity.…”

Section: Conflict Of Interestmentioning

confidence: 62%

“…2 We agree that myopia cannot be assessed accurately only with refraction. In some patients lenticular changes could contribute to a certain amount of myopia.…”

Section: Conflict Of Interestmentioning

confidence: 76%

Responding letter

Bettink-Remeijer

2010

Eye

View full text Add to dashboard Cite

Evaluation of Injection Frequency and Visual Acuity Outcomes for Ranibizumab Monotherapy in Exudative Age-related Macular Degeneration

Cited by 120 publications

References 13 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

Two-year outcome of an observe-and-plan regimen for neovascular age-related macular degeneration: how to alleviate the clinical burden with maintained functional results

Responding letter

Contact Info

Product

Resources

About