An Optical Coherence Tomography-Guided, Variable Dosing Regimen with Intravitreal Ranibizumab (Lucentis) for Neovascular Age-related Macular Degeneration

Fung, Anne E.; Lalwani, Geeta A.; Rosenfeld, Philip J.; Dubovy, Sander R.; Michels, Stephan; Feuer, William J.; Puliafito, Carmen A.; Davis, Janet L.; Flynn, Harry W.; Esquiabro, Maria

doi:10.1016/j.ajo.2007.01.028

Cited by 922 publications

(774 citation statements)

References 7 publications

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“…The mean change in ETDRS letters after monthly injections of 0.5 mg ranibizumab varied between +5.9 for occult or minimally classic CNV and +9.8 for classic CNV after 3 months [13,38]. The observed increase in VA is also closely similar to the increase of 10.8 ETDRS letters after ranibizumab three times and additional injections when necessary based on OCT and VA change [21]. It is interesting to see that in the 1-year follow-up study of Bashur et al, fewer injections were needed than in the 1-year follow-up study on ranibizumab of Fung et al, with almost the same criteria for reinjection, knowing that the intravenous half-life of bevacizumab is 150% that of ranibizumab in rabbit eyes [5,6,8,21].…”

Section: Discussionsupporting

confidence: 54%

A systematic review on the effect of bevacizumab in exudative age-related macular degeneration

Schouten

Heij

Webers

et al. 2008

Graefes Arch Clin Exp Ophthalmol

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Aim To provide evidence for the effect of bevacizumab on visual acuity (VA) and central retinal thickness (CRT) in exudative age-related macular degeneration Methods A systematic review of all articles of bevacizumab for exudative AMD was conducted. Articles published up to March 2008 were identified in Medline, Embase, the Cochrane Controlled Trials Register and references from included articles. Search terms were "Bevacizumab or Avastin" and "Macula* or ARMD or AMD or intra(-) vitreal or intra(-)vitreous". Three observers participated in the data retrieval and assignment of the quality scores. Results A total of 561 articles were retrieved. Three randomised controlled trials (RCT) and 23 before-and-after studies of patients (n=1,435) who had received bevacizumab were published. Inclusion criteria varied. Lack of masking was the main methodological shortcoming. These RCTs showed that bevacizumab is more effective than PDT. Bevacizumab was given intravenously or as intravitreal injection. The latter was given once, or repeatedly every 4 weeks, and with or without additional injection when a recurrence occurred, mostly based on visual acuity and/or findings from optical coherence tomography. After intravenous administration, the weighted mean change in VA was +12.8 ETDRS letters (range +11 to +14) and the weighted mean change for CRT was −129 μm (range −100 to −202). For the 23 studies with intravitreal injections, the change in VA was +8.6 letters (range +2 to +26) and the change in CRT was −90 μm (range −46 to −190). The incidence of adverse events was low. The change in VA was 2.7 letters higher for studies with a higher quality vs lower quality. Conclusion Visual acuity improves and central retinal thickness decreases in patients with exudative AMD after bevacizumab. There is no reasonable doubt that this is caused by bevacizumab. It is likely that a randomised controlled trial will show that bevacizumab is equivalent in effect to ranibizumab, which showed a change in ETDRS of +5.9 letters for occult or minimally classic CNV and +9.8 letters for classic CNV after three monthly injections in two large RCTs.

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Section: Discussionsupporting

confidence: 54%

A systematic review on the effect of bevacizumab in exudative age-related macular degeneration

Schouten

Heij

Webers

et al. 2008

Graefes Arch Clin Exp Ophthalmol

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“…17,[19][20][21] Correspondingly, it was found that less-than-monthly assessment visits in PRN had a poorer outcome than strict monthly visits. 22 However, in a real-life setting, monthly assessments are a logistical problem, 23 requiring human resources and time investment from health-care providers as well as patients.…”

mentioning

confidence: 95%

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

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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.

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“…OCT is increasingly used to determine both the presence and activity of choroidal neovascularisation (CNV) and the need for treatment/retreatment in clinical trials and routinely in clinical practice. 10,11 OCT is noninvasive and quick to perform. It has therefore been suggested that OCT imaging may be sufficient in the diagnosis of nAMD, allowing prompt initiation of therapy.…”

Section: Introductionmentioning

confidence: 99%

The diagnostic accuracy of spectral-domain optical coherence tomography for neovascular age-related macular degeneration: a comparison with fundus fluorescein angiography

Wilde

Patel²,

Lakshmanan

et al. 2015

Eye

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An Optical Coherence Tomography-Guided, Variable Dosing Regimen with Intravitreal Ranibizumab (Lucentis) for Neovascular Age-related Macular Degeneration

Cited by 922 publications

References 7 publications

A systematic review on the effect of bevacizumab in exudative age-related macular degeneration

A systematic review on the effect of bevacizumab in exudative 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

The diagnostic accuracy of spectral-domain optical coherence tomography for neovascular age-related macular degeneration: a comparison with fundus fluorescein angiography

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