Randomized, Double-Masked, Sham-Controlled Trial of Ranibizumab for Neovascular Age-Related Macular Degeneration: PIER Study Year 2

Abraham, Prema; Yue, Huibin; Wilson, Laura J.

doi:10.1016/j.ajo.2010.04.011

Cited by 308 publications

(176 citation statements)

References 10 publications

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“…Simply reducing the intravitreal injections to a fixed retreatment every 3 months was significantly inferior to monthly injections and resulted in the loss of initial visual acuity (VA) improvement. [8][9][10] Although the individually adjusted pro re nata (PRN) retreatment regimen was able to reduce the number of retreatments with (near) noninferiority of visual results as compared with monthly retreatment, 11,12 this regimen still requires monthly monitoring visits to detect disease recurrence and determine the need for retreatment. In a context of chronic care management and indefinite treatment duration, monthly monitoring visits place a heavy burden on ophthalmic institutions, with new patients being regularly added because of the high incidence of nAMD.…”

Section: Introductionmentioning

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

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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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Section: Introductionmentioning

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

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“…There is significant evidence demonstrating the efficacy of intravitreal ranibizumab in either improving or stabilising visual acuity in patients treated for CNV secondary to AMD. [24][25][26][27] Previous studies have demonstrated that ranibizumab has a prolonged effect in either stabilising or improving vision in CNV secondary to AS. 13 19 Vadalà et al 20 reported a series of nine patients who received 0.3 mg ranibizumab injections with a mean follow-up of 14 months.…”

Section: Discussionmentioning

confidence: 99%

Intravitreal ranibizumab for the treatment of choroidal neovascularisation secondary to angioid streaks

Shah

Amoaku

2012

Eye

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Aims To assess the medium to long-term efficacy and safety of intravitreal ranibizumab for the treatment of choroidal neovascularisation (CNV) secondary to angioid streaks (AS). Methods A total of 12 eyes of nine patients treated with intravitreal ranibizumab (0.5 mg in 0.05 ml) for CNV secondary to AS were retrospectively identified. Efficacy of treatment was determined by changes in best-corrected LogMAR visual acuity (BCVA) and optical coherence tomography. Changes with respect to baseline BCVA were defined as improved or reduced with a gain or loss of more than 10 letters, respectively, or stable if remaining within 10 letters. Results Over a mean follow-up of 21.75 months (range: 1-54), patients received mean 5.75 (range: 2-15) intravitreal ranibizumab injections per affected eye. BCVA improved in three eyes (25%), stabilised in eight eyes (66.67%), and deteriorated in one eye (8.33%). There was no significant change in central retinal thickness (CRT) over the follow-up period (P ¼ 0.1072). No drug-related systemic side effects were recorded. Conclusion The long-term treatment of CNV secondary to AS with intravitreal ranibizumab showed a stabilisation in CRT and an improvement or stabilisation of BCVA. The absence of systemic side effects was reassuring. Further long-term prospective studies are required to validate these findings.

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“…Ranibizumab (Lucentis â ) is a monoclonal antibody Fab fragment that inhibits neovascularization and leakage from vessels by binding to vascular endothelial growth factor A (VEGF-A) (Chen et al 1999;Rosenfeld et al 2006a,b). The efficacy of ranibizumab has been demonstrated in pivotal phase III trials (MARINA, ANCHOR and PIER) in which patients with choroidal neovascularization (CNV) associated with AMD receiving intravitreal injections of ranibizumab experienced a sustained improvement in mean visual acuity over time (Rosenfeld et al 2006a,b;Brown et al 2009;Abraham et al 2010). In addition, ranibizumab was well tolerated and considered safe (Rosenfeld et al 2006a,b;Mitchell et al 2010).…”

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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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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Randomized, Double-Masked, Sham-Controlled Trial of Ranibizumab for Neovascular Age-Related Macular Degeneration: PIER Study Year 2

Cited by 308 publications

References 10 publications

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

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

Intravitreal ranibizumab for the treatment of choroidal neovascularisation secondary to angioid streaks

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

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