Twelve-Month Efficacy and Safety of 0.5 mg or 2.0 mg Ranibizumab in Patients with Subfoveal Neovascular Age-related Macular Degeneration

Busbee, Brandon; Ho, Allen C.; Brown, David M.; Heier, Jeffrey S.; Suñer, Iván J.; Li, Zhengrong; Rubio, Roman G.; Lai, Phillip

doi:10.1016/j.ophtha.2012.10.014

Cited by 470 publications

(397 citation statements)

References 18 publications

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“…The 'observe-and-plan' regimen allows for elimination of monthly repeated evaluation visits during the treatment plans, thereby reducing the number of ophthalmic assessments to one-third (33%) and one-fourth (24%) during the first and second year, respectively, as compared with the monthly visits required in PRN regimens. 11,12,16 Thus far, various Figure 3 Distribution of the first measured interval after loading doses (horizontal axis), plotted against the last applied interval at month 24 (vertical axis), for all eyes that underwent treatment with ranibizumab for neovascular age-related macular degeneration according to the studied regimen 'observe and plan'. The term 'observation' is equivalent to any interval longer than 3 months.…”

Section: Discussionmentioning

confidence: 99%

“…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%

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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: Discussionmentioning

confidence: 99%

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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“…[9][10][11] The HABOR Study reported equivalent visual and anatomical outcomes between high dose (2.0 mg) and conventional dose (0.5 mg) of ranibizumab for treatment of exudative AMD at 12 months. 12 Stratification of lesion subtypes was not a part of these studies; therefore, its applicability to the more difficult-to-treat subtypes of neovascular AMD such as vPED is unknown. Recent studies evaluated the outcomes of ranibizumab for treating vPED due to AMD, but not comparing the results of various doses of ranibizumab.…”

Section: Introductionmentioning

confidence: 99%

“…Recent studies evaluated the outcomes of ranibizumab for treating vPED due to AMD, but not comparing the results of various doses of ranibizumab. 1,[6][7][8][9][10][11][12][13][14][15][16][17][18][19] Our prospective study addressed the benefits and risks of 2.0 vs 0.5 mg ranibizumab for treating vPED due to AMD on a monthly as well as pro-re nata (PRN) basis for up to 12 months.…”

Section: Introductionmentioning

confidence: 99%

Earlier therapeutic effects associated with high dose (2.0 mg) Ranibizumab for treatment of vascularized pigment epithelial detachments in age-related macular degeneration

Chan

Abraham

Sarraf

et al. 2014

Eye

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Summary statement Intravitreal high dose (2 mg) ranibizumab may lead to quicker resolution of choroidal neovascularization (CNV) and associated retinal pigment epithelial detachment in eyes with exudative age-related macular degeneration, although it may possibly correlate with RPE tears in certain cases. Purpose This prospective study compared the outcomes of 0.5 vs 2.0 mg intravitreal ranibizumab injections (RI) for treating vascularized pigment epithelial detachment (vPED) due to age-related macular degeneration. Methods Patients with vPED were randomized to receive 2.0 vs 0.5 mg RI monthly for 12 months or for 4 months and then repeated on a pro-re nata basis. Optical coherence tomography, fundus photography, and fluorescein and indocyanine-green angiography were obtained at baseline and subsequent specific intervals. Outcome measures were best-corrected standardized visual acuities, central 1-mm thickness, surface area (SA), greatest linear diameter (GLD), heights (PED and CNV), and amount of subretinal fluid (SRF) and cystoid macular edema (CME). Results Both groups yielded reductions of the central 1-mm thickness, PED and CNV SA and PED height and GLD, SRF, and CME. Vision improvement and reduction in SRF and PED height occurred earlier for eyes receiving the 2.0 mg dose. Cataract progression was similar but RPE tears developed more often with the 2.0 mg dose. Conclusions There were similar visual and anatomical outcomes at the end of the study; however, the higher dose yielded more rapid reductions and more complete resolution of the PED, although there was possible increased tendency for an RPE tear with the higher dose.

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“…In addition, doubling the dose has not been proven to increase the efficacy of ranibizumab in in the treatment of both age related macular degeneration and diabetic macular edema. 26,27 The READ-3 compared between 0.5 mg and 2.0 mg ranibizumab in the treatment of diabetic macular edema and found that after 6 months visual gains in the 0.5 mg group were higher (+9.43 letters) than the 2.0 mg group (+7.01 letters; P = 0.161). 28 In addition, the RISE/RIDE study found no significant difference between monthly 0.3 mg and the 0.5 mg dose of ranibizumab after 24 months of treatment.…”

Section: Drcr Protocol T-1 and 2-year Datamentioning

confidence: 99%

Aflibercept in diabetic macular edema: evaluating efficacy as a primary and secondary therapeutic option

Ashraf¹,

Souka²,

Adelman³

et al. 2016

Eye

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The recent results of Protocol T have illustrated the efficacy of aflibercept in the treatment of diabetic macular edema. It also demonstrated that in patients with poor vision (o6/12), aflibercept offers anatomical and visual advantages over ranibizumab and bevacizumab in the first 12 months of treament. At 2 years, the difference between the three drugs decreased with patients with a better baseline VA (69-78) showing a statistically insignificant advantage for ranibizumab compared with aflibercept. These results were achieved using a pro-re nata (PRN) protocol, which was not previously studied in large phase 3 trials, VIVID and VISTA, that chose to compare the 2.0 mg dose in a monthly and bimonthly regimen. In this review article, we analyzed earlier studies such as DAVINCI and VIVID and VISTA to determine which treatment strategy offers the best results; monthly, bimonthly, or PRN. We also studied the different doses for aflibercept used in DAVINCI to determine which is more effective the 0.5 mg dose or the 2.0 mg dose. In addition, we analyzed the recent data from protocol T with regards to visual and anatomic outcomes to try to determine whether these results concur with previous studies. Finally, we discuss the role of aflibercept as a potential alternative to any diabetic macular edema regimen regardless what the primary drug used is.

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Twelve-Month Efficacy and Safety of 0.5 mg or 2.0 mg Ranibizumab in Patients with Subfoveal Neovascular Age-related Macular Degeneration

Abstract: Proprietary or commercial disclosure may be found after the references.

Cited by 470 publications

References 18 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

Earlier therapeutic effects associated with high dose (2.0 mg) Ranibizumab for treatment of vascularized pigment epithelial detachments in age-related macular degeneration

Aflibercept in diabetic macular edema: evaluating efficacy as a primary and secondary therapeutic option

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