Safety and Efficacy of a Flexible Dosing Regimen of Ranibizumab in Neovascular Age-Related Macular Degeneration: The SUSTAIN Study

Holz, Frank G.; Amoaku, Winfried; Donate-López, J.; Guymer, Robyn H.; Kellner, Ulrich; Schlingemann, Reinier O.; Weichselberger, Andreas; Staurenghi, Giovanni

doi:10.1016/j.ophtha.2010.12.019

Cited by 375 publications

(290 citation statements)

References 17 publications

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“…[22][23][24][25] Where this is not possible, treatment initiation with three initiation (or so called 'loading') doses at monthly intervals followed by flexible dosing (PRN) based on monthly monitoring and VA/OCT guided re-treatment criteria achieve functional and morphological changes close to those achieved after the three initiation doses. 26,27 However, regular monthly monitoring is required to achieve optimal outcomes. As the risk of undertreatment is high in this treatment option, further refinement of monitoring has enabled a treat-to-target regimen where patients are monitored and injected monthly until a pre-defined target is achieved.…”

Section: Parameters Used To Assess Response To Anti-vegf Therapiesmentioning

confidence: 99%

“…Approximately 20-26% of eyes belong to the 'no initial VA gain' group. 27 Some may describe this as a partial response, where there is reduction of subretinal fluid (SRF) and intraretinal fluid (IRF) to 25 and 75% of the baseline but persistence of fluid. (c) Poor response is defined as no change in VA, that is, VA change of 0 or less letters (but not 44 letter loss) when associated with morphological features of poor response.…”

Section: Response Based On Change In Va In Terms Of Etdrs Lettersmentioning

confidence: 99%

“…It is recognised that patients on a PRN regime of anti-VEGFs for n-AMD require two or more re-treatments to control the lesion and regain lost vision following recurrences of CNV activity. 27 Similarly some eyes require more frequent injections of anti-VEGF agent than monthly dosing, such as 2-3 weekly in order to achieve primary response or following recurrences. 35 A post hoc analysis of the PIER study data shows that qualitative assessments of OCT at months 5 and 8 may determine those eyes that may require more treatment than the three monthly maintenance regime used in that study.…”

Section: Response Based On Change In Va In Terms Of Etdrs Lettersmentioning

confidence: 99%

See 2 more Smart Citations

Defining response to anti-VEGF therapies in neovascular AMD

Amoaku

Chakravarthy

Gale

et al. 2015

Eye

243

227

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Section: Parameters Used To Assess Response To Anti-vegf Therapiesmentioning

confidence: 99%

Section: Response Based On Change In Va In Terms Of Etdrs Lettersmentioning

confidence: 99%

Section: Response Based On Change In Va In Terms Of Etdrs Lettersmentioning

confidence: 99%

See 1 more Smart Citation

Defining response to anti-VEGF therapies in neovascular AMD

Amoaku

Chakravarthy

Gale

et al. 2015

Eye

243

227

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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: 98%

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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“…The phase 3 ranibizumab trials (MARINA 50 and ANCHOR 51 ) did not show a significantly elevated risk of thromboembolic events, but the Safety and Efficacy of a Flexible Dosing Regimen of Ranibizumab in Neovascular Age-Related Macular Degeneration (SUSTAIN) trial found a 10% incidence of stroke in treated patients with a history of preexisting cerebrovascular disease. 82 A meta-analysis of several ranibizumab trials showed a higher incidence of stroke in treated patients compared with controls (2.2% vs 0.7%; Pϭ.045), and an analysis using combined data showed an elevated risk (7.8% in the ranibizumab groups vs 4.2% in the controls) of nonocular hemorrhage (ecchymosis, gastrointestinal hemorrhages, hematomas, vaginal hemorrhages, and subdural hematomas). 83 Fortunately, no similar association was seen with myocardial infarction.…”

Section: Systemic Concernsmentioning

confidence: 99%

The Expanding Role of Vascular Endothelial Growth Factor Inhibitors in Ophthalmology

Stewart

2012

Mayo Clinic Proceedings

161

105

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Vascular endothelial growth factor (VEGF) plays an important role in both physiologic and pathologic angiogenesis and contributes to increased permeability across both the blood-retinal and blood-brain barriers. After 2 decades of extensive research into the VEGF families and receptors, specific molecules have been targeted for drug development, and several medications have received US Food and Drug Administration approval. Bevacizumab, a full-length antibody against VEGF approved for the intravenous treatment of advanced carcinomas, has been used extensively in ophthalmology for exudative age-related macular degeneration, diabetic retinopathy, retinal vein occlusions, retinopathy of prematurity, and other chorioretinal vascular disorders. Pegaptanib and ranibizumab have been developed specifically for intraocular use, whereas the soon-to-be-introduced aflibercept (VEGF Trap-Eye) is moving through clinical trials for both intraocular and systemic use. Although these drugs exhibit excellent safety profiles, ocular and systemic complications, particularly thromboembolic events, remain a concern in patients receiving therapy. Patients experiencing adverse events that may be related to VEGF suppression should be carefully evaluated by both the ophthalmologist and the medical physician to reassess the need for intraocular therapy and explore the feasibility of changing medications. For this review a search of PubMed from January 1, 1985 through April 15, 2011, was performed using the following terms (or combination of terms): vascular endothelial growth factors, VEGF, age-related macular degeneration, diabetic retinopathy, retina vein occlusions, retinopathy of prematurity, intravitreal injections, bevacizumab, ranibizumab, and VEGF Trap. Studies were limited to those published in English. Other articles were identified from bibliographies of retrieved articles and archives of the author.

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Safety and Efficacy of a Flexible Dosing Regimen of Ranibizumab in Neovascular Age-Related Macular Degeneration: The SUSTAIN Study

Cited by 375 publications

References 17 publications

Defining response to anti-VEGF therapies in neovascular AMD

Defining response to anti-VEGF therapies in neovascular AMD

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 Expanding Role of Vascular Endothelial Growth Factor Inhibitors in Ophthalmology

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