Literature DB >> 26069865

Optimizing the Anti-VEGF Treatment Strategy for Neovascular Age-Related Macular Degeneration: From Clinical Trials to Real-Life Requirements.

Irmela Mantel1.   

Abstract

This Perspective discusses the pertinence of variable dosing regimens with anti-vascular endothelial growth factor (VEGF) for neovascular age-related macular degeneration (nAMD) with regard to real-life requirements. After the initial pivotal trials of anti-VEGF therapy, the variable dosing regimens pro re nata (PRN), Treat-and-Extend, and Observe-and-Plan, a recently introduced regimen, aimed to optimize the anti-VEGF treatment strategy for nAMD. The PRN regimen showed good visual results but requires monthly monitoring visits and can therefore be difficult to implement. Moreover, application of the PRN regimen revealed inferior results in real-life circumstances due to problems with resource allocation. The Treat-and-Extend regimen uses an interval based approach and has become widely accepted for its ease of preplanning and the reduced number of office visits required. The parallel development of the Observe-and-Plan regimen demonstrated that the future need for retreatment (interval) could be reliably predicted. Studies investigating the observe-and-plan regimen also showed that this could be used in individualized fixed treatment plans, allowing for dramatically reduced clinical burden and good outcomes, thus meeting the real life requirements. This progressive development of variable dosing regimens is a response to the real-life circumstances of limited human, technical, and financial resources. This includes an individualized treatment approach, optimization of the number of retreatments, a minimal number of monitoring visits, and ease of planning ahead. The Observe-and-Plan regimen achieves this goal with good functional results. Translational Relevance: This perspective reviews the process from the pivotal clinical trials to the development of treatment regimens which are adjusted to real life requirements. The article discusses this translational process which- although not the classical interpretation of translation from fundamental to clinical research, but a subsequent process after the pivotal clinical trials - represents an important translational step from the clinical proof of efficacy to optimization in terms of patients' and clinics' needs. The related scientific procedure includes the exploration of the concept, evaluation of security, and finally proof of efficacy.

Entities:  

Keywords:  age-related macular degeneration; anti-VEGF treatment; real life; treatment outcome; variable dosing regimen

Year:  2015        PMID: 26069865      PMCID: PMC4461215          DOI: 10.1167/tvst.4.3.6

Source DB:  PubMed          Journal:  Transl Vis Sci Technol        ISSN: 2164-2591            Impact factor:   3.283


  20 in total

1.  Randomized, double-masked, sham-controlled trial of ranibizumab for neovascular age-related macular degeneration: PIER study year 2.

Authors:  Prema Abraham; Huibin Yue; Laura Wilson
Journal:  Am J Ophthalmol       Date:  2010-07-03       Impact factor: 5.258

2.  Prospective study evaluating the predictability of need for retreatment with intravitreal ranibizumab for age-related macular degeneration.

Authors:  Irmela Mantel; Angeliki Deli; Katia Iglesias; Aude Ambresin
Journal:  Graefes Arch Clin Exp Ophthalmol       Date:  2012-06-26       Impact factor: 3.117

3.  Ranibizumab versus verteporfin for neovascular age-related macular degeneration.

Authors:  David M Brown; Peter K Kaiser; Mark Michels; Gisele Soubrane; Jeffrey S Heier; Robert Y Kim; Judy P Sy; Susan Schneider
Journal:  N Engl J Med       Date:  2006-10-05       Impact factor: 91.245

4.  Efficacy and safety of monthly versus quarterly ranibizumab treatment in neovascular age-related macular degeneration: the EXCITE study.

Authors:  Ursula Schmidt-Erfurth; Bora Eldem; Robyn Guymer; Jean-François Korobelnik; Reinier O Schlingemann; Ruth Axer-Siegel; Peter Wiedemann; Christian Simader; Margarita Gekkieva; Andreas Weichselberger
Journal:  Ophthalmology       Date:  2010-12-13       Impact factor: 12.079

5.  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.

Authors:  C Gianniou; A Dirani; W Ferrini; L Marchionno; D Decugis; A Deli; A Ambresin; I Mantel
Journal:  Eye (Lond)       Date:  2014-11-07       Impact factor: 3.775

6.  The neovascular age-related macular degeneration database: multicenter study of 92 976 ranibizumab injections: report 1: visual acuity.

Authors: 
Journal:  Ophthalmology       Date:  2014-01-23       Impact factor: 12.079

7.  Twelve-month efficacy and safety of 0.5 mg or 2.0 mg ranibizumab in patients with subfoveal neovascular age-related macular degeneration.

Authors:  Brandon G Busbee; Allen C Ho; David M Brown; Jeffrey S Heier; Ivan J Suñer; Zhengrong Li; Roman G Rubio; Phillip Lai
Journal:  Ophthalmology       Date:  2013-01-23       Impact factor: 12.079

8.  Functional and anatomical outcome of eyes with neovascular age-related macular degeneration treated with intravitreal ranibizumab following an exit strategy regimen.

Authors:  Marcel N Menke; Martin S Zinkernagel; Andreas Ebneter; Sebastian Wolf
Journal:  Br J Ophthalmol       Date:  2014-04-29       Impact factor: 4.638

9.  Efficacy of treatment with ranibizumab in patients with wet age-related macular degeneration in routine clinical care: data from the COMPASS health services research.

Authors:  Armin Wolf; Anselm Kampik
Journal:  Graefes Arch Clin Exp Ophthalmol       Date:  2014-01-15       Impact factor: 3.117

10.  Ranibizumab versus bevacizumab to treat neovascular age-related macular degeneration: one-year findings from the IVAN randomized trial.

Authors:  Usha Chakravarthy; Simon P Harding; Chris A Rogers; Susan M Downes; Andrew J Lotery; Sarah Wordsworth; Barnaby C Reeves
Journal:  Ophthalmology       Date:  2012-05-11       Impact factor: 12.079

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  18 in total

1.  Two-year results of a treat-and-extend regimen with aflibercept for polypoidal choroidal vasculopathy.

Authors:  Masahiro Morimoto; Hidetaka Matsumoto; Kensuke Mimura; Hideo Akiyama
Journal:  Graefes Arch Clin Exp Ophthalmol       Date:  2017-07-01       Impact factor: 3.117

Review 2.  Vascular endothelial growth factor: a neurovascular target in neurological diseases.

Authors:  Christian Lange; Erik Storkebaum; Carmen Ruiz de Almodóvar; Mieke Dewerchin; Peter Carmeliet
Journal:  Nat Rev Neurol       Date:  2016-07-01       Impact factor: 42.937

3.  Stereotactic radiotherapy in neovascular age-related macular degeneration: Real-life efficacy and morphological evaluation of the outer retina-choroid complex.

Authors:  Mahdy Ranjbar; Maximilian Kurz; Annekatrin Holzhey; Corinna Melchert; Dirk Rades; Salvatore Grisanti
Journal:  Medicine (Baltimore)       Date:  2016-12       Impact factor: 1.889

4.  Treatment of age-related neovascular macular degeneration: the patient's perspective.

Authors:  S Müller; C Ehlken; U Bauer-Steinhusen; W Lechtenfeld; Z Hasanbasic; H Agostini; T Wilke
Journal:  Graefes Arch Clin Exp Ophthalmol       Date:  2017-08-04       Impact factor: 3.117

5.  Two-year outcome of an observe-and-plan regimen for neovascular age-related macular degeneration treated with Aflibercept.

Authors:  Parmis Parvin; Marta Zola; Ali Dirani; Aude Ambresin; Irmela Mantel
Journal:  Graefes Arch Clin Exp Ophthalmol       Date:  2017-08-10       Impact factor: 3.117

6.  Subfoveal choriocapillaris, Sattler's and Haller's layer thickness predict clinical response to stereotactic radiotherapy in neovascular age-related macular degeneration patients.

Authors:  Mahdy Ranjbar; Michelle Prasuhn; Maximilian Kurz; Annekatrin Holzhey; Felix Rommel; Max Philipp Brinkmann; Dirk Rades; Salvatore Grisanti
Journal:  J Curr Ophthalmol       Date:  2019-01-02

Review 7.  Recent developments in age-related macular degeneration: a review.

Authors:  Waseem M Al-Zamil; Sanaa A Yassin
Journal:  Clin Interv Aging       Date:  2017-08-22       Impact factor: 4.458

8.  Outcome of 5-Year Treatment of Neovascular Age-Related Macular Degeneration With Intravitreal Anti-VEGF Using "Treat and Extend" Regimen.

Authors:  Polona Jaki Mekjavic; Polona Zaletel Benda
Journal:  Front Med (Lausanne)       Date:  2018-05-01

9.  REAL-WORLD EFFECTIVENESS AND SAFETY OF RANIBIZUMAB TREATMENT IN PATIENTS WITH AND WITHOUT POLYPOIDAL CHOROIDAL VASCULOPATHY: Twelve-Month Results From the LUMINOUS Study.

Authors:  Adrian Koh; Timothy Y Y Lai; Wen Bin Wei; Ryusaburo Mori; Harumi Wakiyama; Kyu Hyung Park; Fariza Ngah; Wayne Macfadden; Cornelia Dunger-Baldauf; Soumil Parikh
Journal:  Retina       Date:  2020-08       Impact factor: 3.975

10.  Management of Wet Age-Related Macular Degeneration in Spain: Challenges for Treat and Extend Implementation in Routine Clinical Practice.

Authors:  A García-Layana; J García-Arumí; M S Figueroa; L Arias Barquet; J M Ruíz-Moreno; L Monclús-Arbona
Journal:  J Ophthalmol       Date:  2019-09-30       Impact factor: 1.909

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