Universität zu Köln

Heier, Jeffrey S., Brown, David M., Chong, Victor ORCID: 0000-0002-7693-522X, Korobelnik, Jean-Francois, Kaiser, Peter K., Kirchhof, Bernd, Ho, Allen, Ogura, Yuichiro, Yancopoulos, George D., Stahl, Neil, Vitti, Robert, Berliner, Alyson J., Soo, Yuhwen, Anderesi, Majid, Groetzbach, Georg, Sommerauer, Bernd, Sandbrink, Rupert, Simader, Christian ORCID: 0000-0002-1784-2883 and Schmidt-Erfurth, Ursula ORCID: 0000-0002-7788-7311 (2012). Intravitreal Aflibercept (VEGF Trap-Eye) in Wet Age-related Macular Degeneration. Ophthalmology, 119 (12). S. 2537 - 2549. NEW YORK: ELSEVIER SCIENCE INC. ISSN 0161-6420

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Abstract

Objective: Two similarly designed, phase-3 studies (VEGF Trap-Eye: Investigation of Efficacy and Safety in Wet AMD [VIEW 1, VIEW 2]) of neovascular age-related macular degeneration (AMD) compared monthly and every-2-month dosing of intravitreal aflibercept injection (VEGF Trap-Eye; Regeneron, Tarrytown, NY, and Bayer HealthCare, Berlin, Germany) with monthly ranibizumab. Design: Double-masked, multicenter, parallel-group, active-controlled, randomized trials. Participants: Patients (n = 2419) with active, subfoveal, choroidal neovascularization (CNV) lesions (or juxtafoveal lesions with leakage affecting the fovea) secondary to AMD. Intervention: Patients were randomized to intravitreal aflibercept 0.5 mg monthly (0.5q4), 2 mg monthly (2q4), 2 mg every 2 months after 3 initial monthly doses (2q8), or ranibizumab 0.5 mg monthly (Rq4). Main Outcome Measures: The primary end point was noninferiority (margin of 10%) of the aflibercept regimens to ranibizumab in the proportion of patients maintaining vision at week 52 (losing <15 letters on Early Treatment Diabetic Retinopathy Study [ETDRS] chart). Other key end points included change in best-corrected visual acuity (BCVA) and anatomic measures. Results: All aflibercept groups were noninferior and clinically equivalent to monthly ranibizumab for the primary end point (the 2q4, 0.5q4, and 2q8 regimens were 95.1%, 95.9%, and 95.1%, respectively, for VIEW 1, and 95.6%, 96.3%, and 95.6%, respectively, for VIEW 2, whereas monthly ranibizumab was 94.4% in both studies). In a prespecified integrated analysis of the 2 studies, all aflibercept regimens were within 0.5 letters of the reference ranibizumab for mean change in BCVA; all aflibercept regimens also produced similar improvements in anatomic measures. Ocular and systemic adverse events were similar across treatment groups. Conclusions: Intravitreal aflibercept dosed monthly or every 2 months after 3 initial monthly doses produced similar efficacy and safety outcomes as monthly ranibizumab. These studies demonstrate that aflibercept is an effective treatment for AMD, with the every-2-month regimen offering the potential to reduce the risk from monthly intravitreal injections and the burden of monthly monitoring. Financial Disclosure(s): Proprietary or commercial disclosure may be found after the references. Ophthalmology 2012;119:2537-2548 (C) 2012 by the American Academy of Ophthalmology.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Heier, Jeffrey S. UNSPECIFIED UNSPECIFIED UNSPECIFIED Brown, David M. UNSPECIFIED UNSPECIFIED UNSPECIFIED Chong, Victor UNSPECIFIED orcid.org/0000-0002-7693-522X UNSPECIFIED Korobelnik, Jean-Francois UNSPECIFIED UNSPECIFIED UNSPECIFIED Kaiser, Peter K. UNSPECIFIED UNSPECIFIED UNSPECIFIED Kirchhof, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Ho, Allen UNSPECIFIED UNSPECIFIED UNSPECIFIED Ogura, Yuichiro UNSPECIFIED UNSPECIFIED UNSPECIFIED Yancopoulos, George D. UNSPECIFIED UNSPECIFIED UNSPECIFIED Stahl, Neil UNSPECIFIED UNSPECIFIED UNSPECIFIED Vitti, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Berliner, Alyson J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Soo, Yuhwen UNSPECIFIED UNSPECIFIED UNSPECIFIED Anderesi, Majid UNSPECIFIED UNSPECIFIED UNSPECIFIED Groetzbach, Georg UNSPECIFIED UNSPECIFIED UNSPECIFIED Sommerauer, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Sandbrink, Rupert UNSPECIFIED UNSPECIFIED UNSPECIFIED Simader, Christian UNSPECIFIED orcid.org/0000-0002-1784-2883 UNSPECIFIED Schmidt-Erfurth, Ursula UNSPECIFIED orcid.org/0000-0002-7788-7311 UNSPECIFIED
URN:	urn:nbn:de:hbz:38-478183
DOI:	10.1016/j.ophtha.2012.09.006
Journal or Publication Title:	Ophthalmology
Volume:	119
Number:	12
Page Range:	S. 2537 - 2549
Date:	2012
Publisher:	ELSEVIER SCIENCE INC
Place of Publication:	NEW YORK
ISSN:	0161-6420
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language SUBFOVEAL CHOROIDAL NEOVASCULARIZATION; RANDOMIZED CLINICAL-TRIAL; PHOTODYNAMIC THERAPY; RANIBIZUMAB; VERTEPORFIN; GROWTH; LESIONS Multiple languages Ophthalmology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/47818