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Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration.
Ophthalmology 2012; 119(12):2537-48O

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.

Authors+Show Affiliations

Ophthalmic Consultants of Boston and Tufts University School of Medicine, Boston, Massachusetts, USA.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial, Phase III
Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23084240

Citation

Heier, Jeffrey S., et al. "Intravitreal Aflibercept (VEGF Trap-eye) in Wet Age-related Macular Degeneration." Ophthalmology, vol. 119, no. 12, 2012, pp. 2537-48.
Heier JS, Brown DM, Chong V, et al. Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology. 2012;119(12):2537-48.
Heier, J. S., Brown, D. M., Chong, V., Korobelnik, J. F., Kaiser, P. K., Nguyen, Q. D., ... Schmidt-Erfurth, U. (2012). Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. Ophthalmology, 119(12), pp. 2537-48. doi:10.1016/j.ophtha.2012.09.006.
Heier JS, et al. Intravitreal Aflibercept (VEGF Trap-eye) in Wet Age-related Macular Degeneration. Ophthalmology. 2012;119(12):2537-48. PubMed PMID: 23084240.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Intravitreal aflibercept (VEGF trap-eye) in wet age-related macular degeneration. AU - Heier,Jeffrey S, AU - Brown,David M, AU - Chong,Victor, AU - Korobelnik,Jean-Francois, AU - Kaiser,Peter K, AU - Nguyen,Quan Dong, AU - Kirchhof,Bernd, AU - Ho,Allen, AU - Ogura,Yuichiro, AU - Yancopoulos,George D, AU - Stahl,Neil, AU - Vitti,Robert, AU - Berliner,Alyson J, AU - Soo,Yuhwen, AU - Anderesi,Majid, AU - Groetzbach,Georg, AU - Sommerauer,Bernd, AU - Sandbrink,Rupert, AU - Simader,Christian, AU - Schmidt-Erfurth,Ursula, AU - ,, Y1 - 2012/10/17/ PY - 2012/07/26/received PY - 2012/08/30/revised PY - 2012/09/04/accepted PY - 2012/10/23/entrez PY - 2012/10/23/pubmed PY - 2013/2/8/medline SP - 2537 EP - 48 JF - Ophthalmology JO - Ophthalmology VL - 119 IS - 12 N2 - 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. SN - 1549-4713 UR - https://www.unboundmedicine.com/medline/citation/23084240/Intravitreal_aflibercept__VEGF_trap_eye__in_wet_age_related_macular_degeneration_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0161-6420(12)00865-2 DB - PRIME DP - Unbound Medicine ER -