Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration

To evaluate the biologic effects and safety of vascular endothelial growth factor (VEGF) Trap-Eye during a 12-week fixed-dosing period in patients with neovascular (wet) age-related macular degeneration (AMD). Multicenter, prospective, randomized, double-masked clinical trial with initial 12-week fi...

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Published in:	Ophthalmology (Rochester, Minn.) Vol. 118; no. 6; p. 1089
Main Authors:	Brown, David M, Heier, Jeffrey S, Ciulla, Thomas, Benz, Matthew, Abraham, Prema, Yancopoulos, George, Stahl, Neil, Ingerman, Avner, Vitti, Robert, Berliner, Alyson J, Yang, Ke, Nguyen, Quan Dong
Format:	Journal Article
Language:	English
Published:	United States 01.06.2011
Subjects:	Aged Aged, 80 and over Choroidal Neovascularization - diagnosis Choroidal Neovascularization - etiology Choroidal Neovascularization - prevention & control Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Follow-Up Studies Fovea Centralis - drug effects Fovea Centralis - pathology Humans Intravitreal Injections Male Middle Aged Prospective Studies Treatment Outcome Vascular Endothelial Growth Factor A - administration & dosage Vascular Endothelial Growth Factor A - therapeutic use Visual Acuity Wet Macular Degeneration - complications Wet Macular Degeneration - diagnosis Wet Macular Degeneration - drug therapy
ISSN:	1549-4713, 1549-4713
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Abstract	To evaluate the biologic effects and safety of vascular endothelial growth factor (VEGF) Trap-Eye during a 12-week fixed-dosing period in patients with neovascular (wet) age-related macular degeneration (AMD). Multicenter, prospective, randomized, double-masked clinical trial with initial 12-week fixed dosing period. Data were analyzed to week 16. We included 159 patients with subfoveal choroidal neovascularization secondary to wet AMD. Patients were randomized 1:1:1:1:1 to VEGF Trap-Eye during the fixed-dosing phase (day 1 to week 12): 0.5 or 2 mg every 4 weeks (0.5 mg q4wk, 2 mg q4wk) on day 1 and at weeks 4, 8, and 12; or 0.5, 2, or 4 mg every 12 weeks (0.5 mg q12wk, 2 mg q12wk, or 4 mg q12wk) on day 1 and at week 12. The primary endpoint was change from baseline in central retinal/lesion thickness (CR/LT) at week 12; secondary outcomes included change in best-corrected visual acuity (BCVA), proportion of patients with a gain of ≥ 15 letters, proportion of patients with a loss of >15 letters, and safety. At week 12, treatment with VEGF Trap-Eye resulted in a significant mean decrease in CR/LT of 119 μm from baseline in all groups combined (P<0.0001). The reduction in CR/LT with the 2 mg q4wk and 0.5mg q4wk regimens was significantly greater than each of the quarterly dosing regimens. The BCVA increased significantly by a mean of 5.7 letters at 12 weeks in the combined group (P<0.0001), with the greatest mean gain of >8 letters in the monthly dosing groups. At 8 weeks, BCVA improvements were similar with 2 mg q4wk and 2 mg q12wk dosing. After the last required dose at week 12, CR/LT and visual acuity were maintained or further improved at week 16 in all treatment groups. Ocular adverse events were mild and consistent with safety profiles reported for other intraocular anti-VEGF treatments. Repeated monthly intravitreal dosing of VEGF Trap-Eye over 12 weeks demonstrated significant reductions in retinal thickness and improvements in visual acuity, and was well-tolerated in patients with neovascular AMD. Proprietary or commercial disclosure may be found after the references.
AbstractList	To evaluate the biologic effects and safety of vascular endothelial growth factor (VEGF) Trap-Eye during a 12-week fixed-dosing period in patients with neovascular (wet) age-related macular degeneration (AMD).OBJECTIVETo evaluate the biologic effects and safety of vascular endothelial growth factor (VEGF) Trap-Eye during a 12-week fixed-dosing period in patients with neovascular (wet) age-related macular degeneration (AMD).Multicenter, prospective, randomized, double-masked clinical trial with initial 12-week fixed dosing period. Data were analyzed to week 16.DESIGNMulticenter, prospective, randomized, double-masked clinical trial with initial 12-week fixed dosing period. Data were analyzed to week 16.We included 159 patients with subfoveal choroidal neovascularization secondary to wet AMD.PARTICIPANTSWe included 159 patients with subfoveal choroidal neovascularization secondary to wet AMD.Patients were randomized 1:1:1:1:1 to VEGF Trap-Eye during the fixed-dosing phase (day 1 to week 12): 0.5 or 2 mg every 4 weeks (0.5 mg q4wk, 2 mg q4wk) on day 1 and at weeks 4, 8, and 12; or 0.5, 2, or 4 mg every 12 weeks (0.5 mg q12wk, 2 mg q12wk, or 4 mg q12wk) on day 1 and at week 12.METHODSPatients were randomized 1:1:1:1:1 to VEGF Trap-Eye during the fixed-dosing phase (day 1 to week 12): 0.5 or 2 mg every 4 weeks (0.5 mg q4wk, 2 mg q4wk) on day 1 and at weeks 4, 8, and 12; or 0.5, 2, or 4 mg every 12 weeks (0.5 mg q12wk, 2 mg q12wk, or 4 mg q12wk) on day 1 and at week 12.The primary endpoint was change from baseline in central retinal/lesion thickness (CR/LT) at week 12; secondary outcomes included change in best-corrected visual acuity (BCVA), proportion of patients with a gain of ≥ 15 letters, proportion of patients with a loss of >15 letters, and safety.MAIN OUTCOME MEASURESThe primary endpoint was change from baseline in central retinal/lesion thickness (CR/LT) at week 12; secondary outcomes included change in best-corrected visual acuity (BCVA), proportion of patients with a gain of ≥ 15 letters, proportion of patients with a loss of >15 letters, and safety.At week 12, treatment with VEGF Trap-Eye resulted in a significant mean decrease in CR/LT of 119 μm from baseline in all groups combined (P<0.0001). The reduction in CR/LT with the 2 mg q4wk and 0.5mg q4wk regimens was significantly greater than each of the quarterly dosing regimens. The BCVA increased significantly by a mean of 5.7 letters at 12 weeks in the combined group (P<0.0001), with the greatest mean gain of >8 letters in the monthly dosing groups. At 8 weeks, BCVA improvements were similar with 2 mg q4wk and 2 mg q12wk dosing. After the last required dose at week 12, CR/LT and visual acuity were maintained or further improved at week 16 in all treatment groups. Ocular adverse events were mild and consistent with safety profiles reported for other intraocular anti-VEGF treatments.RESULTSAt week 12, treatment with VEGF Trap-Eye resulted in a significant mean decrease in CR/LT of 119 μm from baseline in all groups combined (P<0.0001). The reduction in CR/LT with the 2 mg q4wk and 0.5mg q4wk regimens was significantly greater than each of the quarterly dosing regimens. The BCVA increased significantly by a mean of 5.7 letters at 12 weeks in the combined group (P<0.0001), with the greatest mean gain of >8 letters in the monthly dosing groups. At 8 weeks, BCVA improvements were similar with 2 mg q4wk and 2 mg q12wk dosing. After the last required dose at week 12, CR/LT and visual acuity were maintained or further improved at week 16 in all treatment groups. Ocular adverse events were mild and consistent with safety profiles reported for other intraocular anti-VEGF treatments.Repeated monthly intravitreal dosing of VEGF Trap-Eye over 12 weeks demonstrated significant reductions in retinal thickness and improvements in visual acuity, and was well-tolerated in patients with neovascular AMD.CONCLUSIONSRepeated monthly intravitreal dosing of VEGF Trap-Eye over 12 weeks demonstrated significant reductions in retinal thickness and improvements in visual acuity, and was well-tolerated in patients with neovascular AMD.Proprietary or commercial disclosure may be found after the references.FINANCIAL DISCLOSURE(S)Proprietary or commercial disclosure may be found after the references. To evaluate the biologic effects and safety of vascular endothelial growth factor (VEGF) Trap-Eye during a 12-week fixed-dosing period in patients with neovascular (wet) age-related macular degeneration (AMD). Multicenter, prospective, randomized, double-masked clinical trial with initial 12-week fixed dosing period. Data were analyzed to week 16. We included 159 patients with subfoveal choroidal neovascularization secondary to wet AMD. Patients were randomized 1:1:1:1:1 to VEGF Trap-Eye during the fixed-dosing phase (day 1 to week 12): 0.5 or 2 mg every 4 weeks (0.5 mg q4wk, 2 mg q4wk) on day 1 and at weeks 4, 8, and 12; or 0.5, 2, or 4 mg every 12 weeks (0.5 mg q12wk, 2 mg q12wk, or 4 mg q12wk) on day 1 and at week 12. The primary endpoint was change from baseline in central retinal/lesion thickness (CR/LT) at week 12; secondary outcomes included change in best-corrected visual acuity (BCVA), proportion of patients with a gain of ≥ 15 letters, proportion of patients with a loss of >15 letters, and safety. At week 12, treatment with VEGF Trap-Eye resulted in a significant mean decrease in CR/LT of 119 μm from baseline in all groups combined (P<0.0001). The reduction in CR/LT with the 2 mg q4wk and 0.5mg q4wk regimens was significantly greater than each of the quarterly dosing regimens. The BCVA increased significantly by a mean of 5.7 letters at 12 weeks in the combined group (P<0.0001), with the greatest mean gain of >8 letters in the monthly dosing groups. At 8 weeks, BCVA improvements were similar with 2 mg q4wk and 2 mg q12wk dosing. After the last required dose at week 12, CR/LT and visual acuity were maintained or further improved at week 16 in all treatment groups. Ocular adverse events were mild and consistent with safety profiles reported for other intraocular anti-VEGF treatments. Repeated monthly intravitreal dosing of VEGF Trap-Eye over 12 weeks demonstrated significant reductions in retinal thickness and improvements in visual acuity, and was well-tolerated in patients with neovascular AMD. Proprietary or commercial disclosure may be found after the references.
Author	Stahl, Neil Vitti, Robert Yancopoulos, George Ciulla, Thomas Abraham, Prema Yang, Ke Brown, David M Heier, Jeffrey S Ingerman, Avner Berliner, Alyson J Benz, Matthew Nguyen, Quan Dong
Author_xml	– sequence: 1 givenname: David M surname: Brown fullname: Brown, David M email: dmbmd@houstonretina.com organization: Retina Consultants of Houston, The Methodist Hospital, Houston, Texas, USA. dmbmd@houstonretina.com – sequence: 2 givenname: Jeffrey S surname: Heier fullname: Heier, Jeffrey S – sequence: 3 givenname: Thomas surname: Ciulla fullname: Ciulla, Thomas – sequence: 4 givenname: Matthew surname: Benz fullname: Benz, Matthew – sequence: 5 givenname: Prema surname: Abraham fullname: Abraham, Prema – sequence: 6 givenname: George surname: Yancopoulos fullname: Yancopoulos, George – sequence: 7 givenname: Neil surname: Stahl fullname: Stahl, Neil – sequence: 8 givenname: Avner surname: Ingerman fullname: Ingerman, Avner – sequence: 9 givenname: Robert surname: Vitti fullname: Vitti, Robert – sequence: 10 givenname: Alyson J surname: Berliner fullname: Berliner, Alyson J – sequence: 11 givenname: Ke surname: Yang fullname: Yang, Ke – sequence: 12 givenname: Quan Dong surname: Nguyen fullname: Nguyen, Quan Dong
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Copyright	Copyright © 2011 American Academy of Ophthalmology. Published by Elsevier Inc. All rights reserved.
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SubjectTerms	Aged Aged, 80 and over Choroidal Neovascularization - diagnosis Choroidal Neovascularization - etiology Choroidal Neovascularization - prevention & control Dose-Response Relationship, Drug Double-Blind Method Drug Administration Schedule Female Follow-Up Studies Fovea Centralis - drug effects Fovea Centralis - pathology Humans Intravitreal Injections Male Middle Aged Prospective Studies Treatment Outcome Vascular Endothelial Growth Factor A - administration & dosage Vascular Endothelial Growth Factor A - therapeutic use Visual Acuity Wet Macular Degeneration - complications Wet Macular Degeneration - diagnosis Wet Macular Degeneration - drug therapy
Title	Primary endpoint results of a phase II study of vascular endothelial growth factor trap-eye in wet age-related macular degeneration
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