The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing

Jeffrey S. Heier, David Boyer, Quan Dong Nguyen, Dennis Marcus, Daniel B. Roth, George Yancopoulos, Neil Stahl, Avner Ingerman, Robert Vitti, Alyson J. Berliner, Ke Yang, David M. Brown

Research output: Contribution to journalArticle

Abstract

Objective: To evaluate anatomic outcomes and vision, injection frequency, and safety during the as-needed (PRN) treatment phase of a study evaluating a 12-week fixed dosing period followed by PRN dosing to week 52 with vascular endothelial growth factor (VEGF) Trap-Eye for neovascular (wet) age-related macular degeneration (AMD). Design: Multicenter, randomized, double-masked trial. Participants: We included 159 patients with subfoveal choroidal neovascularization (CNV) secondary to wet AMD. Methods: Patients were randomly assigned to 1 of 5 intravitreal VEGF Trap-Eye treatment groups: 0.5 mg or 2 mg every 4 weeks or 0.5, 2, or 4 mg every 12 weeks during the fixed-dosing period (weeks 1-12). From weeks 16 to 52, patients were evaluated monthly and were retreated PRN with their assigned dose (0.5, 2, or 4 mg). Main Outcome Measures: Change in central retinal/lesion thickness (CR/LT), change in total lesion and CNV size, mean change in best-corrected visual acuity (BCVA), proportion of patients with 15-letter loss or gain, time to first PRN injection, reinjection frequency, and safety at week 52. Results: The decrease in CR/LT at week 12 versus baseline remained significant at weeks 12 to 52 (-130 μm from baseline at week 52) and CNV size regressed from baseline by 2.21 mm2 at 48 weeks. After achieving a significant improvement in BCVA during the 12-week, fixed-dosing phase for all groups combined, PRN dosing for 40 weeks maintained improvements in BCVA to 52 weeks (5.3-letter gain; P

Original languageEnglish (US)
Pages (from-to)1098-1106
Number of pages9
JournalOphthalmology
Volume118
Issue number6
DOIs
StatePublished - Jun 2011

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Choroidal Neovascularization
Vascular Endothelial Growth Factor A
Visual Acuity
Macular Degeneration
Safety
Injections
Outcome Assessment (Health Care)
Therapeutics

ASJC Scopus subject areas

  • Ophthalmology

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The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. / Heier, Jeffrey S.; Boyer, David; Nguyen, Quan Dong; Marcus, Dennis; Roth, Daniel B.; Yancopoulos, George; Stahl, Neil; Ingerman, Avner; Vitti, Robert; Berliner, Alyson J.; Yang, Ke; Brown, David M.

In: Ophthalmology, Vol. 118, No. 6, 06.2011, p. 1098-1106.

Research output: Contribution to journalArticle

Heier, JS, Boyer, D, Nguyen, QD, Marcus, D, Roth, DB, Yancopoulos, G, Stahl, N, Ingerman, A, Vitti, R, Berliner, AJ, Yang, K & Brown, DM 2011, 'The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing', Ophthalmology, vol. 118, no. 6, pp. 1098-1106. https://doi.org/10.1016/j.ophtha.2011.03.020
Heier, Jeffrey S. ; Boyer, David ; Nguyen, Quan Dong ; Marcus, Dennis ; Roth, Daniel B. ; Yancopoulos, George ; Stahl, Neil ; Ingerman, Avner ; Vitti, Robert ; Berliner, Alyson J. ; Yang, Ke ; Brown, David M. / The 1-year results of CLEAR-IT 2, a phase 2 study of vascular endothelial growth factor trap-eye dosed as-needed after 12-week fixed dosing. In: Ophthalmology. 2011 ; Vol. 118, No. 6. pp. 1098-1106.
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AU - Heier, Jeffrey S.

AU - Boyer, David

AU - Nguyen, Quan Dong

AU - Marcus, Dennis

AU - Roth, Daniel B.

AU - Yancopoulos, George

AU - Stahl, Neil

AU - Ingerman, Avner

AU - Vitti, Robert

AU - Berliner, Alyson J.

AU - Yang, Ke

AU - Brown, David M.

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N2 - Objective: To evaluate anatomic outcomes and vision, injection frequency, and safety during the as-needed (PRN) treatment phase of a study evaluating a 12-week fixed dosing period followed by PRN dosing to week 52 with vascular endothelial growth factor (VEGF) Trap-Eye for neovascular (wet) age-related macular degeneration (AMD). Design: Multicenter, randomized, double-masked trial. Participants: We included 159 patients with subfoveal choroidal neovascularization (CNV) secondary to wet AMD. Methods: Patients were randomly assigned to 1 of 5 intravitreal VEGF Trap-Eye treatment groups: 0.5 mg or 2 mg every 4 weeks or 0.5, 2, or 4 mg every 12 weeks during the fixed-dosing period (weeks 1-12). From weeks 16 to 52, patients were evaluated monthly and were retreated PRN with their assigned dose (0.5, 2, or 4 mg). Main Outcome Measures: Change in central retinal/lesion thickness (CR/LT), change in total lesion and CNV size, mean change in best-corrected visual acuity (BCVA), proportion of patients with 15-letter loss or gain, time to first PRN injection, reinjection frequency, and safety at week 52. Results: The decrease in CR/LT at week 12 versus baseline remained significant at weeks 12 to 52 (-130 μm from baseline at week 52) and CNV size regressed from baseline by 2.21 mm2 at 48 weeks. After achieving a significant improvement in BCVA during the 12-week, fixed-dosing phase for all groups combined, PRN dosing for 40 weeks maintained improvements in BCVA to 52 weeks (5.3-letter gain; P

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