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
JS Heier, D Boyer, QD Nguyen, D Marcus, DB Roth… - Ophthalmology, 2011 - Elsevier
JS Heier, D Boyer, QD Nguyen, D Marcus, DB Roth, G Yancopoulos, N Stahl, A Ingerman…
Ophthalmology, 2011•ElsevierObjective 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 …
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 …
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<0.0001). The most robust improvements and consistent maintenance of visual acuity generally occurred in patients initially dosed with 2 mg every 4 weeks for 12 weeks, demonstrating a gain of 9 letters at 52 weeks. Overall, a mean of 2 injections was administered after the 12-week fixed-dosing phase, and the mean time to first reinjection was 129 days; 19% of patients received no injections and 45% received 1 or 2 injections. Treatment with VEGF Trap-Eye was generally safe and well tolerated, with few ocular or systemic adverse events.
Conclusions
PRN dosing with VEGF Trap-Eye at weeks 16-52 maintained the significant anatomic and vision improvements established during the 12-week fixed-dosing phase with a low frequency of reinjections. Repeated dosing with VEGF Trap-Eye was well tolerated over 52 weeks of treatment.
Financial Disclosure(s)
Proprietary or commercial disclosure may be found after the references.
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