Purchase this article with an account.
J. S. Slakter, CLEAR-IT 2 Study Group; Influence of Baseline Angiographic Classification on Outcomes in the CLEAR-IT 2 Phase 2 Study of Intravitreal VEGF Trap-Eye in Neovascular Age-Related Macular Degeneration. Invest. Ophthalmol. Vis. Sci. 2010;51(13):2055.
Download citation file:
© ARVO (1962-2015); The Authors (2016-present)
To determine if treatment outcomes for patients enrolled in the CLEAR-IT 2 study of VEGF Trap-Eye in patients with neovascular AMD were influenced by baseline fluorescein angiographic characteristics, including the presence of cystoid macular edema (CME), retinal angiomatous proliferation (RAP), and serous pigment epithelial detachments (PEDs).
CLEAR-IT 2 was a randomized, multicenter, prospective dose and dose-interval ranging study designed to assess the safety and efficacy of VEGF Trap-Eye in patients with subfoveal choroidal neovascularization secondary to AMD. Patients with neovascular AMD (n=157) received VEGF Trap-Eye 0.5 or 2.0 mg monthly or 0.5, 2.0, or 4.0 mg quarterly for 12 weeks, followed by PRN dosing to 1 year. Anatomic efficacy measures were assessed using optical coherence tomography (OCT) and fluorescein angiography (FA). All OCT and FA images were assessed by central reading centers. A subanalyis was performed for patients who entered the study with CME (n=12), RAP lesions (n=7), and serous PED (n=10).
For all groups combined (n=157), mean change in visual acuity from baseline at 1 year was 5.3 letters (p<0.0001) with 63 of the 157 patients (40%) gaining 2 or more lines. The mean change in central retinal/lesion thickness from baseline was -130µm (p< 0.0001) at 1 year. For patients with RAP lesions at baseline, mean change in visual acuity at week 52 was + 6.3 letters, with 4 of the 7 patients gaining 2 or more lines. For patients with CME at baseline, mean change in visual acuity at week 52 was +12 letters with 8 of the 12 patients gaining 2 or more lines. For patients with serous PED at baseline, mean change in visual acuity at week 52 was +6.7 letters, with 5 of the 10 patients gaining 3 or more lines.
VEGF Trap-Eye produced significant improvements in visual acuity in patients with CME, RAP lesions, and serous PEDs similar to those seen with the overall patient population.
Clinical Trial: :
This PDF is available to Subscribers Only