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D. V. Do, CLEAR-IT 2 Investigators; VEGF Trap-Eye Vision-Specific Quality of Life Through 52 Weeks in Patients With Neovascular AMD in CLEAR-IT 2: A Phase 2 Clinical Trial. Invest. Ophthalmol. Vis. Sci. 2009;50(13):1887.
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To examine the effects of VEGF Trap-Eye on patient-reported vision-specific Quality of Life (QoL) using the National Eye Institute Visual Function Questionnaire (NEI VFQ-25) in CLEAR-IT 2: a Phase 2 randomized trial in patients with subfoveal choroidal neovascularization (CNV) due to AMD.
CLEAR-IT 2 was a randomized, double masked, multi-center Phase 2 trial. Patients received intravitreal injections of 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 based on results of OCT and clinical examination out to 52 weeks. The NEI-VFQ 25 was administered to patients at baseline, week 12, and week 52. QoL was assessed at 52 weeks by change in mean score from baseline. The NEI-VFQ 25 subscales are scored from 0-100; a positive difference represents improved functioning or reduced dependency. Pre-specified subscales included near activities, distance activities, and vision related dependency.
The mean overall change from baseline to 52 weeks in the total score of the NEI-VFQ 25 for all treatment groups combined (n=145) was +4.5. For all groups combined patients had mean changes of +5.7 for near activities, +3.4 for distance activities and +5.8 for vision related dependency. Patients receiving the 2.0 mg dose monthly for the first 12 weeks (2mg q4 group, n=28) had a change from baseline of +4.5 in the total score, +6.8 for near activities, +4.6 for distance activities, and +11.6 for vision related dependency at 52 weeks.
Patients treated with multiple doses of VEGF Trap-Eye over a 52 week period had overall improvements in the patient-reported vision-specific QoL (total scores as well as subscales) as assessed by the NEI-VFQ 25. As a clinically meaningful change is often considered to be ±5 points, the most notable improvements were seen in the 2mg q4 group for near activities and for vision related dependency.
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