A randomised controlled Trial of high and low dose Avastin® for Neovascular macular Degeneration in the East Midlands (TANDEM)

ottingham University Hospitals NHS Trust (UK)0 个研究点目标入组 812 人开始时间: 2009年9月22日最近更新: 2020年6月8日

试验速览

•1. Adults of either sex aged 50 years and older
•2. Newly referred for the treatment of nAMD
•3. Corrected distance logarithm of the minimum angle of resolution visual acuity (VAlogMAR) greater than or equal to 20 letters and less than 70 letters read on a standard ETDRS chart at 1 metre
•4. Any component of the neovascular lesion (choroidal neovascularisation [CNV], blood, serous pigment epithelial detachment, elevated blocked fluorescence) involving the centre of the fovea

•1. Aged less than 50 years
•2. Corrected VAlogMAR less than 20 letters at 1 metre
•3. Long standing CNV evidenced by the presence of fibrosis in excess of 50% of the total lesion
•4. Greatest linear diameter greater than 6000 µm (equivalent to about 12 disc diameters)
•5. Argon laser treatment to the proposed study eye within the last 6 months
•6. Presence of thick blood involving the centre of the fovea
•7. Presence of other active ocular disease causing concurrent vision loss, e.g. diabetic retinopathy
•8. Previous treatment with photodynamic therapy (PDT) or a vascular endothelial growth factor (VEGF) inhibitor in either eye
•9. Patients with 8 or more diopters of myopia
•10. Pregnant and or lactating women
•11. Women with child bearing potential (i.e. not sterilised or not post-menopausal) who are unwilling to use contraception
•12. Men with a spouse or partner with child bearing potential unless the participant has agreed to use condoms
•13. Patients with known hypersensitivity to recombinant human or humanised antibodies

发起方

ottingham University Hospitals NHS Trust (UK)