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The primary objective is to estimate the relative effectiveness of two VEGF inhibitors, Lucentis® (ranibizumab) and Avastin® (bevacizumab), on visual outcome in patients with CNV from AMD. Existing evidence of the benefit of VEGF inhibitors treatment precludes inclusion of a sham VEGF inhibition arm.
Other objectives are:
- To estimate the effectiveness of more frequent vs. less frequent VEGF inhibition in improving or maintaining visual function, with stringent criteria for restarting treatment to prevent visual acuity loss in patients receiving less frequent treatment.
- To estimate the cost-effectiveness of the alternative treatment strategies outlined above.
Inclusion criteria
- Adults of either sex aged 50 years and older;
- Newly referred for the treatment of nAMD in the first or second eye;
- Corrected distance logMAR visual acuity (VAlogMAR) ≥25 letters read on a standard ETDRS chart at 1 metre;
- Any component of the neovascular lesion (CNV, blood, serous pigment epithelial detachment, elevated blocked flourescence) involving the centre of the fovea. If a fellow eye develops CNV from AMD, it will be treated with the optimum locally available treatment.
Exclusion criteria
- Age less than 50 years
- Corrected VAlogMAR <25 letters at 1 metre;
- Long standing CNV evidenced by the presence of fibrosis in excess of 50% of the total lesion;
- Greatest linear diameter >6000μm (equivalent to about 12 disc diameters);
- Argon laser treatment to the proposed study eye within the last 6 months;
- Presence of thick blood involving the centre of the fovea;
- Presence of other active ocular disease causing concurrent vision loss, e.g. diabetic retinopathy;
- Previous treatment with PDT or a VEGF inhibitor in the eye being considered for inclusion;
- Pregnant and or lactating women;
- Women with child bearing potential (i.e. not sterilised or not post menopausal) who are unwilling to use contraception;
- Men with a spouse or partner with child bearing potential unless the participant has agreed to use condoms.
If you require any help, please contact:
Email: ivan-trial@bristol.ac.uk Telephone: +44 (0)117 928 3398
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