ISRCTN95654194
Completed
Phase 4
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 sites812 target enrollmentSeptember 22, 2009
Overview
- Phase
- Phase 4
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- ottingham University Hospitals NHS Trust (UK)
- Enrollment
- 812
- Status
- Completed
- Last Updated
- 5 years ago
Overview
Brief Summary
2015 protocol in: http://www.ncbi.nlm.nih.gov/pubmed/25873213
Investigators
Eligibility Criteria
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Outcomes
Primary Outcomes
Not specified
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