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Clinical Trials/ISRCTN95654194
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

Registry
who.int
Start Date
September 22, 2009
End Date
March 31, 2017
Last Updated
5 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
ottingham University Hospitals NHS Trust (UK)

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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