RT Journal Article
SR Electronic
T1 TANDEM TRIAL: a factorial randomised controlled trial of dose and review schedule of bevacizumab (<span class="underline">A</span>vastin) for neovascular macular degeneration in the <span class="underline">E</span>ast <span class="underline">M</span>idlands
JF BMJ Open Ophthalmology
JO BMJ Open Ophth
FD BMJ Publishing Group Ltd
SP e000588
DO 10.1136/bmjophth-2020-000588
VO 5
IS 1
A1 Alexander Foss
A1 Rebecca Haydock
A1 Margaret Childs
A1 Lelia M Duley
A1 Theo Empeslidis
A1 Sushma Dhar-Munshi
A1 Alan A Montgomery
A1 Reuben Ogollah
A1 Mara Ozolins
A1 Paul Tesha
A1 Eleanor Mitchell
YR 2020
UL http://bmjophth.bmj.com/content/5/1/e000588.abstract
AB Objective Neovascular age-related macular degeneration (nAMD) causes damage to the macula and severe vision loss. Bevacizumab is the most cost-effective nAMD treatment. The TANDEM trial was designed to determine whether, in patients with nAMD, low-dose bevacizumab is non-inferior to the standard dose in terms of visual deterioration and whether a bimonthly regimen is non-inferior to monthly, treatment as required, regimens.Methods This was a multicentre, 2×2 factorial, double-masked, non-inferiority randomised trial with patients considered eligible if they met the National Institute for Health and Care Excellence criteria for nAMD treatment with ranibizumab. Participants were randomly assigned to standard (1.25 mg) or low (0.625 mg) dose bevacizumab and either monthly or bimonthly review regimen. The primary outcome was time to vision deterioration, defined as reduction of ≥15 letters (three lines) during the loading phase (visual acuity scores at visits B and C compared with the initial visit A), or ≥6 letters (one line) during the maintenance phase (visual acuity scores at subsequent visits compared with mean vision at visits A–C).Results In total 812 participants (918 eyes) were randomised into the trial. The low dose showed some evidence of being non-inferior to standard dose (HR 1.07; 95% CI 0.80 to 1.42), however, there was no strong evidence of bimonthly review being non-inferior to monthly review (HR 1.45; 95% CI 1.09 to 1.94). There was no difference in visual acuity when assessed at 9 months and no major differences in the frequency of serious adverse events or reactions between the groups.Conclusion The standard dose of bevacizumab can be halved without compromising efficacy. Bimonthly review cannot be considered to be no worse than monthly review.