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Ian Pearce, RELIGHT STUDY GROUP; RELIGHT - Ranibizumab treatment of diabetic macular oedema with bimonthly monitoring after a phase of initial Treatment. Invest. Ophthalmol. Vis. Sci. 2013;54(15):4029. doi: https://doi.org/.
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© ARVO (1962-2015); The Authors (2016-present)
In patients with visual impairment due to DME (VI-DME) treated with ranibizumab 0.5mg, the 18-month RELIGHT study investigates whether extending follow-up intervals to bimonthly following initial monthly follow-up for 6 months, will provide and maintain improvements in vision. Data is presented from the primary end-point at month-12.
This is a prospective, open-label, multicenter, single-arm study. It evaluates three monthly initiation doses of ranibizumab 0.5mg, followed by individualised retreatment. Retreatment criteria are based on reductions in VA of >5 letters and / or OCT ≥225 micrometers with monthly review for three months following initiation, and subsequent bi-monthly review out to 18 months. Laser treatment was permitted after 6 months.
Of 139 patients screened, 110 initiated treatment, The primary endpoint was reached for the last patient in October 2012. Preliminary analyses show at baseline, patients had a median age 64 (range 37.5 to 82), median HbA1c 7.6% (range 5.4 to 11.7), and mean BP 139/78 mmHg. Median VA improved from 65 letters (6/15) (range 34 to 84) at baseline to 70 letters (6/12) (range 3 to 85), a median change of 5 letters (range -51 to 27) at 12-months. Median central subfield thickness improved from 452.5µm to 293 µm, representing a median change of -127.5µm. A median of seven (range 3-9) injections were given, with 23.1% of patients achieving ≥10 letter gain and 4.6% demonstrating ≥10 letter loss.
This regimen provided VA gains and central subfield thickness improvements consistent with those in the pivotal RESTORE and DRCR.net studies. The reduction in monitoring frequency in RELIGHT supports that seen in year three of the DRCR.net study in which there was a median of 7 to 8 appointments, with at least 25% of patients being reviewed on the protocol mandated minimum of 4 occasions, while maintaining vision with a median of 1 to 2 injections.
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