Session Title: Vascular Diseases I
Session Date/Time: Friday 27/09/2013 | 08:00-10:00
Paper Time: 08:48
Venue: Hall C (Level 1)
First Author: I.Pearce UK
Co Author(s): RELIGHT study group
In patients with visual impairment due to DMO (VI-DMO) treated with ranibizumab 0.5mg, the RELIGHT study investigates whether extending follow-up to bimonthly following initial monthly follow-up for 6 months, will provide and maintain improvements in vision.
RELIGHT is a UK based, prospective, open-label, multicenter, single-arm study.
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. Data is presented from the primary end-point at month-12.
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. This was achieved with a reduction in monitoring frequency, similar to that seen in year three of the DRCR.net study.