The monoclonal antibody Lucentis (ranibizumab) is now indicated for the treatment of visual impairment due to diabetic macular oedema. It is given as a single 500 microgram intravitreal injection monthly until maximum visual acuity is achieved (ie measurements remain stable for at least three consecutive months).
The efficacy and safety of ranibizumab in this setting was assessed in two randomised, controlled, double-blind studies of 12 months duration. A total of 496 patients were enrolled, the majority of whom had type II diabetes; 28 of those treated with ranibizumab had type I diabetes.
The phase II study (RESOLVE, n=151) demonstrated a significantly improved best-corrected visual acuity (BCVA) for ranibizumab compared with sham treatment (+10.3 letters vs –1.4 letters; p<0.0001). In the phase III study (RESTORE, n=345), mean average change in BCVA was significantly greater in patients treated with ranibizumab as monotherapy (+6.1 letters) or as an adjunct to laser photocoagulation (+5.9 letters) than in those who underwent laser treatment only (+0.8 letters; p<0.0001 for both comparisons). There was no relevant difference between the efficacy of ranibizumab when used as monotherapy and when used alongside laser treatment.
Lucentis was previously licensed only for neovascular (wet) age-related macular degeneration.
Further information: Novartis