Objective: To study real world outcomes of ranibizumab (Lucentis) intravitreal injection in diabetic macular oedema (DMO).
Subjects and methods: We included 100 patients with DMO. Those who had optical coherence tomography central retinal thickness (CRT) of 400μm or more (Group 1) underwent combination treatment with ranibizumab and macular LASER, while those with CRT less than 400μm (Group 2) had LASER monotherapy. The primary outcome measure was change in best corrected visual acuity (BCVA) from baseline. Secondary outcomes were change of CRT from baseline, the number of intravitreal injections in group one during the first and second year of follow-up and the proportion of LASER sessions in both groups at 2 years follow-up. Patients' lipid profile was compared to the presence and extent of macular hard exudates, quantified using masked readers and image analysis software.
Results: Group 1 showed better outcomes in terms of BCVA and CRT compared to Group 2 during the two-year follow-up period. The mean number of ranibizumab intravitreal injections in Group 1 was reduced from 3.86 (standard deviation±1.37) in the first year to 2.02 in the second year. At 2 years, Group 1 had a higher proportion of individuals that had undergone 3 macular LASER treatments (4% Group 1, 28% Group 2). The presence of hard exudates was associated with higher total cholesterol (P=0.004 and P=0.041 group 1 and 2 respectively) and with higher low density lipoprotein (LDL) cholesterol (P=0.01 and P=0.045 respectively). The size of hard exudates was associated with higher total cholesterol (P=0.02 and P=0.03 respectively) and with higher LDL cholesterol (P=0.003 and P=0.01 respectively). Neither high density lipoprotein (HDL) cholesterol, nor triglycerides were related to the presence or size of hard exudates. No serious adverse events were attributed to either LASER or ranibizumab.
Conclusions: Combination treatment of intravitreal ranibizumab injections and macular LASER appears safe and effective over two years. The need for injection declines over time. There is an association between higher levels of serum total and LDL cholesterol and the presence and the extent of hard exudates.