Abstract
Purpose: :
To study the contrast sensitivity as measured by the Pelli-Robson charts in eyes with diabetic macular edema treated with metabolic control and bevacizumab intravitreous injection
Methods: :
Prospective, randomized, interventional case series. Eleven eyes of 8 patients with type 2 DM, glycated haemoglobin(G-Hb) less than 11% and macular edema with no previous treatment, were randomized (1:1) in two groups. The baseline examination consisted of visual acuity (VA), contrast sensitivity using the Pelli-Robson Charts (CS), Stratus OCT macular map and angiofluoresceinography for all eyes. In group 1, two patients were lost to follow-up. Both groups were scheduled for rigid metabolic control. Group 1 (4eyes) was treated with intravitreous (IV) bevacizumab (1.25mg) in the week 0,6,12 and 18. Group 2 (seven eyes) received a sham injection at weeks 0 and 6; and IV-bevacizumab in the weeks 12 and 18. This pilot study shows data up to week 12 (before the third injection) comparing only two sham with two bevacizumab injections. Data was analysed by the Mann-Whitney test.
Results: :
The mean VA, OCT measurement at fovea and CS for groups 1 and 2 were at baseline respectively: 0.715logMAR+/-0.264 and 0.700logMAR+/-0.160 (p=0.63); 506.75µ+/-87.67 and 579.85µ+/-235 (p=0.85); 1.087logCS+/-0.18 and 1.05logCS+/-0.35 (p=1.0). The mean VA, OCT and CS for groups 1 and 2 were at week 12 respectively 0.645logMAR +/-0.281 and 0.637logMAR+/-0.189 (p=0.92); 458.25µ+/-78.47 and 513.28µ+/-132 (p=0.85); 1.162logCS+/-0.332 and 0.942log CS +/-0.296.(p=0.69). The mean G-Hb at baseline and 12 weeks were 8.33% (8.2 to 9.1) and 8.1% (6.9 to 8.7) in group 1 and; 8.93% (7.7 to 10.3) and 7.79% (7.0 to 8.1) at baseline and 12 weeks respectively for group 2. No statistically significant difference was found between the two groups for VA, OCT or CS at week 12.
Conclusions: :
Concerning the VA, CS and macular thickness, two consecutives intravitreous injections of bevacizumab and rigid metabolic control was comparable to sham injection associated with rigid metabolic control, for macular edema over 400µ at baseline.
Clinical Trial: :
www.hcnet.usp.br/adm/dc/cappesc #0875/08
Keywords: diabetic retinopathy • macula/fovea • drug toxicity/drug effects