Abstract
Background: To evaluate intravitreal 0.5 mg ranibizumab plus laser with 0.3 mg pegaptanib plus laser with focal/ grid laser alone for treatment of diabetic macular edema (DME) Methods: A total of 45 study eyes with DME involving the fovea and visual acuity (VA) of 20/32 or worse were randomized into three groups, ranibizumab 0.5 mg + prompt laser (Group 1), pegaptanib sodium 0.3 mg + prompt laser (Group 2) and laser alone (Group 3) with 15 eyes in each study arm. Retreatment was based on optical coherence tomography measurements and VA changes. Results: The mean VA change (± standard deviation) at 1 year in Groups 1, 2 and 3 were 10.4±2.1, 7.6±2.3 and 2±2.7 letters (p<0.001) respectively on a standardized ETDRS chart. There was no significant difference between the VA gain between Group 1 and 2 at 1 year (p=0.189) however significant difference existed between Groups 1 and 2 when compared to Group 3 (p=0.0001). Conclusions: Ranibizumab and Pegaptanib with prompt focal/grid laser proved to be more effective than prompt focal/grid laser alone in treatment of center involved DME. There was no statistical difference in the visual gain achieved in the two intravitreal groups.
Highlights
Diabetic mellitus (DM) is a common metabolic disorder characterized by sustained hyperglycemia of variable severity, secondary to lack, diminished efficacy, or both of endogenous insulin
Focal/grid photocoagulation, the current standard care for diabetic macular edema (DME), has been the mainstay of treatment since its benefit was demonstrated in the Early Treatment Diabetic Retinopathy Study (ETDRS) in 1985 [1]
Recent trials involving anti vascular endothelial growth factor (VEGF) alone or in combination with laser have demonstrated the possibility of better visual gain in DME patients as compared to laser alone [5,6,7]
Summary
Diabetic mellitus (DM) is a common metabolic disorder characterized by sustained hyperglycemia of variable severity, secondary to lack, diminished efficacy, or both of endogenous insulin. Focal/grid photocoagulation, the current standard care for diabetic macular edema (DME), has been the mainstay of treatment since its benefit was demonstrated in the Early Treatment Diabetic Retinopathy Study (ETDRS) in 1985 [1]. Other treatment modalities, including anti-vascular endothelial growth factor (VEGF) therapy and steroids, alone or in combination with laser, are under investigation [3, 4]. Recent trials involving anti vascular endothelial growth factor (VEGF) alone or in combination with laser have demonstrated the possibility of better visual gain in DME patients as compared to laser alone [5,6,7]. There was no study comparing a pan anti- VEGF like bevacizumab and ranibizumab with a selective anti-VEGF like pegaptanib sodium in patients of center involved DME. To evaluate intravitreal 0.5 mg ranibizumab plus laser with 0.3 mg pegaptanib plus laser with focal/ grid laser alone for treatment of diabetic macular edema (DME)
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