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Ranibizumab Treatment in Patients with Diabetic Macular Edema

Sep 19, 2013

Anti-VEGF therapy with Ranibizumab is shown to be effective among DME patients with lower central retinal thickness…. 

Diabetic Macular Edema (DME) is a complication associated with diabetes that results in vision loss due to the accumulation of fluid in the central region of the eye. The accumulation of fluid impairs the cells in the eyes from sensing light, leading to blurred vision.

Treatment for DME usually consists of a surgical procedure involving laser treatment, the use of anti-VEGF therapy, or corticosteroid therapy. In a new phase 3, randomized and double-blind study, researchers compare the outcomes with ranibizumab drug treatment (anti-VEGF therapy) vs. laser treatment for diabetic macular edema.

Eligible participants were 18 years or older with type 1 or 2 diabetes and also had to be experiencing vision loss due to DME. The study was designed so that patients were randomized to receive ranibizumab 0.5 mg plus sham laser, ranibizumab 0.5 mg plus laser, or sham injections plus laser. Injections were administered for 3 consecutive months and then given as needed. Laser treatment, including sham laser, was given at baseline and then also as needed. Outcomes measures of the study were based on scores from the National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) at 0, 3, and 12 months.

After treatment, mean baseline NEI VFQ-25 scores were 72.8 for the ranibizumab group, 73.5 for the laser group, and 74.1 for the ranibizumab plus laser group. After a year, mean scores increased by 5.0 and 5.4 from baseline in the ranibizumab and ranibizumab plus laser groups, respectively. However, the laser group only increased by 0.6. Near and distance activities scores also showed significantly higher increases from baseline in the groups including ranibizumab treatment, rather than in the laser only group.

Furthermore, researchers observed that "patients with better baseline visual acuity or lower central retinal thickness had greater improvements with ranibizumab treatment compared with laser in composite and some subscale scores compared with patients with worse visual acuity or higher central retinal thickness."

In conclusion, this study provides the data to support the benefits associated with ranibizumab treatment for DME in certain individuals.

Mitchell P, et al. Patient-Reported Visual Function Outcomes Improve After Ranibizumab Treatment in Patients With Vision Impairment Due to Diabetic Macular Edema. JAMA Ophthalmol. 2013. doi:10.1001/jamaophthalmol.2013.4592