Image: PD Diabetic Macular Edema
1. Mean patient-reported visual improvement scores increased with ranibizumab monotherapy and ranibizumab + laser with an increase of 5.0 and 5.4 points respectively compared to the 0.6-point increase in the laser-only treatment (p<0.05).
2. 49.1% of patients undergoing ranibizumab therapy achieved a 5-point improvement, compared to 42.2% of the ranibizumab monotherapy group and 30.6% of the laser-only group.
Evidence Rating Level: 1 (Excellent)
Study Rundown: This study is important in demonstrating that ranibizumab treatment has a positive effect on vision in patients with diabetic macular edema. Given today’s focus on outcome-based guidelines, this study is essential in demonstrating that diabetic patients experience an improvement in their vision after treatment with ranibizumab. The study provides crucial corroboration to the RESTORE trial, a previous study that demonstrated a significant improvement in measured visual acuity after ranibizumab treatment. Even without laser treatment, ranibizumab has a tremendous impact on vision. Strengths of this study include the fact that the study had a large database of patients throughout the world and that a standardized scoring system was utilized. Limitations include that the study was only carried out to 12 months, while the RESTORE trial lasted for 3 years. Thus, it is difficult to ascertain whether the increase in patient-perceived visual acuity remains after the first year.
In-Depth [randomized study]: This study attempted to obtain patient-reported visual outcome improvements with the use of ranibizumab for diabetic macular edema, a cause of visual impairment among diabetic patients. The study utilized National Eye Institute Visual Functioning Questionnaire 25 (NEI VFQ-25) to receive an objective report of visual functioning per the patient. An improvement of 4-6 points reflects a clinically relevant increase in visual acuity of at least 15 letters. Diabetic patients with reduced vision due to macular edema were randomly assigned to one of three groups – ranibizumab + sham laser, ranibizumab + laser, or sham injection + laser. Injections were administered monthly, while laser was utilized as needed. Mean composite scores increased with ranibizumab monotherapy and ranibizumab + laser with an increase of 5.0 and 5.4 points respectively (p<0.05). These effects lasted from the 3-month time point to the 12-month time point. 49.1% of patients undergoing ranibizumab therapy achieved a 5-point improvement, compared to 42.2% of the ranibizumab monotherapy group and 30.6% of the laser only group. There was no difference if the eye that was treated was the better or worse eye. Regression analysis demonstrated that treatment with ranibizumab was a strong predictor of higher scores.
By Swarup Swaminathan and Andrew Bishara
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