How safe and effective is biological therapy ranibizumab for patients with diabetic macular edema?

This study examined the effectiveness and safety of biological therapy ranibizumab (Lucentis) for patients with diabetic macular edema (DME) that has never been treated. After one year, patients’ vision had improved significantly, particularly for patients who received 5 injections instead of 4.

Diabetic macular edema (DME) is a complication caused by diabetes. It occurs when high glucose levels cause blood leakage into the retina at the back of the eye. The retina is the part of the eye that senses images, so patients with DME have reduced vision. 

Ranibizumab is a biological therapy that prevents blood leakage into the eye. Ranibizumab has shown good success for patients with DME in clinical trials. It is unclear if it is as successful for patients who are not participants in a trial that have not previously received treatment for DME.

1063 patients with DME who have not been treated before were included. They were given ranibizumab injections into the eye by their doctor. These patients had not previously received treatment for DME. Patients’ vision was assessed 1 year after beginning treatment.

After 1 year, patients’ vision had improved by 3.5 vision points. Of these patients, those that received 4 or fewer injections had an improvement of 0.5 vision points. Those that received 5 or more injections improved by 6.9 vision points. The number of patients that could read 73 or more letters in the vision test increased from 19.7% to 69% after 1 year.

7.2% of patients developed eye-related side effects. The most common side effects were cataracts (1.6%), bleeding (0.8%), and fluid in the eye (0.7%). 10.1% of patients developed other types of side effects. The most common of these were the flu (0.8%), headaches (0.7%), and pneumonia (0.6%).

The authors concluded that ranibizumab was effective and safe for patients with DME that had not previously received treatment.

The manufacturer of ranibizumab, Novartis, funded this study. There was no placebo or comparison treatment in this study, making it difficult to fully understand its effectiveness.