Diabetic retinopathy, a complication of diabetes, has been treated by laser treatment (photocoagulation) as well as surgical removal of the vitreous gel (vitrectomy). In February, the Food and Drug Administration (FDA) approved the drug Lucentis, (ranibizumab), an intravitreal injection, to be used in the treatment of diabetes retinopathy for patients with diabetic macular edema (DME). Lucentis is also indicated for the treatment of patients with wet age-related macular degeneration, and macular edema following retinal vein occlusion. Lucentis, which is proposed to inhibit a vascular endothelial growth factor (VEGF) is recommended to be injected once monthly.
During the clinical trials, Lucentis’s effectiveness was evaluated in treating diabetic macular edema and diabetic retinopathy.
Clinical trials involving Lucentis vs. comparator group reported the following results:
- Significant improvement in the severity diabetic retinopathy Lucentis > comparator group
- Prevention of loss of visual acuity and maintaining visual acuity Lucentis >comparator group
- Decrease in leakage from choroidal neovascularization Lucentis>comparator group
Side effects reported for Lucentis included:
- Infections inside the eye
- Detached retinas, and cataracts
- Inflammation inside the eye
- Increased intraocular pressure
- Eye pain
- Small specks in vision, vitreous floaters
A caution that both providers and patients need to know is that endophthalmitis, which is an inflammation of the internal coats of the eye, or retinal detachment may occur following intravitreal injections. In addition, There is a potential risk of arterial thromboembolic events following intravitreal use of a VEGF inhibitor.
Prior to, and 30 minutes following, the intravitreal injection, patients should be monitored for elevation in intraocular pressure using tonometry. Monitoring may also consist of a check for perfusion of the optic nerve immediately after the injection. Patients should also be monitored for and instructed to report any symptoms suggestive of endophthalmitis following the injection.
Up to now, the main treatment for diabetic retinopathy involved using lasers to essentially burn away tissue at the edges of the retina. The procedure works, but it essentially destroys a person’s peripheral vision. Lucentis presents another option for patients with diabetic retinopathy, but as discussed there are many risks associated with this new injection.
Both patients and providers have to weigh risk versus benefit before the patient can undergo the treatment. Another important issue is the issue that involves the cost of the medication otherwise known as medication coverage. Although studies have shown benefit in treating patients with diabetic retinopathy the cost of the injection may turn out to be more expansive than currently used photocoagulation when it comes to materials and staff. As is shown with other new medications that come on the market, new medications ends up in a non-preferred brand name category for the treatment and may cost the patient more in the form of copayment.
Photocoagulation may be classified as a surgical procedure and may have different insurance coverage that may vary based on whether or not the provider is in-network or out-of-network for the specific insurance company. I believe that after evaluating the benefits together with the risks and the costs, Lucentis can be an option for many patients for whom photocoagulation or any other surgical treatment is not an option.