Here is excellent news for individuals who have diabetes and associated diabetic macular edema: On August 10, 2012, the United States Food and Drug Administration (FDA) approved Genetech’s Lucentis (generic name ranibizumab) for the treatment of diabetic macular edema (DME). In its approval announcement, the FDA noted that Lucentis is for use in persons with “good diabetic sugar control” and is designed to be given once a month as an injection into the eye by a qualified health care professional.
About Diabetic Macular Edema
Diabetic macular edema [edema = a swelling or accumulation of fluid] (DME) can occur in people with diabetes when retinal blood vessels begin to leak into the macula, the part of the eye responsible for detailed central vision. These leakages cause the macula to thicken and swell, which, in turn, creates a progressive distortion of central vision.
Although this swelling does not always lead to severe vision loss or blindness, it can cause a significant loss of central, or detail, vision, and is the primary cause of vision loss in people with diabetic retinopathy. You can read more about diabetes and diabetic retinopathy at the VisionAware website.
More about Lucentis
Lucentis is an anti-angiogenic drug (more about that below) that was developed for injection in the eye to block blood vessel growth in age-related macular degeneration (AMD). In 2005, clinical trials established Lucentis as highly effective for the treatment of wet AMD and the FDA approved the use of Lucentis in 2006. In 2010, after a series of clinical trials, the FDA approved Lucentis for the treatment of macular edema following retinal vein occlusion.
Angiogenesis is a term used to describe the growth of new blood vessels and plays a crucial role in the normal development of body organs and tissue. Sometimes, however, excessive and abnormal blood vessel development can occur in diseases such as cancer (tumor growth) and AMD (retinal and macular bleeding).
Substances that stop the growth of these excessive blood vessels are called anti-angiogenic(anti=against; angio=vessel; genic=development), and anti-neovascular (anti=against; neo=new; vascular=blood vessels). The focus of current anti-angiogenic drug treatments for eye disease is to reduce the level of a particular protein (vascular endothelial growth factor, or VEGF) that stimulates abnormal blood vessel growth in the retina and macula; thus, these drugs are classified as anti-VEGF treatments. At present, these drugs are administered by injection directly into the eye after the surface has been numbed.
You can read more about Lucentis in Avastin and Lucentis for Macular Degeneration: Head-to-Head Once Again and Avastin and Lucentis: Cardiovascular Risks? A New Canadian Study Says No.
Research Supporting the FDA Approval
The safety and effectiveness of Lucentis in treating DME were established via two clinical trials involving 759 patients who were treated and followed for three years. The results of these two trials, called the RISE Study and the RIDE Study, were reported in the April 2012 issue of Ophthalmology, in Ranibizumab [i.e., Lucentis] for diabetic macular edema: results from 2 phase III randomized trials: RISE and RIDE.
Ophthalmology is the official journal of the American Academy of Ophthalmology and publishes original, peer-reviewed research that addresses diagnostic and surgical techniques, treatment methods, the latest drug developments, results of clinical trials, and research findings.
The authors are Quan Dong Nguyen, MD; David M. Brown, MD; Dennis M. Marcus, MD; David S. Boyer, MD; Sunil Patel, MD, PhD; Leonard Feiner, MD, PhD; Andrea Gibson; Judy Sy, PhD; Amy Chen Rundle, MS; J. Jill Hopkins, MD; Roman G. Rubio, MD; Jason S. Ehrlich, MD, PhD; and the RISE and RIDE Research Group.
About the Study: the Basics
The purpose of the RISE and RIDE studies was to evaluate the safety and effectiveness of Lucentis eye injections in individuals with DME. The study subjects were randomly assigned to receive monthly injections of Lucentis at (a) 0.3 milligrams (mg); (b) 0.5 mg; or (c) no injections during the first 24 months of the studies. After 24 months, all subjects received monthly Lucentis injections, either at 0.3 mg or 0.5 mg. Both studies measured the number of subjects who gained vision, as measured by an eye chart.
The Study Conclusions
According to the FDA, the study results revealed that 34 to 45 percent of the subjects who were treated with monthly Lucentis 0.3 mg injections gained at least three lines of vision (as measured on an eye chart) compared with 12 to 18 percent of those who did not receive an injection. No additional benefit was observed with the higher monthly Lucentis dose of 0.5 mg. Side effects from the drug included eye pain, bleeding, floaters, and increased intraocular [i.e., within the eye] pressure.
Additional results, as reported in the journal Ophthalmology, included the following:
[Lucentis] rapidly and sustainably improved vision, reduced the risk of further vision loss, and improved macular edema in patients with DME, with low rates of ocular and nonocular harm … Whether, and for how long, the beneficial effects of [Lucentis] on retinopathy severity and progression persist after therapy cessation, however, also needs to be determined … The current studies were not designed to address this question. Additional follow-up of patients in these studies will provide further long-term guidance on systemic safety [i.e., risks and benefits].
For physicians managing diabetes and from a public health perspective, these data should be discussed with patients to underscore the importance of appropriate eye care to address the challenge of vision loss. Compliance with established screening guidelines is poor; only 40% to 50% of US adults with diabetes receive recommended eye examinations.
Ophthalmologists now have a substantial body of evidence supporting [Lucentis] treatment as a new approach to DME management, focusing not only on vision preservation, but also on vision improvement. Treatment with [Lucentis] also has beneficial effects on retinopathy progression and risk of further vision loss, and tolerable risks of harm. The present studies of [Lucentis] provide the longest-term evidence to date that visual loss from DME can be reversed and that clinically significant, sustained visual improvements can be achieved.