07 March 2012
Lucentis® (ranibizumab) Available for Treatment of Diabetic Macular Edema;

DME Leading Cause of Blindness in Most Developed Countries among Working-Age Population

Dubai, United Arab Emirates: Diabetic patients are set to benefit from a new treatment for diabetic macular edema (DME), a leading cause of blindness among the working-age population in most developed countries.

A new indication for Lucentis® (ranibizumab) has become available to treat patients with DME, a complication of diabetes that causes fluid to accumulate in the central portion of the eye resulting in blurred vision that, if left untreated, can lead to loss of sight.

Laser therapy is the current standard treatment for the debilitating illness, which generally only stabilises the condition without improving vision. The new indication is the first licensed therapy to significantly improve both vision and vision-related quality of life in patients with visual impairment due to DME - a consequence of diabetic retinopathy, the most common diabetic eye complication.

"The bulk of the people with retinal disease I see in my clinic have diabetic retinopathy, which is a direct result of uncontrolled diabetes, something that is a significant issue here in the UAE," said Dr. Nazimul Hussain, Retina Specialist at Al Zahra Hospital, UAE

DME affects up to 12 percent of those with diabetic retinopathy (1) - an eye disease that develops in about 40 percent of those with diabetes (2). Diabetes affects approximately 20 percent of the population in the UAE (3), and DME is directly linked to poor blood sugar control that underscores the disease.

"I have been very pleased with results of combining standard laser therapy with Lucentis to treat DME, especially because repeated laser therapy can damage the neurosensory elements of the eye," said Dr. Hussain.

Ophthalmologists can detect DME during routine eye screening, which all diabetes patients are recommended to have at least once a year and, with early diagnosis and treatment, any loss of vision resulting from DME can be improved.

An independent US study has shown ranibizumab improves visual acuity in 50 percent of DME patients when given in combination with standard laser treatment, compared with just 28 percent of patients given laser treatment alone (4).

The Novartis-sponsored trial RESTORE showed that patients treated with ranibizumab alone or in conjunction with laser therapy gained an average of 6.8 and 6.4 letters respectively in visual acuity at 12 months, while laser-treated patients gained an average of 0.9 letters as measured on a standard ETDRS eye chart.

Similarly, the Novartis-sponsored RESOLVE study showed that ranibizumab-treated patients gained an average of 10.3 letters in visual acuity at 12 months compared to baseline, while "dummy"-treated patients, some of whom also received laser-treatment, lost an average 1.4 letters.

Future cases of DME can be prevented with good diabetes care, said Dr. Hussain, where blood sugar levels are maintained within recommended targets, as well effective treatment of other associated diseases such as hypertension and hyperlipidemia.

"DME is easy to detect, and every single diabetic patient should be referred to an ophthalmologist for regular eye exams as recommended. It's a combined effort between endocrinologists and ophthalmologists to help prevent and treat diabetes-related eye complications," he added.

DME is characterized by changes in the blood vessels of the retina, which is the light-sensitive layer at the back of the eye. In patients with DME, leakage from these abnormal blood vessels occurs in the central portion of the retina, called the macula. Because this part of the eye is responsible for sharp central vision, DME can lead to significant visual impairment. Visual impairment due to DME affects approximately 1-3 percent of patients with diabetes.

Ranibizumab is currently used in treatment of wet age-related macular degeneration (AMD), a disease associated with aging that gradually destroys sharp, central vision.

References:

[1] Burden of Illness of Diabetic Macular Edema: Literature Review in Current Medical Research and Opinion. 2010 Jul;26(7):1587-97. 

[2] The Prevalence of Diabetic Retinopathy among Adults in the United States. Archives of Ophthalmology. 2004 April;122(4): 552-63.

[3] International Federation of Diabetes: UAE figures http://www.idf.org/diabetesatlas/5e/the-global-burden

[4] Randomized Trial Evaluating Ranibizumab Plus Prompt or Deferred Laser or Triamcinolone Plus Prompt Laser for Diabetic Macular Edema.

Ophthalmology. 2010 June; 117(6): 1064-1077.e35. www.ncbi.nlm.nih.gov/pmc/articles/PMC2937272/

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© Press Release 2012