Ranibizumab injections in combination with laser therapy offers new treatment for DME

April 28, 2010

The Diabetic Retinopathy Clinical Research Network (DRCR.net) study, published in Ophthalmology online has shown that ranibizumab (Lucentis) injections, in combination with laser treatment has produced better vision results than in patients treated by laser alone for diabetic macular oedema (DME).

The Diabetic Retinopathy Clinical Research Network (DRCR.net) study, published online in Ophthalmology has shown that ranibizumab (Lucentis) injections, in combination with laser treatment has produced better vision results than in patients treated by laser alone for diabetic macular oedema (DME).

Supported by the National Eye Institute and the National Institute of Diabetes and Digestive and Kidney Diseases, the research comprised 52 clinical sites where nearly 50 percent of patients who received the new treatment experienced substantial visual improvement after 12 months, compared with 28 percent who underwent standard laser treatment.

Dr Neil Bressler, chair of the DRCR.net and chief of the Retina Division at the Wilmer Eye Institute, Johns Hopkins University said: “These results indicate a treatment breakthrough for saving the vision of people with diabetic macular oedema. Eye injections of ranibizumab with prompt or deferred laser treatment should now be considered for patients with characteristics similar to those in this clinical trial.”

“This comparative-effectiveness study demonstrated that a new treatment can protect and, in many cases, improve the vision of people with diabetic macular oedema,” said NEI Director Dr Paul A. Sieving, PhD.

The current study included a total of 854 eyes of 691 people, who had one or both eyes treated. Participants, who were on average in their early 60s, were diagnosed with type 1 or 2 diabetes and macular oedema. They were randomly assigned to one of four study groups: sham injections plus prompt laser treatment within one week; ranibizumab injections plus prompt laser treatment; ranibizumab plus deferred laser treatment after six months or more; or injections of corticosteroid medication known as triamcinolone (Trivaris) plus prompt laser treatment.

Ranibizumab injections could be given as often as every four weeks, and triamcinolone injections or laser treatments could be given as often as every 16 weeks. In general, treatment was continued until a participant's vision or retinal thickness returned to normal, or additional treatment did not improve vision or retinal swelling.

After one year, nearly 50% of eyes treated with ranibizumab and prompt or deferred laser treatment showed a substantial visual improvement. People could read at least two additional lines on an eye chart with the treated eye, or letters that were at least one-third smaller than they could read before the study treatment. Fewer than 5% of eyes in these groups experienced a visual loss of two or more lines. The results were similar whether patients received prompt or deferred laser treatment with the ranibizumab injections.

In contrast, about 30% of eyes that received laser treatment alone or triamcinolone plus laser showed a visual improvement of two or more lines on an eye chart, while 13 to 14% of eyes in these groups had a visual loss of two or more lines.

Although participants in all three injection groups had a greater decrease in retinal thickness after one year than with laser treatment alone, patients who received triamcinolone injections had greater complication rates.

About 30% of people in the triamcinolone group developed high eye pressure that required medications, and about 60% developed cataracts that required surgery.

Few participants who received eye injections of ranibizumab had eye-related complications, such as an infection inside the eye likely caused by the injections, or worsening of a retinal detachment that existed prior to beginning treatment. The study found that eye injections of ranibizumab were not associated with any serious risks such as heart attack or stroke. DRCR.net researchers will continue to monitor the study participants for at least three years to obtain additional information about the safety and effectiveness of these macular edema treatments.