Is ranibizumab significantly more effective than standard of care for vision loss due to DMO?

May 28, 2010

According to Novartis the independent DRCR.net study data being presented for the first time in the UK, show that ranibizumab is significantly more effective than laser treatment, the current standard of care, at treating visual impairment due to diabetic macular oedema (DMO).

According to Novartis the independent DRCR.net study data being presented for the first time in the UK, show that ranibizumab is significantly more effective than laser treatment, the current standard of care, at treating visual impairment due to diabetic macular oedema (DMO).

In a press statement the company said results from an independent study (854 eyes) showed that at one year, the mean improvement in best corrected visual acuity (BCVA) from baseline was significantly greater in both of the ranibizumab plus laser groups compared with the sham plus laser group. Reduction in mean central foveal thickness was greater in both of the ranibizumab plus laser groups than the sham plus laser group.

After one year, nearly 50 percent of eyes treated with ranibizumab and prompt or deferred laser treatment showed a substantial visual improvement. These 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 percent of eyes in these groups experienced a visual loss of two or more lines. The results were similar regardless of whether patients received prompt or deferred laser treatment with the ranibizumab injections.

First results of the RESTORE Phase III study (354 eyes), were also presented at the Royal College of Ophthalmologists Annual Congress in Liverpool, showing that ranibizumab is significantly more effective at treating visual impairment due to DMO, compared to the current standard of care, laser treatment.

At one year, the RESTORE results show that 37% of patients treated with ranibizumab 0.5 mg alone, and 43% of those treated with ranibizumab plus laser therapy, gained a substantial vision improvement of 10 letters or more on an eye-chart, versus 16% of patients treated with laser alone.

“These data offer hope to patients affected by this disabling disease. Laser has been used to treat DMO for over 25 years and can reduce the risk of significant vision loss, but is not generally associated with visual improvement. The data from the latest DMO trials show that ranibizumab produces a rapid and sustained improvement in vision and are extremely significant for the medical community and patients alike” said Riaz Asaria, Consultant Ophthalmologist at the Royal Free Hospital, London.

The safety profile of ranibizumab in RESTORE and the DRCR.net studies is consistent with that previously observed in large controlled clinical trials, with no new safety risks observed. Ranibizumab intravitreal injections were well tolerated and there was a low incidence of arterial thromboembolic events in all treatment groups.

These efficacy and safety data support the earlier results of the pivotal RESOLVE study comparing ranibizumab to sham treatment, where patients gained vision improvement of 11.9 letters when treated with ranibizumab, forming the basis of the EU licence submission.

The safety profile of ranibizumab in DMO is comparable to that seen in previous studies for Age-related Macular Degeneration (AMD), adding further weight to its established safety profile, shown through the robust Lucentis clinical trial programme.

“The results of the RESTORE study demonstrate that ranibizumab offers a much needed solution to improve vision-related quality of life for thousands of diabetic patients, without compromising safety. Data from the RESTORE trial also supports earlier evidence that ranibizumab has the potential to transform the standards of care for diabetic macular oedema in the UK, by rapidly improving vision,” said Mr. Nicholas Beare, Consultant Ophthalmologist, Royal Liverpool University Hospital, lead investigator in the RESTORE trial.