Lucentis in DME: so far so good

November 14, 2006

Ranibizumab (Lucentis; Novartis) is an effective treatment for diabetic macular oedema (DME), according to Peter Campochiaro, MD, from the Department of Ophthalmology, Wilmer Eye Institute, USA, speaking at the Retina Subspecialty Day.

Ranibizumab (Lucentis; Novartis) is an effective treatment for diabetic macular oedema (DME), according to Peter Campochiaro, MD, from the Department of Ophthalmology, Wilmer Eye Institute, USA, speaking at the Retina Subspecialty Day.

Twenty patients with chronic macular oedema were enrolled in a Phase I trial. Inclusion criteria included a foveal thickness of 250 microns or greater, vision of 20/40 to 20/320, no laser treatment during the previous three months, no periocular or intraocular steroids for four months or anti-angiogenic treatment for 12 months. The study design called for an intravitreal injection of 0.5 mg of ranibizumab at baseline and at one, two, four and six months. The primary end-point was month seven and the patients were followed for one year.

Dr Campochiaro used the the optical coherence tomography scans of two patients to demonstrate the results. "The response to ranibizumab was rapid," he reported. "One week after the first injection, there was marked improvement in the foveal thickening. In one patient the improvement remained for the duration of the trial; in the second patient, there was an initial improvement one week after injection, but the improvement deteriorated over one and two months with the development of substantial macular oedema."

All twenty patients responded to ranibizumab, but the pattern of the response differed among patients. The improvement in the mean excess foveal thickness at the primary end point was about 87%, an improvement that Dr Campochiaro described as "dramatic."

Even one year after treatment, there was still substantial improvement in the foveal thickness. At the primary end point, the median improvement in foveal thickness was 300 microns, a 97% improvement. The mean improvement in visual acuity was 10 letters.

"Six months after the last treatment, there was still significant improvement compared with baseline, raising the following questions: What is the appropriate interval for the injections? What are the long-term effects of the treatment? Is there any benefit to combining this treatment with laser treatment?" Dr Campochiaro posed.

A Phase II trial is planned.