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Minimal further treatment for DME needed at year 5 in Protocol I study

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SAN DIEGO — Visual acuity gains achieved during the first year of treatment with ranibizumab and prompt or deferred laser in patients with diabetic macular edema are maintained through 5 years, with minimal further treatment needed after 3 years, according to a speaker here.

John A. Wells III, MD, described the 5-year extended follow-up of the Diabetic Retinopathy Clinical Research Network (DRCR) Protocol I for treatment of DME at the American Society of Retina Specialists annual meeting.

John A. Wells III

“Previously, DRCR had reported that intravitreal ranibizumab with prompt or deferred laser was more effective in the treatment of DME through at least 2 years,” Wells said. “Interestingly, though, in 3-year comparison of the ranibizumab groups, prompt laser was no better and was possibly worse than deferred laser.”

Consequently, the study was extended to 5 years to assess a longer-term course of DME treated with Lucentis (ranibizumab, Genentech).

Approximately three-fourths of the patients in the original study were retained through 5 years. Starting in the second year, the interval between visits could be extended up to 16 weeks.

“In years 2 through 5 in both arms, the number of visits each year declined, indicating that there were a lot of stable eyes in the last 3 or 4 years of the trial,” Wells said.

Of a maximum of 65 visits, the prompt laser group had a mean of 38 visits and the deferred laser group had 40.

“Overall, over the course of the 5 years of the study, a median of 13 injections was given in the prompt laser group and 17 in the deferred laser group,” Wells said. “However, in the prompt group, about 40% of eyes received at least one injection in years 4 and 5, and in the deferred group, about half of those eyes received at least one injection in years 4 and 5, which indicates that there’s a need for long-term monitoring in these eyes for recurrent DME.”

Disclosure: Wells has been an investigator for Genentech.