Anti-VEGF improves vision in diabetic macular edema patients, phase 3 study shows

BERLIN — A phase 3 study of pegaptanib sodium injection treatment for patients with diabetic macular edema showed significantly improved visual results, according to a researcher here.

"Macugen for the treatment of DME was evaluated in a multicenter, randomized, sham-controlled, double-masked trial," Marla B. Sultan, MD, MBA, said in an interview with Ocular Surgery News at the World Ophthalmology Congress. "Our primary endpoint was proportion of patients achieving greater than or equal to 10 letters improvement in vision over 57 weeks, and 37% of patients in the pegaptanib group as opposed to 20% in sham achieved that."

The study results were presented at the meeting by Frank G. Holz, MD. The standard of care in the sham treatment group was laser, which could be administered after week 18 and as often as every 17 weeks, Dr. Sultan said.

The study also showed a mean visual acuity gain at 54 weeks of 5.2 letters in the Macugen (pegaptanib, Eyetech/Pfizer) group vs. 1.2 letters in the sham group, and at 102 weeks, a gain of 6.1 letters in the pegaptanib group vs. 1.3 in the sham group, Dr. Sultan said. These findings were also statistically significant.

"The incidence of diabetes is rising and the expectation is that the patient population will increase up to 2020, so patients with diabetic macular edema are often of working age, so it's very important to find an option for patients other than laser," she said. "Unfortunately, diabetes is a lifetime disease."

Safety results were collected throughout the study, and pegaptanib was well-tolerated. There was an increase in IOP related to injection procedure that was 2.5 times greater in the pegaptanib arm (n = 17) than in the sham arm (n = 7).

"All findings in the study were consistent with what has been found previously in clinical trials of pegaptanib in the AMD population," Dr. Sultan said.

The study was conducted on 260 patients with DME at 56 global sites beginning in September 2005.

"We are really excited," Dr. Sultan said. "It's really good to see those results and have another potential treatment option for patients."

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