Lucentis May Treat Diabetes-Related Vision Loss
Studies Show Drug May Help Treat Patients With Diabetic Macular Edema
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Treatment With Lucentis continued...
Nearly two-thirds of those on the higher Lucentis dose recovered enough eyesight to be able to legally drive, compared with 38% of those getting a placebo.
In the other, 382-patient study, called RIDE, 34% on a low dose of Lucentis and 46% of those on a higher dose were able to read an additional 15 or more letters on the eye chart, compared with 12% of patients getting placebo.
About 54% on the low Lucentis dose and 62% on the high dose recovered enough vision to be able to drive, compared with 35% receiving a sham treatment.
Nearly three in four patients on placebo required rescue laser treatments to stabilize vision vs. only 29% to 39% of Lucentis-treated patients.
Patients in both studies were given either sham or Lucentis shots for 24 months.
The Lucentis injections were generally safe, with overall side effects similar to those of sham injections, Boyer says.
However, cardiovascular problems, which included heart attacks, strokes, and deaths due to vascular conditions, affected 6% to 9% of patients given the higher dose of Lucentis compared with about 5% on sham.
High blood pressure was also more common with high-dose Lucentis: 2% to 3% vs. 0% to 1% with sham.
The studies were funded by Genentech. The company plans to submit the studies to the FDA later this year to seek approval for use of Lucentis in DME.
These findings were presented at a medical conference. They should be considered preliminary as they have not yet undergone the "peer review" process, in which outside experts scrutinize the data prior to publication in a medical journal.