A phase II, 12 month, randomized, sham-controlled trial of ranibizumab (Lucentis) combined with grid laser compared with laser alone for the treatment of recalcitrant, diabetic macular oedema.

Diabetic macular edema (DMO) is a complication of diabetes where fluid builds up in the center of the retina (the back of the eye), causing blurry vision. This study is testing whether combining the drug ranibizumab (Lucentis — an injection into the eye) with laser treatment works better than laser treatment alone for people whose DMO has not improved enough with laser treatment in the past. Researchers are also trying to design a treatment schedule that requires fewer clinic visits and injections than current approaches. You may be eligible if: - You are 18 years or older - You have diabetic macular edema that affects the center of your retina (fovea) - Your retinal thickness on an OCT scan is greater than 250 microns in the center, or greater than 300 microns around the center - Your best-corrected vision falls between 6/12 and 6/477 on a standard eye chart - You have already had at least one full course of laser treatment for your DMO, at least 4 months ago - Your kidney function is adequate You may NOT be eligible if: - You have poor blood flow in the macula (macular ischemia) - You have untreated new blood vessel growth in the retina or iris - You have scarring or atrophy under the central retina in the study eye - You have had vitrectomy surgery in the study eye - You are pregnant, breastfeeding, or not using reliable birth control (if of childbearing age) - You have had a stroke or heart attack in the past - You have a known allergy to ranibizumab - You have had an anti-VEGF injection within the past 6 weeks Talk to your doctor about whether this trial might be right for you.