DRCRJ
Patients with diabetic retinopathy are at risk for decreased vision after laser treatment. This happens when the retina swells after intense laser treatment. This study will determine whether an injection of either Lucentis™ or a steroid medication will reduce that risk by treating the retinal swelling.
Participants are separated into three groups. The first group will receive two Lucentis™ injections. The second group will receive one injection of a steroid medication and one “sham” (placebo) injection. The third group will receive two “sham” (placebo) injections. The study will last 56 weeks.
The following is a brief summary of inclusion/exclusion criteria in technical terminology. You may wish to share this information with your doctor to determine if you are eligible for the study. Please note that this is not a complete list.
Inclusion:- Age 18 or older
- Type 1 or type 2 diabetes
- Study eye with severe NPDR or PDR which needs PRP laser treatment
- DME with thickening of greater than or equal to 250 on OCT
- Visual acuity of 20/320 or better
Exclusion:- Significant renal disease, requiring dialysis or transplant
- Unstable medical condition, i.e. blood pressure, cardiovascular disease, or glycemic control
- Heart attack, stroke, CHF or TIA within 4 months prior to randomization
- Pregnancy
- History of treatment of DME within the past 4 months (laser, steroid injection, or any other treatment) prior to enrollment
- History of major ocular surgery within 4 months prior of enrollment
- History of YAG within 2 months of enrollment
- IOP of greater than or equal to 25, or history of open-angle glaucoma
