RIDELucentis® is an injectable drug that has been proven successful in treating macular degeneration. This clinical trial will last 36 months and is designed to evaluate the effect of Lucentis® on macular edema (retinal swelling) due to diabetic retinopathy.
Study participants will be placed in two groups. The first group will receive monthly injections of Lucentis®. The second group will receive monthly “sham” (placebo) injections. Eligible candidates must be age 18 or older; have type 1 or type 2 diabetes; and have swelling in the retina.
The following is a brief summary of inclusion/exclusion criteria in technical language. You may wish to share this information with your doctor to determine if you are a candidate. It is important to note this is not a complete list.
Inclusion:
- Diabetic macular edema with a central thickness of greater than or equal to 275 on OCT.
- Visual acuity in the study eye of 20/40- 20/320
- Use of appropriate birth control (if applicable)
Exclusion:
- History of PRP or macular laser within 3 months of screening, or history of vitreoretinal surgery (study eye)
- Previous treatment in study eye with intraocular corticosteroids or anti-angiogenic drugs in either eye
- Cataract surgery within 3 months, YAG laser within 2 months, or any intraocular surgery within 90 days of day 0 (study eye)
- Uncontrolled glaucoma (IOP greater than or equal to 30 despite medication)
- Spherical equivalent of -8.00 in study eye
- Uncontrolled blood pressure (greater than 180/110)
- History of CVA (stroke) or heart attack within 3 months prior to day 0
- HbA1c of greater than 12
- Renal failure requiring dialysis or transplant
- Pregnancy
