Ranibizumab and Bevacizumab for Diabetic Macular Edema
Status:
Completed
Trial end date:
2015-02-01
Target enrollment:
Participant gender:
Summary
Background:
- Diabetic macular edema is a common eye complication of diabetes. It causes the blood
vessels in the retina at the back of the eye to leak, causing swelling. The macula is
the center part of the retina that is important for seeing fine details and for tasks
such as reading, driving, or sewing. Swelling of the macula leads to vision loss and
possible blindness. Inflammation may play a role in diabetic macular edema. It is also
possible that there is a problem with the blood vessels and the blood supply to cells of
the retina.
- A chemical in the body called vascular endothelial growth factor (VEGF) is important in
the formation of blood vessels in the body. Lowering VEGF levels may help treat diabetic
macular edema by reducing abnormal leaking blood vessels in the eye. Drugs that can
lower or block VEGF include ranibizumab and bevacizumab. Both drugs have been shown to
help treat diabetic macular edema. Researchers want to see if one of the drugs works
better than the other.
Objective: To compare the effectiveness of ranibizumab and bevacizumab injections for
diabetic macular edema.
Eligibility: Individuals at least 18 years of age who have diabetic macular edema in at least
one eye.
Design:
- Participants will be screened with a physical exam and medical history. A full eye exam
will be performed. Blood and urine samples will be collected.
- One eye will be selected as the study eye to receive treatment. If both eyes are
affected, both eyes may be enrolled in the study and receive different drug treatments.
- The main part of the study will last for 9 months. At each study visit, participants
will have physical exams and eye exams. They will answer questions about their health
and any side effects from the drugs.
- Participants will be assigned to one of four groups. Two groups will have two series of
ranibizumab and one series of bevacizumab shots. The other two groups will have two
series of bevacizumab and one series of ranibizumab shots. A series is three eye
injections of the same drug every 4 weeks. The injections will be given at these study
visits. The series order will vary for the different groups.
- After 9 months, participants will continue to have additional study visits. If the
treatment seems to be successful, the study doctor may increase the time between visits.
Study injections may be given as needed every 4 weeks for up to 3 years.
- Participants may have laser treatments in a study eye if needed. After being in the
study for 1 year, they may also have steroid injections or other treatments as directed
for the macular edema.