A Study to Compare Anti-VEGF Agents in the Treatment of DME (CADME)
Research type
Research Study
Full title
A Phase II Randomized Study to Compare Anti-VEGF Agents in the Treatment of Diabetic Macular Edema (CADME)
IRAS ID
117200
Contact name
Clare Bailey
Sponsor organisation
The National Eye Institute
Eudract number
2012-005486-13
Clinicaltrials.gov Identifier
Research summary
Diabetic macular oedema (DME) 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. Swelling of the macula leads to vision loss and possible blindness. Inflammation may play a role in DME. 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 VEGF is important in the formation of blood vessels in the body. Lowering VEGF levels may help treat DME 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 DME. The objective of this study is to compare the effectiveness of ranibizumab and bevacizumab injections for diabetic DME. Individuals at least 18 years of age who have diabetic macular edema in at least one eye are eligible. The main part of the study will last for 9 months. 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 series order will vary for the different groups. After 9 months, participants will continue to have additional study 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 oedema.
REC name
South West - Central Bristol Research Ethics Committee
REC reference
12/SW/0377
Date of REC Opinion
5 Feb 2013
REC opinion
Further Information Favourable Opinion