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Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Dr
Clare
Bailey
clare.bailey@bristol.ac.uk
Mrs
Clemence
Rouquette
clemence.rouquette@uhbristol.nhs.uk
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
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.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Interventional type: Not Specified;
You can take part if:
You may not be able to take part if:
(1) Participant is in another investigational study and actively receiving investigational product for DME. (2) Participant has a known hypersensitivity to sodium fluorescein dye. (3) Participant has a condition that, in the opinion of the investigator, would preclude participation in the study (e.g., unstable medical status including blood pressure and glycemic control). (4) Participant has a history of chronic renal failure requiring dialysis or kidney transplant. (5)Participant has a history of liver failure. (6) Participant has a known hypersensitivity to bevacizumab, ranibizumab or any of their components. (7) Participant has a blood pressure of > 180/110 (systolic above 180 OR diastolic above 110). If blood pressure is brought below 180/110 by anti-hypertensive treatment, a patient can become eligible. (8) Participant has a history of treatment with oral steroids ( ≥ 10 mg of prednisone daily or equivalent) within three months prior to enrolment. Non-ocular depot and inhaled steroid treatments will not exclude a participant. (9) Participant has a history of treatment with systemic anti-VEGF agents within four weeks prior to enrolment.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Mrs
Clemence
Rouquette
clemence.rouquette@uhbristol.nhs.uk
Dr
Clare
Bailey
clare.bailey@bristol.ac.uk
The study is sponsored by UNIVERSITY HOSPITALS BRISTOL AND WESTON NHS FOUNDATION TRUST and funded by National Eye Institute (NIH NEI) .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 14314
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
