Detection of Neutralizing Antibodies in Patients Treated With Bevacizumab or Ranibizumab

Completed

Conditions studied: Macular Degeneration

In brief

This study will measure antibody levels in the blood of people with bleeding or swelling in the retina who have or have not been treated with bevacizumab (Avastin\[Trademark\]or ranibizumab (Lucentis\[Trademark\]). These drugs have been useful in reducing retinal bleeding and swelling in people with eye diseases that cause these symptoms, but the drugs' effects usually wear off and they have to be given repeatedly. In some patients, the benefits become less and less. It is possible that over time, patients taking these drugs may produce antibodies that act against the drugs, thus neutralizing their effects and preventing them from working properly. People 18 year of age and older who are participating in a current NEI protocol and meet the following criteria may be eligible for this study: * Are receiving injections of bevacizumab or ranibizumab for bleeding or swelling in the retina, but the treatment is becoming less effective * Are receiving injections of bevacizumab or ranibizumab for bleeding or swelling in the retina and the treatment is still effective * Have bleeding or swelling in the retina, but have never received either bevacizumab or ranibizumab Participants have blood samples drawn once when they start the study, once in the middle of the study, and once at the end of the study. They are asked permission for study researchers to review the results of their eye examinations at NIH.

Key facts

Study ID

NCT00605943

Run by

National Eye Institute (NEI)

People needed

30

Starts

2008-01-16

Expected to finish

2009-08-04

Last updated by the study team

2017-07-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may not qualify if…

• Patients in the following categories will be excluded from participating in this study:
• Patients who are currently receiving any form of systemic immunosuppressive or immunomodulatory therapy, including corticosteroids. Immunosuppressive medication could lower the titers of neutralizing that are present in a given patient, and this could give the false impression that such a patient has little to no immune response against bevacizumab or ranibizumab.
• Patients who have autoimmune or rheumatologic disease. Patients with autoimmune diseases tend to have various autoantibodies in their serum. These naturally present autoantibodies in this patient group could cross-react with bevacizumab or ranibizumab. This would give the false impression that these patients have developed neutralizing antibodies against bevacizumab or ranibizumab, when in fact these naturally occurring cross-reactive autoantibodies were present in the patient all along and are not related to bevacizumab or ranibizumab exposure.
• Patients with evidence of active systemic infection. Patients with active systemic infection could have various antibodies in the serum, and some of these could cross-react with bevacizumab or ranibizumab. This would give the false impression that these patients have developed neutralizing antibodies against bevacizumab or ranibizumab, when in fact these cross-reactive antibodies were present in the patient secondary to the presence of active systemic infection and are not related to bevacizumab or ranibizumab.

Where it is running

• National Institutes of Health Clinical Center, 9000 Rockville Pike — Bethesda, Maryland, United States

Full record on ClinicalTrials.gov

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