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Detection of Neutralizing Antibodies in Patients Treated With Bevacizumab or Ranibizumab

NCT00605943 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 30

Last updated 2017-07-02

No results posted yet for this study

Summary

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.

Conditions

  • Macular Degeneration

Sponsors & Collaborators

  • National Eye Institute (NEI)

    lead NIH

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-01-16
Primary Completion
2009-08-04
Completion
2009-08-04

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00605943 on ClinicalTrials.gov